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Cork woman felt like she lost part of herself after going into menopause aged 27 – RSVP Live

Posted: October 13, 2022 at 2:40 am

Cork woman Jess N Mhaolin was just 27 years old when she went into menopause.

Jess had always had trouble with her periods as a teenager, she would miss days of school because of the debilitating pain.

The first time I remember being in hospital because of my periods, I was about 15, she told RSVP.

The doctors thought it was my appendix. Then they found ovarian cysts on the ultrasound. There was very much the attitude that Id grow out of it.

Read more: Limerick mum says hormone replacement therapy has changed her life after menopause

In her 20s, Jesss symptoms got worse, but she still felt like she wasnt taken seriously by doctors.

I had a consultant tell me to go away and have a baby and that would sort it out, she said. I changed consultants I dont know how many times. A few people said it might be IBS so I tried a low FODMAP diet. That didnt work. I tried natural remedies, I tried yoga, I tried different painkillers. None of it worked.

Around 2017, Jess was finally diagnosed with endometriosis, a condition that causes cells similar to the lining of the uterus to grow outside the uterus. She was put on a treatment that put her system to sleep.

In theory, that sounded great, because I wasnt getting periods anymore so I wasnt in pain, admitted Jess.

In reality, it was shutting down my hormone centre. I couldnt regulate my temperature. I was nauseous all the time. I was severely bloated. I was having terrible mood swings.

The next step for Jess was to go through surgical treatment and during this stage, doctors discovered problems with her ovaries. She had to have emergency surgery to have her right ovary removed because there was a growth on it, and her left ovary had stopped working because it was covered in adhesions.

She went to a specialist surgeon in the UK to have treatment on the left ovary but when she was there, she was given some devastating news.

During my scan, the consultant basically stopped what he was doing, sat me down and explained that my left ovary had practically shut down, Jess added.

He asked me if I had suffered menopausal symptoms. I had been experiencing them but Id been through so many operations that I thought it was part of the recovery process.

An hour later, Jesss surgeon gave her her options: but the most practical one was a full hysterectomy.

He gave me some time to think and I remember standing in the middle of Harley Street in London, just crying, she recalled. I had this whole future mapped out in front of me in my head. I thought Id be settled at 30, be buying a house and probably having a baby with someone.

All of a sudden Im 27, in a country that isnt home, being given this devastating news. It was like someone had taken a piece out of my heart that I was never going to get back.

Jess went through with the hysterectomy, but her road hasnt been easy.

Most of my friends are at the age now where they are having their first or second child, or theyre pregnant, she continued.

Im not in a relationship. Part of that is by choice, because I'm married to my job. But part of it is: How do you approach the subject of not being able to have kids with someone? Do you tell them straight away? Do you tell them a few dates in?

Now 30 years old, Jess struggles with the side effects of menopause, but hormone replacement therapy has really helped.

Im on oestrogen and testosterone gel, and it makes such a difference. If I forget to use it or I dont use enough, I would feel towards the end of the day that I would start to get anxious, the brain fog would begin and I would get hot flushes.

My mum is actually going through menopause at the same time as me, so I can talk to her about it which is comforting but also sad.

The Government policy advisor said she is happy to share her story because she wants to help other women.

I thought menopause was something that happened to you when you were maybe 55, when youd had your kids, she said. If I had known that I was having menopausal symptoms before that last scan, maybe I would have had enough time to freeze my eggs. Its hard to know, and I could drive myself mad thinking about it.

Women can get menopause in their 30s for various reasons, so its important to know the symptoms and always advocate for yourself.

Visit The Menopause Hub's website here for more information.

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Soils, Plant Nutrition and Nutrient Management | MU Extension

Posted: October 13, 2022 at 2:37 am

Missouri Master Gardener Core ManualManjula V. NathanSoil Testing and Plant Diagnostic Service Laboratory

Soil as a medium for plant growth can be described as a complex natural material derived from weathering of rocks and decomposition of organic materials, which provide nutrients, moisture and anchorage for plants.

Soil is a mixture of minerals, organic matter (humus), air and water. An ideal soil for plant growth is about 50 percent solids consisting of minerals and organic material (Figure 1). The organic portion consists of residues from plants, animals and other living organisms. Under optimum conditions for plant growth, about half of the space between soil particles pore space is filled with water, and the remainder with air. Soil compaction reduces pore space and the amount of air and water the soil can hold, thereby restricting root growth and the ability of plants to take up nutrients from the soil.

Figure 1Volumetric content of four principal soil components for an ideal soil at ideal moisture content for plant growth.

Soil colorThe color of soil has little effect on plant growth but is an indicator of soil properties that do affect plant development. Color is an indicator of organic matter content, drainage and aeration.

Soil structureSoil structure refers to the arrangement of soil particles into aggregates. Any physical disturbance influences soil structure. The addition of calcium (Ca), magnesium (Mg) or organic matter improves the structure of soil by enhancing aggregation, the ability of soil particles to hold together as a coherent mixture. Organic matter acts as a bonding agent in holding soil particles together to form aggregates. Excessive sodium (Na) levels in soils cause dispersion of soil particles that can result in poor soil structure. Development of desirable soil structure increases porosity (the amount of pore space in the soil), reduces erodibility and improves water-holding capacity, root penetration and ease of tillage.

Soil textureSoil texture refers to the percentage of sand (2.0 to 0.05 mm), silt (0.05 to 0.002 mm) and clay particles (less than 0.002 mm) that make up the mineral portion of the soil (Figure 2). Loam is a variable mix of these three textural classes.

Figure 2The soil textural triangle shows the percentage of sand, silt and clay in each of the textural classes. Soil texture can be measured accurately in a laboratory. Soil texture can also be estimated in the field by a hand-feel method (see Table 1).

Table 1. Soil texture as defined by soil texture class and estimated by a hand-feel method.

Soil organic matterSoil organic matter, or humus, is the partially decomposed residue of plants, animals and other organisms. Organic matter refers to all organic material in the soil, including fresh crop residues.

Organic matter improves soil structure by acting as a bonding agent that holds soil particles together in aggregates. Without organic matter, aggregates are less stable and can be easily broken apart. Good soil structure promotes water movement and root penetration while reducing soil crusting, clod formation and erosion.

Organic matter provides plant nutrients, mainly nitrogen and sulfur and smaller amounts of phosphorus. About 20 pounds of nitrogen are released by decomposition of every 1 percent of organic matter in the soil. Organic matter is a primary reservoir for available forms of micronutrients (mainly zinc and boron).

Soil organic matter also improves the cation exchange capacity of the soil, its ability to hold positively charged molecules, or ions, of mineral nutrients.

Soil organismsSoil organisms vary in size from microscopic bacteria, fungi and algae to those visible to the naked eye, such as earthworms and insects. They perform both beneficial and detrimental functions in the soil.

Microbes decompose organic matter and release nutrients for plant uptake. Bacteria called rhizobia are responsible for fixing atmospheric nitrogen as plant-available forms in root nodules on legumes. Some fungi and nematodes are responsible for plant diseases, and many soil insects damage crops.

Fertilizer has positive effects on soil microorganisms by providing more nutrients and increased crop residues. Application of anhydrous ammonia will temporarily reduce populations of microorganisms in the zone of application.

Soil pHSoil pH is a relative measure of the hydrogen ion concentration (H+) in the soil. The pH value can vary from a minimum value of 0 to a maximum value of 14.

Soil pH affects the availability of nutrients to plants (Figure 3). In acid soils (pH is low) calcium and magnesium become more available to plants, whereas the micronutrients iron, aluminum and manganese become soluble and can reach levels toxic to plants. These micronutrients also can react with phosphorus to form compounds that are insoluble and not available to plants. In alkaline soils (pH is high), several soil micronutrients, including zinc, copper and cobalt, become less available to plants. Also at high pH, phosphorus precipitates (becomes insoluble) with the higher levels of calcium in the soil and therefore becomes less available to plants.

Soil pH affects the population and activity of microorganisms. The activity of nitrogen-fixing bacteria associated with legumes is impaired in acid soils, resulting in less nitrogen fixation.

Several natural processes cause most soils to become more acidic over time:

Figure 3Soil pH affects nutrient availability to plants. The width of the band indicates the relative availability of each plant nutrient at various pH levels.

Cation exchange capacityCation exchange capacity (CEC) is a measure of the total amount of exchangeable cations (positively charged ions) a soil can adsorb. Nutrient cations in the soil include positively charged ions such as calcium (Ca+2), magnesium (Mg+2), potassium (K+), sodium (Na+) and hydrogen (H+). In soil tests, CEC is reported in milliequivalents (meq) per 100 grams of soil. The exchangeable cations in the soil are in equilibrium with those in the soil solution (water in the soil). As plants remove nutrients (cations) from the soil solution, they are replenished from the adsorbed cations, which are then available for plant uptake (Figure 4).

Figure 4Exchangeable nutrient cations adsorbed on soil particles exist in equilibrium with cations in the soil solution. Cations from the particles replenish those taken up from the soil solution by plants.

Table 2. The higher the clay content of the soil, the greater its cation exchange capacity (CEC).

Anion retention in soilsAnions are negatively charged ions. They are retained by positively charged surfaces in the soil, but only in negligible amounts. Negatively charged ions, such as nitrate and phosphate anions, are repelled by clay/humus particles, which are also negatively charged. For this reason, anions are susceptible to leaching losses in soil solutions.

Seventeen elements are considered essential nutrients for plant growth, and 14 of these elements come from the soil (Table 3). If there is a deficiency of any essential element, plants cannot complete their vegetative or reproductive cycles. Some of these nutrients combine to form compounds that make up cells and enzymes. Other nutrients are necessary for certain chemical processes to occur.

Table 3. Seventeen essential plant nutrients derived from air, water and soil.

Concept of most limiting nutrientJust as the capacity of a wooden bucket to hold water is determined by the height of the short stave, crop yields are restricted by the soil nutrient in shortest supply (Figure 5). Increasing the height of the nitrogen (N) stave in the bucket does not increase the buckets capacity. In Figure 4, unless sulfur fertility is improved, the value of other fertilizer nutrients is reduced. Soil testing discovers the limiting nutrients (short staves) and maximizes fertilizer returns.

Figure 5The most limiting nutrient in a soil determines the growth and reproduction of plants.

Nitrogen is a building block of plant proteins. It is an integral part of chlorophyll and is a component of amino acids, nucleic acids and coenzymes.

Most nitrogen in the soil in tied up in organic matter. It is taken up by plants as nitrate (NO3-) and ammonium (NH4+) ions from inorganic nitrate and ammonium compounds. These compounds can enter the soil as a result of bacterial action (nitrogen fixation), application of inorganic nitrogen fertilizer, or conversion of organic matter into ammonium and nitrate compounds.

Not all nitrates in the soil are taken up by plants. Nitrates can be leached beyond the root zone in sandy soils or converted to nitrogen gas in wet, flooded soils. Nitrogen fixation by soil microbes immobilizes nitrogen, making in available for later use by plants.

A soil test is the best way to determine how much nitrogen fertilizer should be added to your soil. Application rates for specific crops are based on typical yield goals, the organic matter content of the soil, the previous crop produced on that soil, and the amount of manure used.

Plants use phosphorus to form the nucleic acids DNA and RNA and to store and transfer energy. Phosphorus promotes early plant growth and root formation through its role in the division and organization of cells. Phosphorus is essential to flowering and fruiting and to the transfer of hereditary traits.

Phosphorus is adsorbed by plants as H2PO4-, HPO4-2 or PO-3, depending upon soil pH. The mobility of phosphorus in soil is low, and deficiencies are common in cool, wet soils.

Phosphorus should be applied to fields and gardens before planting and should be incorporated into the soil. This is especially important for perennial crops. Application rates should be based on soil testing.

Potassium is necessary to plants for translocation of sugars and for starch formation. It is important for efficient use of water through its role in opening and closing small apertures (stomata) on the surface of leaves. Phosphorus increases plant resistance to diseases and assists in enzyme activation and photosynthesis. It also increases the size and quality of fruits and improves winter hardiness.

Plants take up potassium in the form of potassium ions (K+). It is relatively immobile in soils but can leach in sandy soils. Potassium fertilizer should be incorporated into the soil at planting or before. Application rates should be based on a soil test.

Calcium provides a building block (calcium pectate) for cell walls and membranes and must be present for the formation of new cells. It is a constituent of important plant carbohydrates, such as starch and cellulose. Calcium promotes plant vigor and rigidity and is important to proper root and stem growth.

Plants adsorb calcium in the form of the calcium ion (Ca+2). Calcium needs can be only determined by soil test. In most cases calcium requirements are met by liming the soil. Potatoes are an exception; use gypsum (calcium sulfate) on potatoes to avoid scab disease if calcium is needed. Gypsum provides calcium to the soil but does not raise the pH level of the soil. Keeping pH low helps prevent growth of the bacteria that cause scab disease.

Magnesium is a component of the chlorophyll molecule and is therefore essential for photosynthesis. Magnesium serves as an activator for many plant enzymes required for sugar metabolism and movement and for growth processes. Plants take up magnesium as the Mg+2 ion.

Sulfur is a constituent of three amino acids (cystine, methionine and cysteine) that play an essential role in protein synthesis. Sulfur is present in oil compounds responsible for characteristic odors of plants such as garlic and onion. It is also essential for nodule formation on legumes.

Plants take up sulfur in the form of sulfate (SO4-2) ions. Sulfur can also be adsorbed from the air through leaves in areas where the atmosphere has been enriched with sulfur compounds from industrial wastes. Sulfur is susceptible to leaching, and sulfur deficiencies can occur in sandy soils low in organic matter. Sulfur needs can be only determined by a soil test.

Zinc is an essential component of several enzymes in plants. It controls the synthesis of indoleacetic acid, an important plant growth regulator, and it is involved in the production of chlorophyll and protein. Zinc is taken up by plants as the zinc ion (Zn+2).

Zinc deficiencies are more likely to occur in sandy soils that are low in organic matter. High soil pH, as in high-lime soils, the solubility of zinc decreases and it becomes less available. Zinc and phosphorus have antagonistic effects in the soil. Therefore zinc also becomes available in soils that are high in phosphorus. Wet and cold soil conditions can cause zinc deficiency because of slow root growth and slow release of zinc from organic matter.

Iron is taken up by plants as ferrous ion (Fe+2). Iron is required for the formation of chlorophyll in plant cells. It serves as an activator for biochemical processes such as respiration, photosynthesis and symbiotic nitrogen fixation. Turf, ornamentals and certain trees are especially susceptible to iron deficiency, although in general, lack of iron in the soil is not a problem. Symptoms of iron deficiency can occur on soils with pH greater than 7.0. Specific needs for iron can be determined by soil test, tissue test and visual symptoms.

Manganese serves as an activator for enzymes in plant growth processes, and it assists iron in chlorophyll formation. Plants obtain this nutrient from the soil in the form of manganous ion (Mn+2).

Manganese deficiency in soils is not common but can occur in sandy soils with a pH of 8. Soil pH is a good indicator of manganese availability, which can increase to toxic levels in highly acidic soils (pH less than 4.5). Crops most responsive to manganese are onions, beans, potato, spinach, tomato, peas, raspberries, strawberries, apples and grapes.

Copper is an activator of several enzymes in plants. It may play a role in production of vitamin A. Deficiency interferes with protein synthesis.

Copper deficiencies are not common in soils. Plants take up copper from the soil in the form of cuprous (Cu+) or cupric (Cu+2) ions. Crops most responsive to copper are carrots, lettuce, onions and spinach.

Boron regulates the metabolism of carbohydrates in plants. It is essential for the process by which meristem cells (cells that divide) differentiate to form specific tissues. With boron deficiency, plant cells may continue to divide, but structural components are not differentiated.

Boron is taken up by plants as the borate ion (BO3-). Plants differ in their boron needs. Plants with high boron requirements are cauliflower, broccoli, turnip, brussels sprouts, apples, celery and alfalfa. Boron can be limiting on sandy soils low in organic matter. Do not overapply, because boron toxicity can occur ( e.g., beans). Soil testing for boron can predict fertilizer requirement.

Molybdenum is taken up by plants as molybdate ions (MoO4-). Molybdenum is an essential micronutrient that enables plants to make use of nitrogen. Without molybdenum, plants cannot transform nitrate nitrogen to amino acids and legumes cannot fix atmospheric nitrogen.

Molybdenum deficiency can occur in acidic, sandy soils. Liming the soil to pH 6 will correct the problem. Soil applications, foliar applications or coating seed with molybdenum are also effective. Cauliflower is the main vegetable crop sensitive to low levels of molybdenum in the soil.

Chlorine is required in photosynthetic reactions. Deficiency of chlorine in soils is rare because of its universal presence in nature. Plants take up chlorine as chloride ion (Cl-).

Nickel is taken up by plants as Ni+2. Nickel is a component of the enzyme urease, which is needed to prevent toxic accumulations of urea, a product of nitrogen metabolism in plants. Nickel is thought to participate in nitrogen metabolism of legumes during the reproductive phase of growth. It is also essential for seed development. High levels of nickel in the soil can induce zinc or iron deficiency by competition between these elements in plant uptake.

The soil test is an excellent gauge of soil fertility. It is an inexpensive way to maintain good plant health and maximum productivity without polluting the environment by overapplication of nutrients.

Soil fertility fluctuates throughout the growing season each year. The quantity and availability of mineral nutrients are altered by the addition of fertilizers, manure, compost, mulch, lime or sulfur and by leaching. Furthermore, large quantities of mineral nutrients are removed from soils as a result of plant growth and development and the harvesting of crops. A soil test will determine the current fertility status. It also provides the information needed to maintain optimum fertility year after year.

Some plants grow well over a wide range of soil pH, while others grow best within a narrow range of pH. Most turf grasses, flowers, ornamental shrubs, vegetables and fruits grow best in slightly acid soils (pH 6.1 to 6.9). Plants such as rhododendron, azalea, pieris, mountain laurel and blueberries require a more acidic soil to grow well. A soil test is the only precise way to determine whether the soil is acidic, neutral or alkaline.

A soil test takes the guesswork out of fertilization and is extremely cost effective. It not only eliminates the expense of unnecessary fertilizers but also eliminates overuse of fertilizers and helps to protect the environment.

When is the best time for a soil test?Soil samples can be taken in the spring or fall for established sites. For new sites, soil samples can be taken anytime when the soil is workable. Most people conduct their soil tests in the spring. However, fall is a preferred time to take soil tests if one suspects a soil pH problem and wants to avoid the spring rush. Fall soil testing will allow you ample time to apply lime to raise the soil pH. Sulfur should be applied in the spring if the soil pH needs to be lowered.

How to take a soil sample?Most errors in soil testing occur when the sample is taken. Potential sources of errors include the following:

Taking a representative sample is important in soil testing. Use a trowel, spade and sampling tube/core samplers.

What soil sampling tools do I need?A soil sample is best taken with a soil probe or an auger. Samples should be collected in a clean plastic pail or box. These tools help ensure an equal amount of soil to a definite depth at the sampling site. However, a spade, knife, or trowel can also be used to take thin slices or sections of soil.

Push the tip of a spade deep into the soil and then cut a 1/2-inch to 1-inch slice of soil from the back of the hole. Be sure the slice goes 6 inches deep and is fairly even in width and thickness. Place this sample in the pail. Repeat five or six times at different spots over your garden. Thoroughly mix the soil slices in the pail. After mixing thoroughly, take out about 1-1/2 cup of soil and mail or, preferably, take it to your University Extension center. You can also mail or deliver it to the MUSoil and Plant Testing Laboratory in Columbia or at the Delta Research Center in Portageville. It is important that you fill out the soil sample information form (Figure 5) completely and submit it with your sample. By indicating on the form the crops you wish to grow, you can get specific recommendations.

How often should I test my soil?Soil should be tested every two to three years. In sandy soils, where rainfall and irrigation rates are high, samples should be taken annually.

What tests should be run? In general a regular fertility test is sufficient. This includes measurement of pH, neutralizable acidity (NA), phosphorus, potassium, calcium, magnesium, organic matter (OM) and cation exchange capacity (CEC).

What do the test result numbers mean?Some labs report soil test values as amounts of available plant nutrients, and others report extractable nutrients that will become available to the plants (Figure 6). Fertilizer rates are given in pounds of actual nutrient (as distinct from pounds of fertilizer) to be applied per 1,000 square feet.

MP555, Soil Sample Information for Lawn and Garden form, for MU soil testing laboratories is available online and at MU Extension centers.

Figure 6. A soil test report from the University of Missouri Soil and Plant Testing Laboratory shows the results of soil analysis and recommends fertilizer and limestone needs to improve plant health and productivity.

All fertilizer recommendations given in a soil test report are based on the amount of nutrient (N, P2O5, K2O) to apply for a given area. Lawn and garden recommendations are given in pounds (lb) per 1,000 square feet (sq ft). From the given recommendations it is necessary to select an appropriate fertilizer grade and determine how much of this fertilizer to apply to the garden area. Numbers on fertilizer bags indicate the exact percentages of nutrients by weight: 100 lb of 5-10-10 fertilizer contains 5 lb of nitrogen (N), 10 lb of phosphate (P2O5), and 10 lb of potash (K2O). Because it is difficult to achieve the exact amount of all recommended nutrients from the garden fertilizer blends available in the market, it is important to match the nitrogen requirement.

ExampleA soil test recommendation for your vegetable garden calls for 2 lb of N/1,000 sq ft, 0 lb of P2O5 /1,000 sq ft and 1 lb of K2O. The garden is 40 ft by 10 ft.

NoteThe weight of 2 cups of dry fertilizer is about 1 pound. Therefore, to meet the garden fertilizer recommendation, you will need about 6 cups of the fertilizer blend (25-0-12) material for the 400 sq ft area.

Recommended application rate for various granular fertilizers to apply 1 pound of nitrogen.

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Soils, Plant Nutrition and Nutrient Management | MU Extension

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World’s first stem cell treatment for spina bifida delivered during fetal surgery – UC Davis Health

Posted: October 13, 2022 at 2:34 am

(SACRAMENTO)

Three babies have been born after receiving the worlds first spina bifida treatment combining surgery with stem cells. This was made possible by a landmark clinical trial at UC Davis Health.

The one-of-a-kind treatment, delivered while a fetus is still developing in the mothers womb, could improve outcomes for children with this birth defect.

Launched in the spring of 2021, the clinical trial is known formally as the CuRe Trial: Cellular Therapy for In Utero Repair of Myelomeningocele. Thirty-five patients will be treated in total.

The three babies from the trial that have been born so far will be monitored by the research team until 30 months of age to fully assess the procedures safety and effectiveness.

The first phase of the trial is funded by a $9 million state grant from the states stem cell agency, the California Institute for Regenerative Medicine (CIRM).

This clinical trial could enhance the quality of life for so many patients to come, said Emily, the first clinical trial participant who traveled from Austin, Tex. to participate. Her daughter Robbie was born last October. We didnt know about spina bifida until the diagnosis. We are so thankful that we got to be a part of this. We are giving our daughter the very best chance at a bright future.

Spina bifida, also known as myelomeningocele, occurs when spinal tissue fails to fuse properly during the early stages of pregnancy. The birth defect can lead to a range of lifelong cognitive, mobility, urinary and bowel disabilities. It affects 1,500 to 2,000 children in the U.S. every year. It is often diagnosed through ultrasound.

While surgery performed after birth can help reduce some of the effects, surgery before birth can prevent or lessen the severity of the fetuss spinal damage, which worsens over the course of pregnancy.

Ive been working toward this day for almost 25 years now, said Diana Farmer, the worlds first woman fetal surgeon, professor and chair of surgery at UC Davis Health and principal investigator on the study.

As a leader of the Management of Myelomeningocele Study (MOMS) clinical trial in the early 2000s, Farmer had previously helped to prove that fetal surgery reduced neurological deficits from spina bifida. Many children in that study showed improvement but still required wheelchairs or leg braces.

Farmer recruited bioengineer Aijun Wang specifically to help take that work to the next level. Together, they launched theUC Davis Health Surgical Bioengineering Laboratoryto find ways to use stem cells and bioengineering to advance surgical effectiveness and improve outcomes. Farmer also launched the UC Davis Fetal Care and Treatment Centerwith fetal surgeon Shinjiro Hirose and the UC DavisChildrens Surgery Center several years ago.

Farmer, Wang and their research team have been working on their novel approach using stem cells in fetal surgery for more than 10 years. Over that time, animal modeling has shown it is capable of preventing the paralysis associated with spina bifida.

Its believed that the stem cells work to repair and restore damaged spinal tissue, beyond what surgery can accomplish alone.

Preliminary work by Farmer and Wang proved that prenatal surgery combined with human placenta-derived mesenchymal stromal cells, held in place with a biomaterial scaffold to form a patch, helped lambs with spina bifida walk without noticeable disability.

When the baby sheep who received stem cells were born, they were able to stand at birth and they were able to run around almost normally. It was amazing, Wang said.

When the team refined their surgery and stem cells technique for canines, the treatment also improved the mobility of dogs with naturally occurring spina bifida.

A pair of English bulldogs named Darla and Spanky were the worlds first dogs to be successfully treated with surgery and stem cells. Spina bifida, a common birth defect in this breed, frequently leaves them with little function in their hindquarters.

By their post-surgery re-check at 4 months old, Darla and Spanky were able to walk, run and play.

When Emily and her husband Harry learned that they would be first-time parents, they never expected any pregnancy complications. But the day that Emily learned that her developing child had spina bifida was also the day she first heard about the CuRe trial.

For Emily, it was a lifeline that they couldnt refuse.

Participating in the trial would mean that she would need to temporarily move to Sacramento for the fetal surgery and then for weekly follow-up visits during her pregnancy.

After screenings, MRI scans and interviews, Emily received the life-changing news that she was accepted into the trial. Her fetal surgery was scheduled for July 12, 2021, at 25 weeks and five days gestation.

Farmer and Wangs team manufactures clinical grade stem cells mesenchymal stem cells from placental tissue in the UC Davis Healths CIRM-funded Institute for Regenerative Cures. The cells are known to be among the most promising type of cells in regenerative medicine.

The lab is aGood Manufacturing Practice(GMP) Laboratory for safe use in humans. It is here that they made the stem cell patch for Emilys fetal surgery.

Its a four-day process to make the stem cell patch, said Priya Kumar, the scientist at the Center for Surgical Bioengineering in the Department of Surgery, who leads the team that creates the stem cell patches and delivers them to the operating room. The time we pull out the cells, the time we seed on the scaffold, and the time we deliver, is all critical.

During Emilys historic procedure, a 40-person operating and cell preparation team did the careful dance that they had been long preparing for.

After Emily was placed under general anesthetic, a small opening was made in her uterus and they floated the fetus up to that incision point so they could expose its spine and the spina bifida defect. The surgeons used a microscope to carefully begin the repair.

Then the moment of truth: The stem cell patch was placed directly over the exposed spinal cord of the fetus. The fetal surgeons then closed the incision to allow the tissue to regenerate.

The placement of the stem cell patch went off without a hitch. Mother and fetus did great! Farmer said.

The team declared the first-of-its-kind surgery a success.

On Sept. 20, 2021, at 35 weeks and five days gestation, Robbie was born at 5 pounds, 10 ounces, 19 inches long via C-section.

One of my first fears was that I wouldnt be able to see her, but they brought her over to me. I got to see her toes wiggle for the first time. It was so reassuring and a little bit out of this world, Emily said.

For Farmer, this day is what she had long hoped for, and it came with surprises. If Robbie had remained untreated, she was expected to be born with leg paralysis.

It was very clear the minute she was born that she was kicking her legs and I remember very clearly saying, Oh my God, I think shes wiggling her toes! said Farmer, who noted that the observation was not an official confirmation, but it was promising. It was amazing. We kept saying, Am I seeing that? Is that real?

Both mom and baby are at home and in good health. Robbie just celebrated her first birthday.

The CuRe team is cautious about drawing conclusions and says a lot is still to be learned during this safety phase of the trial. The team will continue to monitor Robbie and the other babies in the trial until they are 6 years old, with a key checkup happening at 30 months to see if they are walking and potty training.

This experience has been larger than life and has exceeded every expectation. I hope this trial will enhance the quality of life for so many patients to come, Emily said. We are honored to be part of history in the making.

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JDRF Announces the Appointment of Qizhi Tang, Ph.D., as Co-Director of The JDRF Center of Excellence in Northern California – PR Newswire

Posted: October 13, 2022 at 2:34 am

NEW YORK and SAN FRANCISCO, Oct. 10, 2022 /PRNewswire/ -- JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, together with the University of California, San Francisco (UCSF), announce the appointment of Qizhi Tang, Ph.D.,professor of surgery and director of the UCSF Transplantation Research Laboratory, as the new co-director of theJDRF Center of Excellence in Northern California. In her new role, Dr. Tang will co-lead the institution with Seung Kim, M.D., Ph.D., as the center works to deliver next-generation therapies and first-generation cures for T1D.

"Dr. Tang has been a key leader at the JDRF Center of Excellence in Northern California since its inception," said Esther Latres, JDRF assistant vice president of research. "Her experience in immunology, clinical transplantation, and beta cell replacement therapy will be an added asset as the center expands. The combined leadership of Dr. Tang and Dr. Kimwill undoubtedly accelerate research toward developing new approaches to generate highly functional islets and protect them from the immune system after transplantation."

JDRF announces Qizhi Tang, Ph.D., as the new co-director of the JDRF Center of Excellence in Northern California.

Dr. Tang joined the UCSF faculty in 2002 as an assistant professor of pathology and at the Diabetes Center, where she researched mechanisms of immune tolerance in mouse models of T1D. In 2007 Dr. Tang was appointed the director of the UCSF Transplantation Research Laboratory and joined the transplantation division in the Department of Surgery to lead basic and translational research in transplant immunology. In that role, she has built cross-disciplinary collaborative teams to rapidly translate laboratory discoveries into early-phase clinical trials.

"Dr. Tang is an outstanding, highly collaborative scientist and leader of scientific programs, and we are privileged to have her assume this important role," said Dr. Seung Kim, M.D., Ph.D., JDRF Center of Excellence in Northern California co-director. "Her focus on type 1 diabetes immune therapeutics and pathogenesis have been framed by productive studies, often at multiple institutions, and perfectly align with her leadership in the Center of Excellence. I am pleased to co-direct and collaborate with her."

"A confluence of knowledge and technology makes this an exciting time for T1D research," said Dr. Qizhi Tang. "The support of the JDRF Center of Excellence allows us to recruit talents to translate these research advances into therapies for type 1 diabetes. I am honored to have the opportunity to lead this effort."

The JDRF Center of Excellence in Northern California is a cure accelerator and high-impact partnership combining the scientific expertise of Stanford University and the University of California, San Francisco, within the collaborative structure and support that are hallmarks of JDRF. Investigators at the Center will seek to better understand and target the interactions between the immune system and beta cells, identify new strategies to protect these cells after transplantation, and deliver advanced stem cell-based cures for T1D.

Dr. Tang's tenure as co-director of the Center of Excellence begins immediately, taking over for Dr. Matthias Hebrok, who has been appointed as founding chair of the Center for Organoid Systems and Tissue Engineering (COS) at the Technical University of Munich (TUM) and Director of the new Institute for Diabetes and Organoid Technology (IDOT) at the Helmholtz Center, Germany.

"I have enjoyed being at UCSF for more than 22 years, and it has been a privilege to help build and co-direct the JDRF Center of Excellence in Northern California with the clear intent of finding new ways to treat patients living with type 1 diabetes," said Dr. Hebrok.

Dr. Hebrok's current research will continue under the leadership of Audrey Parent, Ph. D. assistant adjunct professor at the University of California, San Francisco. Dr. Parent has made seminal contributions to understanding how to generate and modify stem cell-derived beta cells to blunt the effects of the immune system.

For more information about The JDRF Center of Excellence in Northern California please visit, https://www.jdrf.org/impact/research/centers-of-excellence/northern-california/

For more information about the JDRF Center of Excellence program, visit https://www.jdrf.org/impact/research/centers-of-excellence/

About JDRF

JDRF's mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a global stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement, and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter (@JDRF), Facebook (@myjdrf), and Instagram (@jdrfhq).

About UCSF

University of California, San Francisco is the leading university exclusively focused on health. Through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in care delivery, UCSF is leading revolutions in health worldwide.

About Type 1 Diabetes (T1D)

T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all, leading to long-term complications which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves and heart; and even death if left untreated. It is one of the fastest-growing chronic health conditions. Many believe T1D is only diagnosed in childhood and early puberty, but diagnosis in adulthood is on the rise, and accounts for nearly 50% of all T1D diagnoses. The onset is sudden and nothing can be done to prevent it yetit is not related to diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D.

SOURCE JDRF

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JDRF Announces the Appointment of Qizhi Tang, Ph.D., as Co-Director of The JDRF Center of Excellence in Northern California - PR Newswire

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Brain-Like Organoids Grown in a Dish Provide Window into Autism – University of Utah Health Care

Posted: October 13, 2022 at 2:33 am

Media Contacts Julie Kiefer

Associate Director, Science Communications, University of Utah HealthEmail: julie.kiefer@hsc.utah.eduPhone: 801-587-1293

Oct 06, 2022 9:00 AM

Whatever you do, dont call them mini-brains, say University of Utah Health scientists. Regardless, the seed-sized organoidswhich are grown in the lab from human cellsprovide insights into the brain and uncover differences that may contribute to autism in some people.

We used to think it would be too difficult to model the organization of cells in the brain, says Alex Shcheglovitov, PhD, assistant professor of neurobiology at U of U Health. But these organoids self-organize. Within a few months, we see layers of cells that are reminiscent of the cerebral cortex in the human brain.

The research describing the organoids and their potential for understanding neural diseases publishes in Nature Communications on Oct 6 with Shcheglovitov as senior author and Yueqi Wang, PhD, a former graduate student in his lab, as lead author. They carried out the research with postdoctoral scientist Simone Chiola, PhD, and other collaborators at the University of Utah, Harvard University, University of Milan, and Montana State University.

These organoids self-organize. Within a few months, we see layers of cells that are reminiscent of the cerebral cortex in the human brain.

Investigating autism

Having the ability to model aspects of the brain in this way gives scientists a glimpse into the inner workings of a living organ that is otherwise nearly impossible to access. And since the organoids grow in a dish, they can be tested experimentally in ways that a brain cannot.

Shcheglovitovs team used this approach to investigate effects of a genetic abnormality associated with autism spectrum disorder and human brain development. They found that organoids engineered to have lower levels of the gene, called SHANK3, had distinct features.

Even though the autism organoid model appeared normal, some cells did not function properly:

These findings are helping to uncover the cellular and molecular causes of symptoms associated with autism, the authors say. They also demonstrate that the lab-grown organoids will be valuable for gaining a better understanding of the brain, how it develops, and what goes wrong during disease.

A key application is to use the brain organoids, derived from the genetic material of each individual patient, to test drugs or other interventions to treat disorders in a personalized manner, says Jan Kubanek, PhD, a co-author on the study and an assistant professor of biomedical engineering at the U. This would truly realize the potential of personalized medicine.

Building a better brain model

Scientists have long searched for suitable models for the human brain. Lab-grown organoids are not new, but previous versions did not develop in a reproduceable way, making experiments difficult to interpret.

To create an improved model, Shcheglovitovs team took cues from how the brain develops normally. The researchers prompted human stem cells to become neuroepithelial cells, a specific stem cell type that forms self-organized structures, called neural rosettes, in a dish. Over the course of months, these structures coalesced into spheres and increased in size and complexity at a rate similar to the developing brain in a growing fetus.

After five months in the lab, the organoids were reminiscent of one wrinkle of a human brain at 15 to 19 weeks post-conception, Shcheglovitov says. The structures contained an array of neural and other cell types found in the cerebral cortex, the outermost layer of the brain involved in language, emotion, reasoning, and other high-level mental processes.

Like a human embryo, organoids self-organized in a predictable fashion, forming neural networks that pulsated with oscillatory electrical rhythms and generated diverse electrical signals characteristic of a variety of different kinds of mature brain cells.

These organoids had patterns of electrophysiological activity that resembled electrophysiological rhythms of the brain. I didnt expect that, Kubanek says. This new approach models functional brain networks of the human nervous tissue.

Shcheglovitov explains that these organoids, which more reliably reflect intricate structures in the cortex, will allow scientists to study how specific types of cells in the brain arise and work together to perform more complex functions.

Were beginning to understand how complex neural structures in the human brain arise from simple progenitors, Wang says. And were able to measure disease-related phenotypes using 3D organoids that are derived from stem cells containing geneticmutations.

He adds that using the organoids, researchers will be able to better investigate what happens at the earliest stages of neurological conditions, before symptoms develop.

# # #

Visit UBrain browser to visualize the cells and electrical responses detected in organoids.

The research published as Modeling human telencephalic development and autism-associated SHANK3 deficiency using organoids generated from single neural rosettes.

Support for the work came from the National Institutes of Health, Brain Research Foundation, Brain and Behavior Research Foundation, Whitehall Foundation, University of Utah Neuroscience Initiative, and University of Utah Genome Project Initiative.

Research News Neuroscience

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CIRI calls for safety advice revamp after health concerns raised by 3D printing emission research – 3D Printing Industry

Posted: October 13, 2022 at 2:32 am

The Chemical Insights Research Institute (CIRI), a non-profit arm of safety research specialist Underwriters Laboratories, has found that 3D printing emissions can be damaging to human health, even in small quantities.

In a recent CIRI toxicity study, researchers found that exposure to the fumes created when printing ABS or PLA filaments, can contribute to airway cellular injury and inflammation. Based on their research, the scientists say that operating extrusion 3D printers from a safe distance, as well as ventilation and filtration mitigation strategies, should be discussed in the safety guidance around these machines.

Getting to the bottom of emissions

According to the researchers behind the paper, Dr. Christa Wright, now formerly of Georgia State University, and CIRI graduate student Jennifer Jeon, their study was prompted by concerns over the harmfulness of fumes emitted by certain printers.

Specifically, as FFF systems heat, cool and manipulate filaments, the scientists believed that the chemical compounds released into the air could be hazardous to operators. Given the growing popularity of 3D printers in STEM educational settings, the pair therefore said it was essential to find out which materials and conditions caused most risk, as well as the consequences of breathing in fumage.

To find out, the researchers cultured small airway epithelial cells in a dish before exposing them to the particulate matter generated via the 3D printing of ABS and PLA, and examining their responses. The team then measured particle emissions over three hours and fed them into a Multiple Path Particle Dosimetry model, capable of determining the impact of prolonged exposure to these, to users lungs.

The CIRI studys toxicity findings

Carried out in July 2021, the researchers experiments confirmed their fears about the damage emissions could be doing to 3D printer users lung cells. Those samples exposed to high doses of ABS printing fumes exhibited a 49.5% decline in viability, and even the dishes further away or in adjacent rooms were affected, albeit to a lesser extent.

The team then turned to metabolomic profiling, a process in which cells can be assessed for high levels of metabolites, the metabolism byproducts associated with cell injury and inflammation. In the case of PLA and ABS, testing showed that fumes emitted when printing these caused cells to be altered, with prostaglandins, compounds that target injuries or infections, being impacted in particular.

Interestingly, while the scientists research showed that both PLA and ABS fumes can be associated with a decline in airway cell viability, oxidative stress, an increase in DNA damage, and high levels of metabolites, it found that ABS had higher toxicity, as particles collected further from the printer caused more damage to viability.

In light of their findings, the researchers arent calling for anything too drastic, like reviewing the 3D printing of ABS or PLA in STEM settings. Instead, the duo say issues like proximity and opportunities to disperse harmful fumes should be discussed in machine safety guidance, to educate users on potential dangers.

ABS filament emissions may be more biologically active than PLA, the team say in their paper. Although contaminants were found at the high school site, ABS filament emissions and associated exposures contributed to a significant decline in small airway epithelial viability, oxidative stress, an increase in double stranded DNA breaks, and high levels of the metabolites associated with cellular injury.

AM emissions: a growing field of research

While its relatively well-known that the fumes emitted by certain materials during 3D printing could be harmful, the extent of this danger still isnt fully understood. Just last year, fume and particle extraction technology developer BOFA International emission research revealed the impact of particulates and gasses emitted, and suggested measures users can take to protect themselves from harm.

Scientists at the US Environmental Protection Agency (EPA) have also previously tried to assess the impact of 3D printing ABS that has been reinforced with carbon nanofibers. Through its 3D printing emission study, the agency sought to develop fresh literature on the topic, designed to help users understand potential issues.

In the past, Underwriters Laboratories itself has published UL standards for 3D printing emissions, to enable manufacturers to mitigate any indoor air pollution risks. Back in 2019, the organization issued ANSI/CAN/UL 2904, a document its VP of Standards Philip Piqueira said would advance the availability of low-emission printers and print media for use in the global marketplace.

Nominations for the 2022 3D Printing Industry Awards are now open. Who do you think should make the shortlists for this years show? Let us know by casting your vote now.

To stay up to date with the latest 3D printing news, dont forget to subscribe to the 3D Printing Industry newsletter or follow us on Twitter or liking our page on Facebook.

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Featured image shows researchers working at Underwriters Laboratories CIRI institute. Photo via Underwriters Laboratories.

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The Alliance for Regenerative Medicine Announces Election of 2023 Officers, Executive Committee, and Board of Directors – GlobeNewswire

Posted: October 13, 2022 at 2:31 am

Carlsbad, CA, Oct. 11, 2022 (GLOBE NEWSWIRE) -- The Alliance for Regenerative Medicine (ARM), the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies, today announced the election of its 2023 Officers, Executive Committee, and Board of Directors.

The announcement comes as ARM kicks off its 2022 Cell & Gene Meeting on the Mesa, a gathering of 1,800 leaders in the cell and gene therapy sector.

The Executive Committee and Board of Directors oversee the formation and execution of ARMs strategic priorities and focus areas. These distinguished leaders are instrumental to ARMs leadership of the sector.

We are delighted to welcome our 2023 Officers, Executive Committee members and Board of Directors, said ARMs Chief Executive Officer Timothy D. Hunt. The pipeline of transformative cell and gene therapies will continue to accelerate in 2023, creating more urgency to ensure that patients have access to life-changing medicines. ARMs Board of Directors and our more than 450 member organizations globally are vital to this mission.

ARM 2023 Officers:

Devyn Smith, Ph.D. Chief Executive Officer, Arbor Biotechnologies (Chair)

Dave Lennon, Ph.D. Chief Executive Officer, Satellite Bio (Vice Chair)

Alison Moore, Ph.D. Chief Technology Officer, Allogene Therapeutics (Secretary)

Chris Vann Senior Vice President, Chief Operations Officer, Autolus (Treasurer)

ARM 2023 Executive Committee:

Devyn Smith, Ph.D. Chief Executive Officer, Arbor Biotechnologies (Chair)

Dave Lennon, Ph.D. Chief Executive Officer, Satellite Bio (Vice Chair)

Alison Moore, Ph.D. Chief Technology Officer, Allogene Therapeutics (Secretary)

Chris Vann Senior Vice President, Chief Operations Officer, Autolus (Treasurer)

Bob Smith, MBA Senior Vice President, Global Gene Therapy Business, Pfizer

Miguel Forte, M.D., Ph.D. Chief Executive Officer, Bone Therapeutics

Laura Sepp-Lorenzino, Ph.D. Executive Vice President and Chief Science Officer, Intellia Therapeutics

Arthur Tzianabos, Ph.D. Chair of the Board, Homology Medicines

ARM 2023 Board of Directors

* New to the Board for 2023

* Faraz Ali, MBA Chief Executive Officer, Tenaya Therapeutics

Robert Ang, MBBS, MBA Chief Executive Officer, Vor Biopharma

* Catherine Bollard, M.B.Ch.B., M.D. Director of the Center for Cancer and Immunology Research, Childrens National Hospital and The George Washington University

Amy Butler, Ph.D. President, Biosciences, Thermo Fisher

Bradley Campbell, MBA President and Chief Executive Officer, Amicus Tx

Miguel Forte, M.D., Ph.D. Chief Executive Officer, Bone Therapeutics

* Christine Fox President, Novartis Gene Therapies

Bobby Gaspar, M.D., PhD. Chief Executive Officer, Orchard Therapeutics

Jerry Keybl, Ph.D. Senior Director, Cell & Gene Therapy, MilliporeSigma

Brett Kopelan Executive Director, Debra of America

* Ann Lee, Ph.D. Chief Technical Officer, Prime Medicine

Dave Lennon, Ph.D. Chief Executive Officer, Satellite Bio

Tim Lu, M.D., Ph.D. Chief Executive Officer and Co-Founder, Senti Biosciences

John Maslowski, M.S. Chief Commercial Officer, Forge Biologics

Chris Mason, M.D., Ph.D. Founder & Director, Ori Biotech

Debra Miller Founder & Chief Executive Officer, CureDuchenne

Alison Moore, Ph.D. Chief Technology Officer, Allogene

Adora Ndu, PharmD, J.D. Chief Regulatory Officer, BridgeBio

Susan Nichols President & Chief Executive Officer, Propel BioSciences

Emile Nuwaysir, Ph.D. Chief Executive Officer, Ensoma

Karah Parschauer, J.D. Chief Legal Officer, Ultragenyx

* Jacob Petersen Corporate Vice President and Head of Stem Cell Research & Development, Novo Nordisk

Louise Rodino-Klapac, Ph.D. Executive Vice President, Head of Research & Development, Chief Scientific Officer, Sarepta Therapeutics

Jeff Ross, Ph.D. Chief Executive Officer, Miromatrix Medical

* Alberto Santagostino Senior Vice President, Head of Cell & Gene Technologies, Lonza

Laura Sepp-Lorenzino, Ph.D. Executive Vice President & Chief Scientific Officer, Intellia Therapeutics

R.A. Session, MBA, MSF President, Founder & Chief Executive Officer, Taysha Tx

Curran Simpson, M.S. Chief Operations and Chief Technical Officer, REGENXBIO

Bob Smith, MBA Senior Vice President, Global Gene Therapy, Pfizer

Devyn Smith, Ph.D. Chief Executive Officer, Arbor Biotechnologies

Arthur Tzianabos, Ph.D. Chair of the Board, Homology Medicines

Christopher Vann Senior Vice President & Chief Operating Officer, Autolus Therapeutics

Kristin Yarema, Ph.D. Chief Commercial Officer, Atara Bio

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Husband and Wife Team Bring Regenerative Medicine Clinic to Jackson – Franchising.com

Posted: October 13, 2022 at 2:31 am

By: QC Kinetix | 0Shares 159Reads

October 10, 2022 // Franchising.com // JACKSON, Tenn. - QC Kinetix recently opened in Jackson and offers one of the most advanced regenerative medicine protocols in Western Tennessee.

Brian and Andrea Weed are the husband-and-wife business team bringing regenerative medicine to Jackson with their new clinic. The couple used to work in healthcare on the non-clinical side of the industry - Brian as the CEO and Andrea in sales. Now the two are looking to help improve lives through regenerative medicine. They have three sons: one having been in combat in the Afghanistan war and two who played college sports. All have sustained an injury or two.

We have seen our fair share of sports injuries and we know the toll physically and emotionally it takes on when they are forced to take time off, says Andrea. With regenerative medicine treatments, they can bounce back quicker.

The Weeds set up an exceptional team to treat the community, that includes their clinic manager Danielle Moore. Her background is in kinesiology, where she worked in physical therapy for several years and then in personal training before finding regenerative medicine.

I am always looking for ways to naturally treat ailments. When I found we can use our own body to repair itself through regenerative medicine I knew I needed to bring awareness to it, says Moore. We are already having patients who say they are feeling better compared to the first day they walked through our clinics doors.

QC Kinetix uses all-natural biologic protocols to stimulate the body to repair or heal its own damaged tissues and joints. Its an alternative to surgery, NSAIDs, and pain pills that mask the pain but dont repair the problem. For patients seeking relief from pain due to musculoskeletal injury, chronic joint pain, or hip, knee, back, or shoulder pain, regenerative procedures are the next frontier for treatment.

Former Dallas Cowboys great and NFL MVP Emmitt Smith is the official spokesperson for QC Kinetix. He knows firsthand the need for innovative chronic pain treatments that help people get back to their active lifestyles. It used to be only elite athletes like Smith had access to regenerative medicine treatments, but rapid growth and innovation in the field have made the treatments accessible to everyone.

So many Jackson residents will benefit from these treatments, from those who have retired to anyone enjoying an active lifestyle, as well as athletes and industry workers who cant afford a long surgery recovery, says Weed.

Regenerative medicine can be used to address a wide variety of health conditions. The Weeds and their team are excited to begin providing hair restoration treatment options for men and women in the near future.

Scott Hoots, CEO of Charlotte-based QC Kinetix, is confident that the Weeds and their team will be a tremendous asset to the QC Kinetix franchise.

Brian and Andrea are ideal QC Kinetix franchisees, says Hoots. Their background in business and sports combined with their love of regenerative medicine makes the Weeds a perfect candidate for us. We cant wait to see their business grow, and more Western Tennessee residents see the benefits of these treatments firsthand.

QC Kinetix is a type of concierge medicine, which continues to grow in popularity. There are none of the difficulties of dealing with insurance companies. Patients pay cash and get a very high level of care and service with state-of-the-art treatments. Every patient receives quality time with their medical provider and a customized plan of treatment based on their individual diagnosis and condition.

QC Kinetix Jackson operates at 3014 Greystone Square, Jackson, TN 38305.

SOURCE QC Kinetix

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Hundreds run for regenerative medicine research at the 2022 TCS London Marathon – British Heart Foundation

Posted: October 13, 2022 at 2:31 am

Around 800 BHF runners took to the streets of the British capitalfor the iconic 2022 TCS London Marathon on Sunday 2nd October.

As the 2022 Charity of the Year, our runners have raised nearly 2 million so far, with further donations expected. This will help fund lifesaving science into regenerative medicine, a cutting-edge field of research that has the power to unlock a cure for heart failure.

Among ourmarathon runners was Professor Sanjay Sinha from the University of Cambridge, who completed the event in around four hours fifty minutes.

Professor Sanjay is leading ground-breaking research behind the Heart Healing Patch. Made of stem cells, the patch could be applied to the heart to help repair damage caused by a heart attack and could help save and improve the lives of millions worldwide affected by heart failure.

Nearly a million people in the UK are currently living with heart failure. Poignantly, Sanjays running number for the marathon was 17,000 which is how many people are diagnosed with heart failure in the UK each month.

After crossing the finish line Professor Sanjay Sinha, our Senior Clinical Research Fellow at the University of Cambridge, said: Taking part in the 2022 TCS London Marathon for the British Heart Foundation (BHF), was such a huge challenge. It was my first marathon and an absolutely incredible experience. The atmosphere on the day was electric and I wouldnt have made it round the last few miles without the support from the crowds, who were amazing.

"I am proud to know that by doing this, together with over 800 other BHF runners, weve helped the BHF to continue to fund pioneering research into regenerative medicine including the development of our Heart Healing Patch, which could save and improve the lives of millions of people worldwide affected by heart failure.

The money raised by the BHFs runners and supporters at this years event could be truly transformative and help us carry out the first clinical trials of the patch in patients. I want to thank every single person who has already donated.

Our Chief Executive Dr Charmaine Griffiths said: It was a truly heart-warming and inspirational day cheering on all our Team BHF runners, made even more special with the BHF being the 2022 TCS London Marathons charity of the year.

The hundreds of runners who took part in the iconic TCS London Marathon 2022 have helped us to turbo charge our pioneering research into regenerative medicine, which includes the development of a Heart Healing Patch, which could save and improve the lives of millions of people worldwide affected by heart failure.

From all those who fundraised, donated, volunteered and supported Team BHF on the day, you have played your part in helping to get our ground-breaking research over the finish line even faster and we cannot thank you enough.

Applications for the 2023TCS London Marathon are now open.

Help to make the Heart Healing Patch a reality

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Frequency Therapeutics Completes Enrollment of Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss – Yahoo Finance

Posted: October 13, 2022 at 2:31 am

Study of Therapeutic to Restore Hearing Aims to Show Speech Perception Improvements in Individuals with Noise-Induced or Permanent Sudden Sensorineural Hearing Loss

Company Aligned with FDA on Speech Perception Primary Endpoint

Readout Expected in Q1 2023

LEXINGTON, Mass., October 12, 2022--(BUSINESS WIRE)--Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a persons innate potential to restore function, today announced that it has completed enrollment of its placebo-controlled Phase 2b study of FX-322 in adults with acquired sensorineural hearing loss (SNHL). The FX-322-208 study, which enrolled 142 individuals, is designed to show improvement in a pre-specified measure of speech perception. The Company plans to release study data in the first quarter of 2023.

"I am very pleased with our teams execution of this study for the first potential treatment to restore hearing for those with SNHL. The 208 study was rigorously designed to ensure the stability of an individuals hearing prior to entering the trial and to exclusively enroll those with the types hearing loss where we observed the strongest hearing improvement in prior FX-322 studies. FX-322 continues to have a favorable safety profile and we are aligned with FDA on the primary speech perception endpoint. With a successful outcome of this single-dose study, our intent is to advance the program into Phase 3 trials," said David L. Lucchino, Frequencys chief executive officer.

Mr. Lucchino continued: "We are grateful to all the study volunteers, clinicians and site staff for their time and commitment to this trial. We believe the high level of interest from patients and healthcare providers in this study further demonstrates the need for a novel, disease modifying hearing loss treatment to expand the standard of care for the millions of individuals with sensorineural hearing loss."

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FX-322-208 Study Design

FX-322-208 is a prospective, randomized, double-blinded, placebo-controlled, multi-center Phase 2b study designed to evaluate the efficacy of a single administration of FX-322 on speech perception in subjects aged 18-65 with hearing loss associated with either noise-induced or permanent idiopathic sudden SNHL. The study enrolled 142 participants, exceeding the original enrollment target of approximately 124, and is being conducted at 28 clinical sites across the US.

The Company previously aligned with the US Food and Drug Administration (FDA) on the use of the specific speech perception primary endpoint. With improved speech perception, individuals may hear words more clearly, a critical unmet need for individuals with hearing loss. The FX-322-208 study is powered at 80% (significance level of 0.05) to observe a statistically significant and clinically meaningful improvement in speech perception at day 90 following dosing, with study responders defined as individuals exceeding the upper 95% confidence interval in the speech perception test. The Company has not publicly disclosed the specific test used for the primary endpoint to maximize the rigor of the study and mitigate potential bias.

During the study, subjects participate in a range of audiologic exams, including pure-tone audiometry, word recognition in quiet, word recognition in noise, the Tinnitus Functional Index (TFI), as well as multiple patient-reported outcome measures including Frequencys proprietary patient reported outcome instrument (RADIAL) in acquired SNHL. All subjects are required to have a documented audiogram from at least six months prior to screening and most patients are evaluated over a 270-day period following dosing. The studys rigorous design includes a lead-in phase with multiple baseline measures. Subjects with instability of baseline tests are disqualified from participation in the study. Study audiometry testing sessions are recorded and monitored by third party audiologists to ensure consistency and identify any anomalies related to how tests were conducted.

In prior studies, the Company observed the greatest concentration of speech perception improvements in individuals with permanent sudden or noise-induced sensorineural hearing loss in the moderate to lower severe hearing loss range. These learnings informed the design and inclusion criteria for the FX-322-208 study. More than 200 individuals have been dosed with a single injection of FX-322 in prior or ongoing studies, and the drug candidate has continued to exhibit a favorable safety profile with no drug-related serious adverse events.

About Sensorineural Hearing Loss

Sensorineural hearing loss is the most common form of hearing loss, typically resulting from damage to sensory hair cells in the cochlea. These cells convert sound waves to signals sent to the brain which are interpreted as speech and sound. Sensory hair cells are lost due to chronic noise exposure, aging, certain viral infections or exposure to drugs that are toxic to the ear. This type of hearing loss impacts around 40 million individuals in the U.S. alone.

About Frequency Therapeutics

Frequency Therapeutics is leading a new category in regenerative medicine that aims to restore human function first in hearing loss and then in multiple sclerosis by developing therapeutics that activate a persons innate regenerative potential within the body through the activation of progenitor cells. Frequencys hearing research focuses on cochlear restoration and auditory repair, and its lead asset, FX-322, is a small-molecule combination product candidate that is the first to show statistically significant and clinically meaningful hearing improvements in clinical trials for sensorineural hearing loss. Frequency is also following early restorative signals in MS to develop medicines with the same underlying regenerative science being brought to hearing loss.

Headquartered in Lexington, Mass., Frequency has an ex-U.S. license and collaboration agreement with Astellas Pharma Inc. for FX-322, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, and the Scripps Research Institute.

For more information, visit http://www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the timing and design of the Phase 2b study (FX-322-208), including the timing of results and the ability of design features to reduce bias, the commencement of any future FX-322 trials, the interpretation and implications of the results and learnings of other FX-322 clinical studies, the treatment potential of FX-322, estimates of the size of the hearing loss population, the acceptance by the FDA of particular endpoints in the Companys trials, and the potential application of the progenitor cell activation (PCA) platform to other diseases.

These forward-looking statements are based on managements current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of COVID-19 on the Companys ongoing and planned clinical trials, research and development and manufacturing activities, the Companys business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Companys need for additional funding to complete development and commercialization of any product candidate; the Companys dependence on the development of FX-322; the unproven approach of the PCA platform and the inability to identify additional potential product candidates; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; the Companys limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; ability to seek and receive Breakthrough Therapy designation for FX-322; the Companys ability to enroll and retain patients in clinical trials; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with changing laws and regulations, including healthcare and environmental, health, data privacy and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property rights covering product candidates; security breaches or failure to protect private personal information; attracting and retaining key personnel; and the Companys ability to manage growth.

These and other important factors discussed under the caption "Risk factors" in the Companys Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 9, 2022 and its other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent managements estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Companys views as of any date subsequent to the date of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221012005144/en/

Contacts

Investor:Carlo Tanzi, Ph.D.Kendall Investor Relationsctanzi@kendallir.com 617-914-0008

Media:Frequency TherapeuticsEmail: media@frequencytx.com

See original here:
Frequency Therapeutics Completes Enrollment of Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss - Yahoo Finance

Posted in Regenerative Medicine | Comments Off on Frequency Therapeutics Completes Enrollment of Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss – Yahoo Finance

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