Category Archives: Cell Therapy

A GROWING number of overseas clinics touting stem cell therapy for conditions ranging from sexual disorders to HIV are targeting Australia, where such treatments are restricted.

Australian scientists have raised concerns about so-called ''stem cell tourism'', saying many of the treatments offered are unproven, untested and potentially deadly.

The Swiss firm Fetal Cell Technologies International has been advertising in Australia since last year and Emcell, based in Ukraine, started promoting its services last month.

It is estimated as many as 200 Australians have travelled overseas for the therapy. The secretary for science policy at the Australian Academy of Science, Bob Williamson, said he empathised with the desperation of seriously ill people but warned against the unproven therapies, which can cost up to $60,000.

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''The therapies are almost all untested and unproven and sometimes they have killed people,'' Professor Williamson said. The Sun-Herald's calls to Emcell's Melbourne office were not returned.

Stem Cells Australia's Megan Munsie, who is conducting a study into stem cell tourism with Monash University, said many people she interviewed were unaware of the risks of therapy overseas.

''We're not talking about rubbing something into your skin or taking a capsule, we are talking about often a very invasive procedure,'' she said.

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Fears over 'stem cell tourism'

COLUMBIA, Md. (AP) -- Osiris Therapeutics Inc. said Monday it took a loss in the second quarter, but the company received the first two marketing approvals for its stem cell therapy Prochymal.

The company reported greater sales of its biosurgery products in the second quarter. However in the second quarter of 2011, Osiris turned a profit after recognizing more than $10 million in royalty payments and revenue from collaborative research and development agreements.

Osiris said it took a loss of $4.3 million, or 13 cents per share. A year ago it reported net income of $1.8 million, or 5 cents per share. Product revenue rose to $1.6 million from $130,000, but revenue from royalty payments and research and development collaborations declined to $98,000 from $10.2 million.

Analysts expected Osiris to report a loss of 15 cents per share and revenue of $1.6 million, according to FactSet.

Osiris said in May that Canadian regulators granted conditional approval to Prochymal. The therapy is used to treat graft vs. host disease, a condition in which transplanted bone marrow cells attack the body of the patient. Regulators in New Zealand gave full approval to Prochymal in June. The Food and Drug Administration has not approved Prochymal, but patients can get the treatment under certain conditions.

Almost all of Osiris' revenue in the latest quarter came from sales of stem cell biosurgery products like Grafix and Ovation. Grafix is applied to acute and chronic wounds like burns or diabetic foot ulcers to promote healing, and Ovation is used in orthopedic procedures.

The company also reported lower expenses for research and development and other costs.

Shares of Osiris Therapeutics fell 76 cents, or 7.6 percent, to $9.27 in morning trading.

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Osiris Therapeutics takes 2Q loss as payments fall

Details Published on Friday, 27 July 2012 00:00

STEM cell therapy is being eyed to cure the neck and back pains and other illnesses of former president and now Pampanga Rep. Gloria Arroyo, alternative medicine doctor Antonia Park said yesterday.

Arroyo went to Parks Green and Young Health and Wellness Center in Tagaytay City yesterday morning for cleansing and alternative healing.

A guard at the La Vista Subdivision in Quezon City, who requested anonymity, said Arroyo left the subdivision at around 7:30 a.m., accompanied by a few staff and a personal nurse. She rode a white Nissan Patrol and her convoy included a gray Toyota Land Cruiser and a police escort.

Arroyo was granted bail Wednesday by a Pasay City court after finding that the electoral sabotage case against her was weak. She posted a P1-million cash bond.

Stem cell treatment involves the introduction of new adult stem cells into the damaged tissue in order to treat a disease or injury. The ability of new cells to regenerate is seen as having significant potential to replace diseased areas of the body, with minimal risk of rejection and side effects.

Park, in a statement distributed to the media, said Arroyo complained of difficulty in swallowing with choking due to her bulge along the posterior pharyngeal wall, together with a change of her voice and losing weight due to her difficulties of swallowing the food (solid) and angina as well as continuous neck and back pain.

Thats why our center is accepting her for possible stem cell therapy and another treatment of pain management and giving natural food by means of fresh fruit and vegetable juices for which management is warranted and which the stem cell therapy is contemplated and strongly considered, she said.

She said the stem cell therapy can be given by her clinic in Tagaytay while Arroyo can continue her physical therapy at the Veterans Memorial Medical Center four times a week.

Park said Arroyo can to go her district, referring to the second district of Pampanga, over the weekend provided she takes care to wear a brace and avoid talking too much so as to protect the bulging interior of the throat, and provided she resumes physical therapy as soon as possible.

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Malaya Business Insight

Peter Aldhous, San Francisco bureau chief

It's official: stem cells are drugs. At least, that's the opinion of the US District Court in Washington DC, which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies.

Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice - not regulated by the US government. But if the cells are subjected to more than "minimal manipulation", the FDA maintains that the therapy becomes a "drug", which must be specifically approved for use.

Christopher Centeno, medical director of Regenerative Sciences, vows to appeal. "This is really round one," he says. "Our position remains that a patient's cells are not drugs."

Scott hopes that the FDA will now step up its efforts to regulate other clinics offering unproven stem cell therapies. These include Celltex of Sugar Land, Texas, which rose to prominence after Texas governor Rick Perry was injected with stem cells supplied by the company to aid his recovery from back surgery.

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Ruling frees FDA to crack down on stem cell clinics

A clinical trial of ALS patients conducted by BrainStorm Cell Therapeutics shows its adult stem cell therapy is well-tolerated, appears to be safe and does not present undue risk, according to an interim safety review.

Moreover, in some patients signs of stabilization of the disease were detected.

Israel-based BrainStorm is developing NurOwn for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's Disease, a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord.

"It's very uncommon to give at such an early point in a clinical study efficacy data, but we cannot ignore the fact on an individual basis we could see improvement in many of the patients involved, each one in different areas," Moshe Neuman, CEO of Biomedical Research Design, which serves as a contract research organization for the trial, said.

In some patients breathing improved, in others it was muscle strength and in others it was speech, he told Reuters.

Neuman said a final report was expected by the end of the year after each patient has been observed for nine months.

BrainStorm President Chaim Lebovits said the preliminary results demonstrate that the stem cells have the potential not only to stop deterioration but perhaps even cure ALS.

"The coming phases in the trial will have to prove this, but these results also reaffirm our belief that we have an enormous potential of being successful with less severe indications such as multiple sclerosis and Parkinson's," he said.

Patients in the trial were transplanted with stem cells derived from their own bone marrow and treated with the NurOwn stem cell technology.

The Phase I/II trial, designed to evaluate the safety and preliminary efficacy of BrainStorm's therapy, is being conducted at Jerusalem's Hadassah Medical Center. The company submitted the interim safety report to Israel's Health Ministry.

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Israel adult stem cell trials - hope for ALS patients?

NEW YORK & PETACH TIKVA, Israel--(BUSINESS WIRE)--BrainStorm Cell Therapeutics (OTC:BCLI) announced today that it has completed the planned interim safety review of its Phase I/II ALS (Amyotrophic Lateral Sclerosis) clinical trial, indicating that autologous transplantation of the Company's cell therapy was well-tolerated, appears to be safe for use, and did not present any undue risks to the study participants.

We are very encouraged by the positive results of our first cohort of 12 patients

We are very encouraged by the positive results of our first cohort of 12 patients, said Professor Dimitrios Karussis of the Neurology Department at Hadassah Medical Center Jerusalem and Principal Investigator of the trial. "This important safety and tolerability data are reassuring as we progress to the next half of this trial. Although this is an interim safety summary report documenting achievement of the study's primary endpoint, we cannot ignore some possible promising indications of clinical efficacy observed in single patients, such as a tendency towards improvement in some of the major ALS Functional Rating Scale variables.

The company is also happy to report that in some patients this pilot study demonstrated a tendency toward stabilization in some parameters in the ALS Functional Rating Scale.

The trial, which is designed to evaluate the safety and preliminary efficacy of BrainStorm's proprietary NurOwn cell therapy (bone marrow-derived, autologous, differentiated mesenchymal stromal cells) is being conducted at the Hadassah Medical Center in Jerusalem, Israel. The company submitted the positive interim safety report to the Israeli Ministry of Health.

The interim data was reported on the first group of patients, all of whom suffer from early stage or progressive ALS, also known as Lou Gehrig's disease. All patients enrolled were transplanted with NurOwn either intramuscularly or intrathecally.

Professor Robert Brown, Chair of Neurology at the University of Massachusetts Medical School and a world renowned expert in neuromuscular genetics and ALS, added, This interim report clearly documents that Brainstorms NurOwn stem cell therapy is safe. We are absolutely delighted that, with these data in hand, Brainstorm is now moving forward into expanded studies involving trials here in Boston, Massachusetts.

BrainStorm is conducting an important Phase I/II clinical trial to bring this potential therapy forward for patients with ALS, stated Professor Merit Cudkowicz, Chair of the Neurological Department at Massachusetts General Hospital and ALS expert. The safety results are a huge step in the right direction in finding the cure for ALS. The interim results demonstrate that Brainstorms NurOwn stem cell therapy at dosage tested is safe. The next steps are to explore additional dosages and a Phase II safety and preliminary efficacy study that we plan to assist indesigning. We look forward to working with BrainStorm on ALS, continued Professor Cudkowicz.

Dr. Adrian Harel, CEO of BrainStorm, commented, We are very pleased and excited with this interim safety report. Our Phase I/II human clinical trial represents the first time ever that autologous, bone marrow-derived, neurotrophic factor-secreting stem cells have been transplanted as a potential therapeutic agent for ALS.

Orphan-drug designation for NurOwn has been granted by the US Food and Drug Administration (FDA), and BrainStorm is awaiting FDA approval to expand its ALS clinical development to the United States. The Company has entered into a Memorandum of Understanding with the University of Massachusetts Medical School and Massachusetts General Hospital to begin ALS human clinical trials at these institutions.

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BrainStorm Reports Outstanding ALS Interim Clinical Trial Results

(Phys.org) -- New research at the Hebrew University of Jerusalem sheds light on pluripotencythe ability of embryonic stem cells to renew themselves indefinitely and to differentiate into all types of mature cells. Solving this problem, which is a major challenge in modern biology, could expedite the use of embryonic stem cells in cell therapy and regenerative medicine. If scientists can replicate the mechanisms that make pluripotency possible, they could create cells in the laboratory which could be implanted in humans to cure diseases characterized by cell death, such as Alzheimer's, Parkinson's, diabetes and other degenerative diseases.

To shed light on these processes, researchers in the lab of Dr. Eran Meshorer, in the Department of Genetics at the Hebrew Universitys Alexander Silberman Institute of Life Sciences, are combining molecular, microscopic and genomic approaches. Meshorer's team is focusing on epigenetic pathwayswhich cause biological changes without a corresponding change in the DNA sequencethat are specific to embryonic stem cells.

The molecular basis for epigenetic mechanisms is chromatin, which is comprised of a cell's DNA and structural and regulatory proteins. In groundbreaking research performed by Shai Melcer, a PhD student in the Meshorer lab, the mechanisms which support an open chromatin conformation in embryonic stem cells were examined. The researchers found that chromatin is less condensed in embryonic stem cells, allowing them the flexibility or "functional plasticity" to turn into any kind of cell.

A distinct pattern of chemical modifications of chromatin structural proteins (referred to as the acetylation and methylation of histones) enables a looser chromatin configuration in embryonic stem cells. During the early stages of differentiation, this pattern changes to facilitate chromatin compaction.

But even more interestingly, the authors found that a nuclear lamina protein, lamin A, is also a part of the secret. In all differentiated cell types, lamin A binds compacted domains of chromatin and anchors them to the cells nuclear envelope. Lamin A is absent from embryonic stem cells and this may enable the freer, more dynamic chromatin state in the cell nucleus. The authors believe that chromatin plasticity is tantamount to functional plasticity since chromatin is made up of DNA that includes all genes and codes for all proteins in any living cell. Understanding the mechanisms that regulate chromatin function will enable intelligent manipulations of embryonic stem cells in the future.

"If we can apply this new understanding about the mechanisms that give embryonic stem cells their plasticity, then we can increase or decrease the dynamics of the proteins that bind DNA and thereby increase or decrease the cells differentiation potential," concludes Dr. Meshorer. This could expedite the use of embryonic stem cells in cell therapy and regenerative medicine, by enabling the creation of cells in the laboratory which could be implanted in humans to cure diseases characterized by cell death, such as Alzheimer's, Parkinson's, diabetes and other degenerative diseases.

More information: The research appears in the journal Nature Communications as Melcer et al., Histone modifications and lamin A regulate chromatin protein dynamics in early embryonic stem cell differentiation. go.nature.com/9B33Ue

Journal reference: Nature Communications

Provided by Hebrew University of Jerusalem

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Researchers identify mechanisms that allow embryonic stem cells to become any cell in the human body