Category Archives: Stem Cell Therapy

WASHINGTON, DC--(Marketwire - Oct 17, 2012) - The Alliance for Regenerative Medicine (ARM), the international organization representing the interests of the regenerative medicine community, announced the publication today of an article on FDA communications to help companies developing cell-based therapies by clarifying the development pathway. The article, entitled "Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" will be published in the journal Stem Cells Translational Medicine. It is co-authored by representatives from ARM, Janssen R&D, GE Healthcare and Life Technologies, with the lead author from the California Institute for Regenerative Medicine (CIRM).

"There are a number of ways cell-based therapy companies can communicate with FDA that will help them navigate the road from the bench to a regulatory submission," said Michael Werner, Executive Director of ARM. "We hope that our combined experience as co-authors, and our attempt to create a single source of guidance on the regulatory process, will help companies bring new cell-based therapies through clinical trials and the regulatory review process more quickly so they can reach patients faster," added Mr. Werner.

Lead author Ellen Feigal, MD, Senior Vice President for Research and Development at the California Institute for Regenerative Medicine (CIRM) commented, "Cell-based therapies represent a fundamentally new way to treat or cure disease, but developing a new therapy is costly, time consuming and fraught with uncertainty. Our paper takes a practical approach to clarifying the path to market."

"Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" provides detailed information on options for communicating with the FDA at different stages; the official communications tied to each stage of development; and the most common reasons regulatory applications are delayed. The article can be accessed at: http://stemcellstm.alphamedpress.org/content/early/recent

About CIRM: CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. A list of grants and loans awarded to date may be seen here: http://www.cirm.ca.gov/for-researchers/researchfunding.

About ARM: The Alliance for Regenerative Medicine is a Washington, DC-based multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, DC to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today ARM has more than 120 members and is the leading global advocacy organization in this field. In March 2012, ARM launched a sister organization in Europe -- the Alliance for Advanced Therapies. For more information go to http://www.alliancerm.org.

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Journal Stem Cell Translational Medicine to Publish Article on FDA Communications and the Regulatory Pathway for Cell ...

Grants Pass, OR (PRWEB) October 16, 2012

Harvard Ophthalmologist and Corneal Stem Cell Researcher Ula Jurkunas, MD, has announced an important new stem cell transplant procedure for the eyes.

Speaking on the Sharon Kleyne Hour Power of Water radio show, Dr. Jurkunas, predicted that the procedure will offer a significant benefit to patients with certain corneal diseases, and corneal injuries such as chemical and thermal burns (The cornea is the eyes clear portion).

Stem cell research has been in the news because the 2012 Nobel Prize for Medicine was awarded for stem cell research.

Dr. Jurkunas explained to host Sharon Kleyne that the human eye produces its own adult (non-embryonic) stem cells. These are found between the limbus (where the clear cornea meets the white of the eye) and the conjunctiva (the red meaty tissue in the eyes inner corner). Their function is to replenish corneal cells to keep the cornea clear and healthy.

Production of corneal stem cells, according to Dr. Jurkunas, can become impaired due to a disease entity such as an infection, severe allergy, severe dry eye, immunological disorder or chronic inflammation; or due to injury such as a chemical or thermal burn. These traumas can cause the cornea to become cloudy and ulcerated. Prior to the present corneal stem cell research, there had been no reliable, non-invasive treatment for these conditions.

Corneal stem cell transplantation, Dr. Jurkunas explains, has the advantage of utilizing the patients own tissue as donor cells. Stem cells may be taken either from healthy tissue elsewhere in the diseased eye, from the patients other eye, or from the patients inner cheek (which has many similarities to eye tissue and also produces adult stem cells). Donor stem cells are then isolated and grown in culture. The final step is to transfer them to the affected cornea using a stem cell bandage.

The procedure, says Dr. Jurkunas, has resulted in dramatic corneal clearing and sight restoration. Although research is ongoing and the procedure remains experimental, corneal stem cell therapy is available in clinical trials. Widespread applications of the procedure, including routine testing for corneal stem cell deficiency, are anticipated. Stem cell therapy, according to Dr. Jurkunas, could eventually be used for macular degeneration, glaucoma and other eye diseases.

Dr. Jurkunas stressed the importance of water and hydration in maintaining a healthy tear film and cornea. The tear film covering the cornea is 99% water and is essential to the light refraction that enables vision. Dry eye and related eye infections, according to Dr. Jurkunas, can damage both the cornea and adjacent stem cell producing tissues that enable the cornea to repair itself. Water in the tear film stimulates the healthy production of stem cells. Water is also critical to keeping stem cells viable during transplantation.

Mrs. Kleyne and Dr. Jurkunas agree that non-invasive therapies using the bodys own tissues, such as corneal stem cell transplantation, could eventually prove indispensable in combating the worldwide health effects of global drying and dehydration.

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Harvard Ophthalmologist Dr. Ula Jurkunas Introduces Stem Cell Transplant for Eyes

With all the publicity about the miraculous effects of stem cell therapy, the Department of Health (DOH) should prepare itself for the possibility that the new procedure would be performed by unqualified, and completely clueless, people.

I passed a beauty parlor recently and saw a huge poster on its door announcing the arrival of stem cell therapy. I was instantly reminded of botched breast enhancement and nose jobs performed by salon personnel who seemed to think it was as easy to learn complicated surgical procedures as it was to train to cut hair or do manicures and pedicures.

The DOH should start warning the public not to fall for these special offers just because they are available at giveaway rates.

Modern lifestyle problem

Experts have repeatedly talked about problems brought about by modern lifestyles. Changing diets and stress are two of the best known. Dr. Jaime G. Ignacio, section chief of gastroenterology at Veterans Hospital and head of the Digestive Malignancy Council of the Philippine Society of Gastroenterology, said constipation could be one of the consequences of the combination of these two factors.

Speaking at an event hosted by Boehringer Ingelheim, maker of Dulcolax (generic name Bisacodyl), a formulation for constipation relief, Ignacio, who, as a gastroenterologist is a specialist in digestive system disorders, defined the problem as having fewer than three bowel movements in a week (normal ranges from three times a week to three times a day).

He said constipation itself was not a disease but it could sometimes be a symptom of something serious, like colorectal cancer. But he said about 95 percent of cases were acuteoccurring suddenly and lasting for only a short periodresulting from some sudden lifestyle or hormonal changes, the taking of medication, lack of exercise, etc.

Ignacio said acute was easy to treat, with products like Dulcolax to solve the problem. But, if left unattended, acute constipation could lead to a chronic or long-term condition, which was the more worrisome, and would need medical attention.

He said constipation should be treated as soon as the problem had lasted for four or more days.

Constipation is part of modern living. [Like other diseases] prevention is the key. Safe and effective treatment is available [if needed], Ignacio stressed.

Originally posted here:
Beauty salon ‘offers’ stem cell therapy

LONDON (ShareCast) - ReNeuron has reported further progress in the clinical trial of its ReN001 stem cell therapy for disabled stroke patients, known as the PISCES study.

The third and penultimate batch of three patients have all been successfully treated with ReN001 and discharged from hospital with no acute safety issues arising. This follows approval last month by the independent Data Safety Monitoring Board (DSMB) for the study to proceed to completion of dosing of this batch of patients.

The PISCES study continues to run to plan, with no cell-related serious adverse events reported in any of the patients treated to date, the clinical-stage stem cell specialist reported. The remaining three, high-dose cohort patients to be treated in the PISCES study have been identified and evaluated as potentially eligible for treatment, with patient enquiries continuing to come into the Glasgow clinical site and a number of patients consequently identified as reserve candidates for the study. Subject to DSMB approval, these final three patients are scheduled to be treated in January and March 2013.

In June of this year, interim data from the PISCES study from the first five patients treated was presented by the Glasgow clinical team at the 10th Annual Meeting of the International Society for Stem Cell Research (ISSCR) in Yokohama, Japan (EUREX: FMJP.EX - news) . Reductions in neurological impairment and spasticity were observed in all five patients compared with their stable pre-treatment baseline performance and these improvements were sustained in longer term follow-up.

Based on the above progress, the company announced last month that, ahead of plan, it had submitted an application to the UK regulatory authority to commence a multi-site Phase II clinical trial to examine the efficacy of ReN001 in patients disabled by an ischaemic stroke.

This trial is designed to recruit from a well-defined population of patients between two and four months after their stroke, which the company and its clinical collaborators currently believe will be the optimum treatment window for the therapy. Subject to continuing positive progress with the PISCES study, and subject to regulatory and ethical approvals, the company hopes to be able to commence the Phase II stroke study in mid-2013. The proposed study is expected to take up to 18 months to complete.

ReNeuron's ReN001 stem cell therapy is being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition.

This news should also have positive read-across for Aim-listed Angel Biotechnology (Berlin: A3G.BE - news) , which supplies the stem cells used in the study.

CM

Originally posted here:
ReNeuron progresses stroke clinical trial

With all the publicity about the miraculous effects of stem cell therapy, the Department of Health (DOH) should prepare itself for the possibility that the new procedure would be performed by unqualified, and completely clueless, people.

I passed a beauty parlor recently and saw a huge poster on its door announcing the arrival of stem cell therapy. I was instantly reminded of botched breast enhancement and nose jobs performed by salon personnel who seemed to think it was as easy to learn complicated surgical procedures as it was to train to cut hair or do manicures and pedicures.

The DOH should start warning the public not to fall for these special offers just because they are available at giveaway rates.

Modern lifestyle problem

Experts have repeatedly talked about problems brought about by modern lifestyles. Changing diets and stress are two of the best known. Dr. Jaime G. Ignacio, section chief of gastroenterology at Veterans Hospital and head of the Digestive Malignancy Council of the Philippine Society of Gastroenterology, said constipation could be one of the consequences of the combination of these two factors.

Speaking at an event hosted by Boehringer Ingelheim, maker of Dulcolax (generic name Bisacodyl), a formulation for constipation relief, Ignacio, who, as a gastroenterologist is a specialist in digestive system disorders, defined the problem as having fewer than three bowel movements in a week (normal ranges from three times a week to three times a day).

He said constipation itself was not a disease but it could sometimes be a symptom of something serious, like colorectal cancer. But he said about 95 percent of cases were acuteoccurring suddenly and lasting for only a short periodresulting from some sudden lifestyle or hormonal changes, the taking of medication, lack of exercise, etc.

Ignacio said acute was easy to treat, with products like Dulcolax to solve the problem. But, if left unattended, acute constipation could lead to a chronic or long-term condition, which was the more worrisome, and would need medical attention.

He said constipation should be treated as soon as the problem had lasted for four or more days.

Constipation is part of modern living. [Like other diseases] prevention is the key. Safe and effective treatment is available [if needed], Ignacio stressed.

Continued here:
Beauty salon ‘offers’ stem cell therapy