NewsLife: DOH calls for registration of stem cell therapy operators
NewsLife - DOH calls for registration of stem cell therapy operators (Reported By: Noel Perfecto) - [August 12, 2013] For more news, visit: #9659;http://www.ptvne...
By: PTV PH
View post:
NewsLife: DOH calls for registration of stem cell therapy operators - Video
NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--
BrainStorm Cell Therapeutics Inc. (BCLI), leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that it will hold a conference call on Tuesday, August 20, 2013 at 8:45 a.m. Eastern Daylight Time, 15:45 Israel Daylight Time. Mr. Chaim Lebovits, President and Principal Executive Officer, will update shareholders on the recent public offering and other company developments. The call will be conducted in English, with Q&A in both English and Hebrew.
Callers may participate in the conference call by dialing:
USA:1-888-407-2553 Israel: 03-918-0644 International:+972-3-918-0644
Callers are invited to ask relevant questions in English or Hebrew during the conference call. Questions may also be pre-submitted toinfo@brainstorm-cell.com prior to 7:00 a.m. EDT on Monday, August 19, 2013.
A recording of the conference will be available for download Wednesday, August 21, 2013 from the companys website.
About BrainStorm Cell Therapeutics, Inc.
BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. For more information, visit the companys website at http://www.brainstorm-cell.com.
Safe Harbor Statement
Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as may, should, would, could, will, expect, likely, believe, plan, estimate, predict, potential, and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorms forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or managements beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
The rest is here:
BrainStorm Cell Therapeutics Will Host a Conference Call to Update Shareholders on Recent Company Developments
NEW YORK, Aug. 14, 2013 /PRNewswire/ --The Tisch MS Research Center of New York announced today that it has received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) to commence a Phase 1 trial using autologous neural stem cells in the treatment of multiple sclerosis (MS). MS is a chronic human autoimmune disease of the central nervous system that leads to myelin damage and neurodegeneration and affects approximately 2.1 million people worldwide.
"To my knowledge, this is the first FDA-approved stem cell trial in the United States to investigate direct injection of stem cells into the cerebrospinal fluid of MS patients, and represents an exciting advance in MS research and treatment," said Dr. Saud A. Sadiq, Senior Research Scientist at Tisch MS Research Center of New York and the study's principal investigator.
The groundbreaking study will investigate a regenerative strategy using stem cells harvested from the patient's own bone marrow. These stem cells will be injected intrathecally (into the cerebrospinal fluid surrounding the spinal cord) in 20 participants who meet the inclusion criteria for the trial. This will be an open label safety and tolerability study. All study activities will be conducted at the Tisch MS Research Center and affiliated International Multiple Sclerosis Management Practice (IMSMP).
The clinical application of autologous neural progenitors in MS is the culmination of a decade of stem cell research conducted by a dedicated team of scientists headed by Dr. Sadiq and by Dr. Violaine Harris, Research Scientist at Tisch MS Research Center.
Preclinical testing found that the injection of these cells may decrease brain inflammation and promote myelin repair and/or neuroprotection. "This study exemplifies the Tisch MS Research Center's dedication to translational research and provides a hope that established disability may be reversed in MS," Dr. Sadiq noted.
Participants will undergo a single bone marrow collection procedure, from which mesenchymal stem cell-derived neural progenitor cells (MSC-NPs) will be isolated, expanded and tested prior to injection.Participants will receive three rounds of injections at three month intervals. Safety and efficacy parameters will be evaluated in all participants through regular follow-up visits.
For more information on this study visit: http://www.tischms.org
ABOUT TISCH MS RESEARCH CENTER OF NEW YORK For over twenty years, Dr. Saud A. Sadiq has believed that combining excellence in clinical care with innovative research targeted at finding the cure for multiple sclerosis would set an exemplary standard in the treatment of MS patients. Today, the Tisch MS Research Center of New York embodies this new model of healthcare, in which your doctor is also your researcher. Dr. Sadiq helps those with MS by conducting cutting-edge, patient-based research to ensure unparalleled care. The close relationship of the non-profit research center and its affiliated clinical practice (International Multiple Sclerosis Management Practice) enables the testing of new MS treatments and accelerates the pace at which research discoveries move from lab bench to bedside. The Tisch MS Research Center of New York aims to identify the disease trigger, optimize treatments for patients, and repair the damage caused by multiple sclerosis.
Read the original here:
FDA Approves Stem Cell Clinical Trial For Multiple Sclerosis
By: Jet Villa, InterAksyon.com August 13, 2013 8:42 AM
InterAksyon.com The online news portal of TV5
MANILA, Philippines - The Department of Health (DOH) has given all health facilities practicing stem cell therapy and companies importing and producing stem cell products untilAug. 31to apply for accreditation and product registration, respectively.
Nick Lutero, director of the DOH-Bureau of Health Facilities and Services, said it will be considered illegal for facilities to do stem cell procedures if they fail to comply with the requirement.
Papatigil namin ang pag-conduct ng therapy. For those still continuing to practice, I think we have sufficient laws, particularly on the illegal practice of medicine. They could be criminally liable, he said in a chance interview.
Lutero lamented that only five hospitals have applied for registration although the DOH had issued the guidelines on this since March.
We have done preliminary visits sa mga hospitals na ito at mukang based sa initial inspection, merong sufficient compliance sa mga facilities, he said.
Companies importing and producing stem cell products, on the other hand, should apply for registration with the Food and Drug Administration, an agency attached to the DOH.
Products that will not be applied for registration will also be considered illegal after the deadline.
Experimental treatment not for free
Read the original here:
DOH gives health facilities engaged in stem cell therapy until Aug. 31 to register
Manila, Philippines -- Hospitals and health facilities offering stem cell therapy have until August 31 to apply for accreditation from the Department of Health (DoH).
DoH Secretary Enrique T. Ona said a number of hospitals in Metro Manila have already applied for accreditation to perform this "innovative" treatment that has not yet been accepted as standard mode of care in the country since it needs further tests and several more layers of research.
In the first mid-year convention of the Philippine Society for Stem Cell Medicine at the Manila Hotel yesterday, Ona reiterated that stem cell therapy is "the future of medicine."
"Stem cell therapy is not a cure-all medical treatment. Patients have yet to be presented first with standard of treatment, and in many cases, stem cell treatments have to be done in conjunction with other standard modalities of treatment," he said.
The Bureau of Health Facilities and Services (BHFS) of the DoH is accepting the applications for accreditation while a bio-ethics committee and a hospital-based review board will go over the applications and decide on their approval.
Five big hospitals in Metro Manila have already applied for accreditation, said Nick Lutero, chief of the BHFS.
Lutero said initial checks have revealed that these hospitals possess the required equipment needed for the treatment but they would still have to check on requirements set by the Food and Drug Administration (FDA) in relation to the practice.
Lutero said institutions that are offering stem cell treatments can still perform the procedures pending the approval of applications. However, once formal accreditations are already given, unaccredited institutions should cease offering stem cell therapy.
Continue reading here:
DOH sets deadline for stem cell therapy accreditation
TWENTY-TWO medical organizations pushing for the free stem cell treatment in the country on Tuesday got a shot in the arm as the co-chairperson of the Philippine Health Research Ethics Board (PHREB) expressed agreement to their position.
In a weekly forum in Quezon City, PHREB co-chairperson Dr. Marita Reyes said it is only right that the patient undergoing stem cell therapy will not be charged, especially since the amount involved is millions of pesos.
"The one who will carry the most risk should not be made to pay," opined Reyes.
Over the weekend, 22 medical organizations said that stem cell therapy should be given free based on ethical standards.
"When stem cell is given under a clinical study, it is unethical to make patients pay for the treatment. The cost of treatment should be shouldered by the sponsor of the study," said the organizations in their position paper.
However, Department of Health (DOH) Secretary Enrique Ona rejected this. Ona said, the country cannot afford to make service providers shoulder the cost of the stem cell treatment.
This was despite his admission that the government has yet to approve any type of stem cell treatment and that those practiced here can still be considered as "clinical trials."
According to Reyes, such a statement from the Health chief is just unfortunate.
"Sino ba ang may risk? Ang pasyente. Tapos siya pa ang magbabayad? Excuse me. Hindi ba medyo unjust naman yon," said Reyes.
Stem cell therapy is a type of intervention strategy that introduces new adult stem cells into damaged tissue in order to treat disease or injury and has recently seen growing popularity in the country. (HDT/Sunnex)
Read the original here:
Medical groups get support over bid for free stem cell
Manila, Philippines --- The Philippine College of Physicians (PCP) yesterday appealed to politicians and celebrities who have undergone the controversial stem cell therapy to stop promoting the procedure which has become a subject of debate for local medical practitioners.
"Pakiusap ko sa kanila, huwag na kayo magpagamit kasi mas malakas pa kayo sa Billboard," Dr. Tony Dans, president of the Philippine Society of General Internal Medicine (PSGIM) said at a forum in Quezon City yesterday.
Stem cell treatment is still in its experimental stages and is therefore not yet an accepted form of treatment in the country, the PCP leaders emphasized.
The group presented a slide containing photos of public figures who had reportedly undergone stem cell therapy.
One of the photos showed Manila Mayor Joseph Estrada who earlier revealed he underwent stem cell treatment in Germany in 2012 where he received stem cells from an unborn sheep.
"Sana huwag na lang siyang (Estrada) maging 'endorser' kasi madami siyang following baka sumunod sa kanya," said Dr. Anthony Leachon, Vice President of PCP.
The Department of Health (DOH) bans the use of stem cells gathered from animal and plant sources. The sources of stem cells allowed in the Philippines is the Autologous or Adult Stem Cells taken from the patient's own blood, bone marrow and fat.
View original post here:
Doctors hit stem cell promotion
Osiris Therapeutics Inc.s shares more than doubled after the regenerative-tissue company said a trial of its living stem cell treatment closed three times as many diabetic foot ulcers as standard care.
Osiris rose to $21.75 at 12:53 p.m. New York time, after earlier reaching $24.78 for the biggest intraday gain since the company first sold shares to public in August 2006.
Interim results from 97 patients in the study found 62 percent of those on Osiriss Grafix had their wound completely closed compared with 21 percent who received conventional treatment, the Columbia, Maryland-based company said today in a statement. Grafix is a flexible, conforming membrane that is applied directly to wounds. The trial also found the therapy also closed wounds faster.
Osiris has established a new standard in diabetic wound care and has demonstrated to the world the tremendous impact stem cell products can have in medicine, C. Randal Mills, chief executive officer, said in the statement. Diabetic foot ulcers afflict 25 percent of all diabetics and are responsible for more hospitalizations than any other diabetic complication.
The trial is discontinuing the blind phase of the study where its not revealed which patients are receiving which treatment. Patients who were receiving the standard of care will be offered treatment with Grafix, Osiris said.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
View post:
Osiris Doubles on Study Showing Grafix Closes Wounds
By Christian V. Esguerra Philippine Daily Inquirer
La Union Rep. Eufranio Eriguel. Photo from congress.gov.ph
MANILA, PhilippinesA congressman has joined the call to regulate stem cell therapy administered in the country.
La Union Rep. Eufranio Eriguel has introduced House Bill No. 212, which would put up a bioethics advisory board that would establish ethical standards governing the practice of stem cell research and therapy.
Under the proposed Stem Cell Research and Therapy Act of 2013, the board shall be responsible for addressing contentious ethical, scientific and legal issues in stem cell and cell-based or cellular research and therapies.
There is much to be learned from stem cell therapy, its benefits and application in the cure of some of the most devastating diseases and conditions. As of now, the full promise of stem cell treatment remains unknown, Eriguel said in a statement.
But the cost far outweighs its benefits because it is very expensive and only a few physicians are trained to do stem cell procedures here in the Philippines.
In his proposal, the board will be headed by the health secretary and the National Transplant Ethics Committee, while the Food and Drug Administration director will serve as vice chairman.
A proposed institutional review committee will be tasked to approve stem cell and cell-based or cellular research and therapies based on existing Department of Health guidelines.
Follow Us
COLUMBIA, Md.--(BUSINESS WIRE)--
Osiris Therapeutics, Inc. (OSIR), reported today that its multi-center, randomized, controlled clinical trial comparing the safety and effectiveness of Grafix to standard of care in patients with chronic diabetic foot ulcers had met the pre-specified stopping rules for overwhelming efficacy as determined by the data monitoring committee during a planned interim analysis. For the primary endpoint, 62% of patients receiving Grafix had complete wound closure compared to only 21% (p
The trial also reached statistical significance in favor of Grafix on all top-line secondary endpoints, demonstrating faster wound closure and a reduction in the number of treatments needed to achieve wound closure. In the crossover phase of the trial, patients whose wounds failed to close after 12 weeks of standard of care had an 80% closure rate when switched to Grafix. Importantly, patients randomized to receive standard of care were 74% more likely to experience an adverse event than those receiving Grafix (p=0.008). As a result, the blinded phase of the trial is being discontinued immediately and all patients randomized to the control arm will be offered treatment with Grafix.
Today, Osiris has established a new standard in diabetic wound care and has demonstrated to the world the tremendous impact stem cell products can have in medicine, said C. Randal Mills, Ph.D., Chief Executive Officer. Diabetic foot ulcers afflict 25% of all diabetics and are responsible for more hospitalizations than any other diabetic complication. With 25 million diabetics in the United States, the cost to our health care system is enormous. Through this rigorous study we have shown that Grafix can heal more patients, in less time, and with fewer complications.
Top-Line Data from the Interim Analysis of Protocol 302
(n=50)
(n=47)
These data are very compelling as we have not had a new cellular therapy for diabetic foot ulcers in over 10 years, said Dr. Larry Lavery, Principal Investigator and Professor of Plastic Surgery, University of Texas Southwestern Medical Center. Compared to other similarly designed studies, this trial demonstrates, by far, the largest relative improvement in complete wound closure. This is great news for our patients with diabetic foot ulcers that are at such high risk of losing their legs.
Grafix is a human cellular repair matrix that provides a high-quality source of living mesenchymal stem cells (MSCs). It is a flexible, conforming membrane that is applied directly to acute and chronic wounds.
We know now that an unfortunate consequence of diabetes is the pathological change that occurs with the number and functionality of certain stem cell populations necessary for optimal wound repair, said Michelle LeRoux Williams, Ph.D., Chief Scientific Officer. With Grafix, we are able to help correct this problem by providing patients with a rich source of healthy, non-controversial stem cells contained within a biologic matrix for easy delivery in the out-patient setting.
Read more from the original source:
Grafix® Demonstrates Overwhelming Efficacy in Landmark Stem Cell Study for the Treatment of Diabetic Foot Ulcers