Stem Cell Clinic

Medistem Announces Patent Application on Stem Cell Secreted Nanoparticles (Exosomes)

SAN DIEGO, CA--(Marketwired - Aug 15, 2013) - Medistem, Inc. (PINKSHEETS: MEDS), announced today the publication of a patent application entitled "Therapeutic Immune Modulation by Stem Cell Secreted Exosomes."The patent application covers the use of stem cell derived nanoparticles, termed "exosomes", for the treatment of autoimmune conditions, including Type 1 Diabetes, multiple sclerosis, rheumatoid arthritis, and lupus.

"The data presented in the patent application provides additional insight into the mechanism by which our lead product, Endometrial Regenerative Cell (ERC-124), suppresses autoimmunity in animal models of multiple sclerosis and Type 1 diabetes," said Thomas E. Ichim, Ph.D., President and Chief Scientific Officer of Medistem and co-inventor of the patent application. "Our greater understanding of the mechanism of action of ERC-124 on the immune system, will contribute to our planned FDA submission of an Investigational New Drug (IND) to treat Type 1 Diabetes with our product."

The Company has previous published clinical proof of concept data in the in the field of autoimmunity.The Company reported four multiple sclerosis patients treated with ERC-124 in a peer-reviewed publication that can be found at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2649897/pdf/1479-5876-7-15.pdf).

"The data and intellectual property presented in the patent application supports the potential of using ERC-124 generated exosomes as an additional product candidate," said Alan J. Lewis, Ph.D., Chief Executive Officer of Medistem. "Given their size, ease of storage, and unique biodistribution, we anticipate ERC-124 derived exosomes may be used to treat burn wounds, radiation sickness, and extracorporeal treatment of organs for transplantation."

A copy of the patent application can be found at: http://medisteminc.com/exosome-patent-application/

About Medistem, Inc.

Medistem, Inc., is developing ERC-124, a universal stem cell product derived from the endometrium.ERC-124 possesses specialized abilities to stimulate new blood vessel formation and can differentiate into lung, liver, heart, brain, bone, cartilage, fat and pancreatic tissue. These unique properties have applications for treatment of critical limb ischemia (CLI), congestive heart failure (CHF), neurodegenerative diseases, liver failure, kidney failure, and diabetes. ERC-124 has been cleared by the FDA to begin a CLI clinical trial in the United States.In January 2012, the Company announced the initiation of its RECOVER-ERC (Non-Revascularizable IschEmic Cardiomyopathy treated with Retrograde COronary Sinus Venous DElivery of Cell TheRapy) a double blind, placebo controlled, clinical trial.This trial is being conducted at the Bakulev Scientific Center for Cardiovascular Surgery, Moscow, Russia.The trial is a 60 patient double blind placebo controlled study evaluating safety and efficacy of ERC-124 in end stage CHF patients.

Certain statements herein may be forward-looking and involve risks and uncertainties.Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Medistem, Inc.These can be identified by the use of forwardlooking words, such as "believes", "expects", "may", "intends", "anticipates", "plans", "estimates", or any other analogous or similar expressions intended to identify forwardlooking statements. These forwardlooking statements and estimates as to future performance, estimates, and other statements contained herein regarding matters that are not historical facts, are only predictions and actual events or results may differ materially. We cannot assure or guarantee that any future results described in this presentation will be achieved, and actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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Medistem Announces Patent Application on Stem Cell Secreted Nanoparticles (Exosomes)

Stem cell clients urged to report side effects

The Food and Drugs Administration (FDA) asked patients who underwent stem cell treatment and suffered adverse reactions to submit a report online.

Those who have availed such products or therapies and have experienced any untoward event or side effect or treatment failures as well as those currently availing such are highly encouraged to submit reports through the FDA website at http://www.fda.gov.ph under eReport and ADR (Adverse Drug Reaction) Report Section, FDA Advisory no. 2013-023 said. The government agency assured all reports will be treated with confidentiality.

This advisory is being issued as part of FDAs initiative to empower consumers in the surveillance and monitoring of drug safety, the advisory added.

Early this week, the Department of Health (DoH) announced the deadline for the application for accreditation of hospitals and health facilities offering stem cell-based treatments in the Philippines.

The Bureau of Health Facilities (BHFS) will lead the assessment of the health facilities.

Applications will be reviewed jointly by a bio-ethics committee and a hospital-based review board.

Some five big hospitals in Metro Manila have already submitted their application for accreditation. (Jenny F. Manongdo)

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Stem cell clients urged to report side effects

BrainStorm Cell Therapeutics Will Host a Conference Call to Update Shareholders on Recent Company Developments

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.

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BrainStorm Cell Therapeutics Will Host a Conference Call to Update Shareholders on Recent Company Developments

FDA Approves Stem Cell Clinical Trial For Multiple Sclerosis

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.

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FDA Approves Stem Cell Clinical Trial For Multiple Sclerosis

DOH gives health facilities engaged in stem cell therapy until Aug. 31 to register

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

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DOH gives health facilities engaged in stem cell therapy until Aug. 31 to register

DOH sets deadline for stem cell therapy accreditation

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.

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DOH sets deadline for stem cell therapy accreditation

Medical groups get support over bid for free stem cell

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)

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Medical groups get support over bid for free stem cell

Doctors hit stem cell promotion

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.

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Doctors hit stem cell promotion

Osiris Doubles on Study Showing Grafix Closes Wounds

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

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Osiris Doubles on Study Showing Grafix Closes Wounds