Stem Cell Clinic

Stem cell therapy to repair damaged knee cartilage

Jan. 24, 2013 Rush University Medical Center is conducting the nation's first clinical study of an innovative stem cell drug, Cartistem, to repair knee cartilage damaged by aging, trauma or degenerative diseases such as osteoarthritis.

Cartistem is manufactured from mesenchymal stem cells derived from allogeneic (donor) umbilical cord blood. Umbilical cord blood is a readily accessible source of high-quality stem cells, is associated with minimal health risks and carries relatively few ethical concerns.

The stem cells are mixed with hyaluronan, a natural polymer that plays a major role in wound healing and is a building block of joint cartilage. Cartistem is surgically administered into the area of cartilage damage following an arthroscopic surgery as an adjunct to microfracture, a commonly used technique used to repair cartilage damage.

The principal investigator on the study is Dr. Brian Cole, a professor in the department of orthopedics and anatomy and cell biology at Rush University Medical Center. Dr. Cole is the head of Rush's Cartilage Restoration Center and is also the head team physician for the Chicago Bulls. Cole and his co-researchers will assess the drug's safety as well as its ability to regenerate cartilage repair tissue and reduce pain in patients with localized cartilage loss in the knee.

Treating cartilage damage can be problematic because the tissue does not contain blood vessels or nerves and therefore has a limited ability to re-grow. Various treatments for cartilage degeneration, such as drug therapy, arthroscopy and joint replacement, yield mixed results and are unable to regenerate damaged tissue.

"Finding a biological solution for cartilage regeneration in orthopedics is one of the fastest growing areas of research and development in our specialty, said Cole. "Rush is spearheading this field of research with the ultimate goal of safely improving outcomes and sparing patients from having more complicated surgery at a relatively young age."

The two-year, phase I/IIa study will enroll a total of 12 participants aged 18 years and older, with a body mass index of less than 35. Initially, six individuals with lesions sized 2 to 5 centimeters will be recruited into the study; an additional six volunteers with lesions larger than 5 centimeters will be enrolled sequentially. Each participant will undergo eligibility screening followed by a 12-month observation period to determine the safety and efficacy of the drug with an additional long-term follow-up evaluation at 24 months.

"With a burgeoning aging, yet active population, our patients are looking for effective non-joint replacement solutions to treat their damaged knee cartilage," said Cole. "This research is significant in that it utilizes a commonly performed operation (microfracture) in an effort to improve upon variable outcomes."

"Notably, this is a treatment for patients with localized cartilage damage and not for patients who are diagnosed with diffuse or bone on bone arthritis who have otherwise been told they require a knee replacement." said Cole.

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Stem cell therapy to repair damaged knee cartilage

Keynote Message of Secretary Enrique T. Ona: Stem Cell Medicine 1st National Convention

Keynote Message of Secretary Enrique T. Ona

Philippine Society for Stem Cell Medicine

1st National Convention The Truth and Fallacies about Stem Cell Therapy

January 16, 2013, Pandanggo Hall, Manila Hotel

The establishment of the Philippine Society for Stem Cell Medicine composed of physicians with interest in stem cell therapy is opportune, with the increasing demand for the use of stem cells as therapy in oncology, end organ diseases and regenerative medicine, here now in the Philippines and worldwide. I congratulate the founding members, led by Dr. Jose Sabili, your Chairman and Dr Rey Melchor Santos, your President for recognizing the need to organize and professionalize the practice of stem cell therapy in this country.

This two-day national convention, with the theme The Truth and Fallacies about Stem Cell Therapy is very timely as we in the Department of Health and the medical profession try to clear the air of misinformation and half-truths regarding this popular mode of treatment. We owe it to our patients and the general public to ensure that proper information and guidance regarding this novel medical approach is available. To protect themselves and their loved ones, the public must know the most current and accurate information about stem cells and its various applications, including some of which are purely experimental. We must ensure that only safe and ethical uses of stem cells are being used in the Philippines.

Today, we see the proliferation of centers offering stem cell treatments for medical and aesthetic purposes. Some stem cell programs here have expert personnel and clinical facilities and advanced laboratory equipment and technologies, reputed to be more advanced than other institutions abroad. We are concerned, however, that other facilities might not have the minimum capabilities especially trained personnel staff and equipment needed to perform stem cell therapies safely and effectively.

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Keynote Message of Secretary Enrique T. Ona: Stem Cell Medicine 1st National Convention

BrainStorm’s CEO Issues Annual Letter to Shareholders

NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--

BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that its CEO, Dr. Adrian Harel, has issued an Annual Letter to Shareholders summarizing the companys extremely significant developments of 2012:

Dear BrainStorm Shareholders,

2012 has been a pivotal year for BrainStorm, as the company has achieved the most significant milestones since its inception. Weve made dramatic progress in our clinical trials, establishing the safety of NurOwn cells in a first group of ALS patients and demonstrating promising indications of clinical improvement in some patients. As a result weve been fast-tracked to a Phase IIa preliminary efficacy trial after only one year of testing. Weve also made key advances in product development, and secured the largest amount of financing in any single year of operations. I am proud to share with you the major highlights of the past twelve months:

I. Clinical Trials Progress

In early June, we performed the 12th ALS patient transplantation in our Phase I/II clinical trial with NurOwn at Hadassah Medical Center in Jerusalem. In July, we submitted a positive interim safety report to the Israeli Ministry of Health (MOH) on the first 12 ALS patients in the study, demonstrating that treatment was well-tolerated and that there were promising indications of clinical improvement in some of the patients.

Just as we welcomed in 2013, the MOH approved acceleration to a Phase IIa dose-escalating trial to further evaluate the safety and preliminary efficacy of NurOwn treatment. In the Phase IIa trial, which we are launching this month, a second group of 12 patients will receive combined intramuscular and intrathecal administration of NurOwn cells in three cohorts, with increasing doses. The study participants, who have already been recruited, will be monitored for three to six months after transplantation.

In addition, preparations are well underway for a Phase II clinical trial in the USA, scheduled for 2013, pending FDA approval.

II. Advances in Product Development

In December 2012, we signed a strategic agreement with Octane Biotech of Kingston, Ontario, to jointly develop a proprietary bioreactor for production scale-up of NurOwn. The customized bioreactor will enable us to significantly increase our production capabilities by using a single clean room for multiple patients, reducing costs and time. We are very excited to be working with Octane, given their expertise in developing automated production processes for mesenchymal cell therapy technologies. The project is currently being launched.

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BrainStorm’s CEO Issues Annual Letter to Shareholders

Vitro Biopharma Launches New Stem Cell Products to Accelerate Bone Growth

GOLDEN, Colo., Jan. 22, 2013 (GLOBE NEWSWIRE) -- Vitro Diagnostics, Inc. (VODG), dba Vitro Biopharma, announced the launch of a series of products with application to accelerated bone growth, fracture healing and development of new osteoporosis drugs. The new products are osteoblasts derived from human adult stem cells known as mesenchymal stem cells (MSCs). These cells lead to bone growth and function to maintain bone density and in the recovery from bone fractures. Osteoporosis, a disease characterized by reduction in bone density is thought to result from decreased osteoblast production by MSCs; bone growth necessary for repair of bone fractures also depends on osteoblasts. The new products include native and labeled MSC-derived human osteoblasts in various formats including fluorescent and magnetic cells for use in different imaging methods. For example, magnetic osteoblast cells labeled with super paramagnetic iron oxide (SPIO) may be used for in-vivo imaging of osteoblasts using magnetic resonance imaging (MRI) a common clinical imaging procedure. The availability of native and multiply-labeled osteoblasts provides numerous options to conduct in-vitro high throughput screening cell assays and to coordinate these studies with in-vivo studies.

Dr. Jim Musick, Vitro Biopharma's President & CEO, said, "We are pleased to announce commercial availability of our MSC-derived human osteoblasts, the latest in our line of MSC-derived differentiated cells intended for applications in drug discovery and development as well as regenerative medicine. Diseases and injury to the skeletal system pose significant health risk and impairment of function. The incidence of osteoporosis continues to rise with the aging population. Bone fractures are common injuries requiring long healing times and significant loss of production. Improved treatment of osteoporosis and accelerated recovery from bone fractures both provide significant health benefits. We are pleased to offer our new products to assist in the achievement of these objectives. We have additional related products in our pipeline and plan to engage in animal studies in the near future to determine the application of our new products to accelerated healing and regenerative medicine."

About Vitro Biopharma

Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB:VODG; http://www.vitrobiopharma.com), owns US patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. In 2011, Vitro Biopharma out-licensed its intellectual property related to treatment of infertility to Dr. James Posillico, a renowned expert in Assisted Reproductive Technologies. Vitro Biopharma also owns a pending US patent for generation of pluripotent stem cells and an additional pending patent for methods of mesenchymal stem cell (MSC) generation and related materials. Vitro Biopharma's mission is "Harnessing the Power of Cells(TM)" for the advancement of regenerative medicine to its full potential. Vitro Biopharma operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro Biopharma manufactures and sells "Tools for Stem Cell and Drug Development(TM)", including human mesenchymal stem cells and derivatives, the MSC-Gro(TM) Brand of optimized media for MSC self-renewal and lineage-specific differentiation. In addition to our FSH patent licensee, Vitro Biopharma maintains several strategic partnerships including an alliance with Neuromics, Inc. (www.neuromics.com). Neuromics, Inc. is a primary distributor of Vitro Biopharma products and a well established manufacturer and distributor of a large variety of life science research products especially focused on cell-based assay systems We jointly manufacture stem cell assay systems with HemoGenix(R), Inc. (http://www.hemogenix.com/), known as the LUMENESC(TM) quantitative assay for determination of MSC quality, potency and response to toxic agents. Stemgenesis, Inc. (http://www.stemgenesisinc.com ) is a Chinese-based firm with operations in Qingdao, Shandong Province, China and with US operations in Sacramento, CA. Vitro Biopharma has an agreement with Stemgenesis, Inc. for distribution of its stem cell products into select Chinese provinces. Also, Vitro Biopharma's CEO is a consultant on an NSF grant at the City College of New York to advise Dr. Lane Gilcrest, Professor of Materials Science and Engineering, and his colleagues regarding the development of novel extracellular materials for use in self-renewal and differentiation of mesenchymal stem cells.

Safe Harbor Statement

Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward looking statements, whether as a result of new information, future events or otherwise.

CONTACT:

Dr. James Musick

Chief Executive Officer

Vitro Biopharma

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Vitro Biopharma Launches New Stem Cell Products to Accelerate Bone Growth

Vistagen Therapeutics Successfully Completes Final Phase 1 Safety Study of AV-101

SOUTH SAN FRANCISCO, CA--(Marketwire - Jan 23, 2013) - VistaGen Therapeutics, Inc. ( OTCQB : VSTA ), a biotechnology company applying stem cell technology for drug rescue, predictive toxicology and drug metabolism screening, today announced the successful completion of its final Phase 1 safety study of AV-101, a novel orally available prodrug candidate being developed for treatment of multiple conditions involving chronic neuropathic pain.The study results indicate that AV-101 is safe and well tolerated, with favorable bioavailability and pharmacokinetics.

"This important confirmation of AV-101's safety is the final step in our Phase 1 program for AV-101," said Shawn K. Singh, JD, VistaGen's Chief Executive Officer. "With $8.8 million of funding from the National Institutes of Health (NIH) and outstanding strategic development and regulatory support from Cato Research Ltd., we have successfully completed the required studies enabling Phase 2 clinical development of AV-101 for multiple large market neurological diseases and conditions.In addition, recent data from the NIH suggest that the same neural pathway modified by AV-101 may be useful for treating depression.Launching a broad strategic collaboration to advance development and commercialization of AV-101 is among our key goals in 2013."

About the Final AV-101 Phase 1 Safety Study

VistaGen's final AV-101 Phase 1 safety study was a randomized, double-blind, placebo-controlled, dose-escalation clinical trial conducted at the University of California, San Diego (UCSD).The study involved three cohorts of healthy volunteers, each receiving multiple daily treatments of one of three dose levels of orally administered AV-101 over a 14-day period. The primary objectives of the study were to evaluate the safety, tolerability and pharmacokinetics (PK) of three different daily doses of AV-101 compared to placebo controls.A total of 46 healthy volunteers completed the study.The oral administration of AV-101 was safe and well tolerated by all subjects at all three dose levels tested.In addition, the PK of AV-101 was fully characterized across the range of three dose levels in the study.The data indicate that AV-101 had good bioavailability and a favorable PK profile.

"The primary safety and tolerability endpoints of the Phase 1 program were met.This is a very safe compound with no observed side effects," commented Mark S. Wallace, MD, Chair of the Division of Pain Medicine, Department of Anesthesiology at UCSD and the principal investigator of the study."AV-101 is an exciting prodrug compound that acts through a promising mechanism to treat pain.I am excited to move this compound into Phase 2 studies for the treatment of pain."

About AV-101

Aimed at multi-billion dollar neurological disease and disorders and depression markets, AV-101, also known as "L-4-chlorokynurenine" (4-Cl-KYN), is a novel, orally available prodrug that is converted in the brain into an active metabolite, 7-chlorokynurenic acid (7-Cl-KYNA), which regulates an important neurotransmitter in the brain called the N-methyl-D-aspartate (or NMDA) receptor.A synthetic analogue of kynurenic acid, a naturally occurring neural regulatory compound, 7-Cl-KYNA is one of the most potent and selective blockers of the regulatory GlyB-site of the NMDA receptor.

VistaGen's AV-101 IND application covers clinical development for neuropathic pain. In addition to neuropathic pain, VistaGen expects the results of its Phase 1 clinical program to be useful for supporting the development of AV-101 for other neurological disorders including depression and epilepsy.

About VistaGen Therapeutics

VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue, predictive toxicology and drug metabolism screening. VistaGen's drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, with modern medicinal chemistry to generate novel, safer chemical variants (Drug Rescue Variants) of once-promising small molecule drug candidates. These are drug candidates discontinued by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories, after substantial investment in discovery and development, due to heart or liver toxicity or metabolism issues. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans, bringing human biology to the front end of the drug development process.

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Vistagen Therapeutics Successfully Completes Final Phase 1 Safety Study of AV-101

Tuning stem cell fate: Researchers uncover epigenetic mechanisms of embryonic stem cell pluripotency and differentiation

Jan. 22, 2013 The research group of Luciano Di Croce, from the Center for Genomic Regulation (CRG) in Barcelona (Spain), has discovered that RYBP and CBX7, two proteins essential for gene regulation, are at the heart of the most critical decision faced by embryonic stem cells: what type of cells to become. These findings, published in the last issue of Cell Reports, shed light on the molecular mechanisms involved in stem cell biology and might have important therapeutic implications.

Stem cells are the precursors of our tissue and organs. Using them could be highly promising for regenerative medicine, yet little is known about the mechanisms that regulated the potential of stem cells to give rise to the different cell types within organisms.

The Polycomb repressive complex 1 (PRC1) is an epigenetic regulator essential for stem cell function and cancer progression. It has only recently become clear that PRC1 comes in different flavors, depending on which specific proteins are incorporated into it (such as either CBX7 or RYBP). However, whether or not these PRC1 subtypes carry out different biological functions was unclear. This work, headed by Lluis Morey in the Di Croce group, has taken an important step in clarifying this question.

Using the most advanced sequencing technology, Di Croce and his coworkers analyzed 2.64 billion DNA nucleotides from mouse embryonic stem cells to determine which regions are controlled by PRC1-RYBP as compared to PRC1-CBX7. Both complexes shared some biological functions. Surprisingly, however, the two complex subtypes also performed distinct functions. We were able to show that these two complex subtypes can have different roles, with one involved more in metabolism and the other more in development, commented Morey.

Understanding the extent to which the different PCR1 subtypes carry out the critical decisions that determine cell fate presents the next large goal. We are lucky to be able to address these questions within a network of experts in our European FP7 4DCellFate project, since we believe that the answers will be important for understanding how to implement stem cells into therapeutic applications, stated Di Croce.

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Tuning stem cell fate: Researchers uncover epigenetic mechanisms of embryonic stem cell pluripotency and differentiation

Stem Cell Joint Repair Treatment Osteoarthritis Cartilage in Bangkok, Thailand

Food and Healthcare Press Releases Monday January 21, 2013

Bangkok--21 Jan--Urban Beauty Thailand

Osteoarthritis is the most common form of arthritis. It causes pain, swelling and reduced motion in your joints. It can occur in any joint, but usually affects your hands, knee, hips or spine. Thailand Osteoarthritis breaks down the cartilage in your joints. Cartilage is the slippery tissue that covers the ends of bones in a joint. Healthy cartilage absorbs the shock of movement. When you lose cartilage, your bones rub together. Over time, this rubbing can permanently damage the joint. Factors that may cause osteoarthritis include:

Being overweight

Getting older

Injuring a joint

Thailand Osteoarthritis, or OA, is often related to aging, although sometimes the cause is not known. Before the age of 55 it occurs equally in women and men. After that age it is more common in women. By the age of 70 the majority of people will have at least minor Osteoarthritis.

Stem cell treatment in Thailand is one of the best options to get rid of osteoarthritis. Like many other procedures osteoarthritis treatment in Thailand uses autologous adult stem cells. These are harnessed from the patients fat cells so there is very little chance of patients body rejecting them.

Adipose (fat) tissue extraction tends to be more worthwhile than other methods such as bone marrow extraction. This is because it produces up to ten times more stem cells. Adipose derived stem cells (ASCs) have been shown to be just as effective as other stem cells as they display proliferative efficiency and multipotency in tissue regeneration.

Stem cell treatment in Bangkok uses new technology known as Adistem Cell Technology. Photoactivation Technology has been used for activating adipose derived stem cells (ASCs) for therapeutic and regenerative application since 2008. This technology uses low intensity of light at specific frequencies to increase various anti-inflammatory and healing agents from ASCs. Harvesting ASCs is done through a simple, minimally invasive liposuction under local anesthesia. The process is relatively easy and painless and poses minimal risk to the patient. It is a single procedure in a sterile setting. After harvesting, the stem cells are separated from the fats using standard technique.

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Stem Cell Joint Repair Treatment Osteoarthritis Cartilage in Bangkok, Thailand