Stem Cell Clinic

Cease and desist order against stem cell ads sought

The Philippine College of Physicians (PCP) asked the Food and Drug Administration (FDA) to issue a cease and desist order with sanctions against all forms of advertisement on stem cell therapy until the government has come up with conclusive studies on its efficacy on diseases.

In a media briefing, the doctors said FDAs efforts in governing the use and practice of stem cell treatment in the country is not enough to stop those who offer them despite the absence of clear and conclusive clinical trials on it.

The recent guidelines released by the FDA fell short and will not stop the proliferation of storm cell therapy for ailments that were not subjected to scientific study or clinical trials. We will not back down from our earlier call and we will not stop until stem cell therapy undergoes scientific studies to prove its safety, quality and efficacy on the ailments it has been propagated. We will not allow its promotion and use to helpless and unknowing patients and their desperate families, Dr. Prescilla Caguioa, PCP president said.

Tony Leachon, PCP Vice President also urged the FDA to stop unaccredited health and commercial facilities to offer the treatment.

Recently, the FDA released an order asking health facilities offering stem cell therapy to file their application for accreditation until August 31. This follows a similar order in June where FDA issued circular no. 2013-0017 that required all human cells, tissues and cellular and tissue-based products to be registered as well.

As of August 31, FDA said only 47 medical institutions have applied for accreditation.

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Cease and desist order against stem cell ads sought

Complete 2012-13 Induced Pluripotent Stem Cell Industry Report (Updated)

Dublin, Sept. 24, 2013 (GLOBE NEWSWIRE) -- Research and Markets (http://www.researchandmarkets.com/research/qzbnvh/complete_201213) has announced the addition of the "Complete 2012-13 Induced Pluripotent Stem Cell Industry Report" report to their offering.

Stem cell research and experimentation has been in process for well over five decades, as stem cells have the unique ability to divide and replicate repeatedly. In addition, their unspecialized nature allows them to differentiate into a wide variety of specialized cell types. The possibilities arising from these characteristics has caused great commercial interest, with potential applications ranging from the use of stem cells in reversal or treatment of disease, to targeted cell therapy, tissue regeneration, pharmacological testing on cell-specific tissues, and more. Diseases such as Huntington's Chorea, Parkinson's Disease, and spinal cord injuries are examples of clinical applications in which stem cells could offer benefits in halting or even reversing damage.

Traditionally, scientists have worked with both embryonic and adult stem cells as research tools. While the appeal of embryonic cells has been their ability to differentiate into any type of cell, there has been significant ethical, moral and spiritual controversy surrounding their use for research purposes. Although some adult stem cells do have differentiation capacity, it is often limited nature, which creates narrow options for use. Thus, induced pluripotent stem cells represent a promising combination of adult and embryonic stem cell characteristics.

A distinctive feature of this report is an end-user survey of 293 researchers (181 U.S. / 112 International) that identify as having induced pluripotent stem cells as their core research focus. These survey findings reveal iPSC researcher needs, technical preferences, key factors influencing buying decisions, and more. They can be used to make effective product development decisions, create targeted marketing messages, and produce higher prospect-to-client conversion rates.

Remember, to benefit from this lucrative product market, you need to anticipate and serve the needs of your clients, or your competitors will.

Key Findings Include:

In summary, this is a must-read industry report for research supply companies to optimally position themselves to sell iPSC products. To profit from this lucrative and rapidly expanding market, you need to understand your key strengths relative to the competition, intelligently position your products to fill gaps in the market place, and take advantage crucial iPSC trends. Claim this report now to profit from this expanding market - or your competition will.

Table of Contents

I. ABSTRACT

II. BACKGROUND

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Complete 2012-13 Induced Pluripotent Stem Cell Industry Report (Updated)

Leading Stem Cell Clinic in California, TeleHealth, Now Offering 3 Different Stem Cell Therapy Treatments

Orange County, CA (PRWEB) September 23, 2013

The leading regenerative medicine clinic on the West Coast, TeleHealth, is now offering three different types of stem cell therapy injections. The California stem cell treatments are predominantly covered by insurance, and performed by Board Certified stem cell doctors. For more information and scheduling, call (888) 828-4575.

The stem cell treatments are excellent for joint arthritis, tendonitis, ligament injuries, and spinal arthritis along with degenerative disc disease. Initial research with small studies has shown regenerative medicine treatments are working well for degenerative conditions, such as the recent study out of the Hospital for Special Surgery.

One of the treatments offered is bone marrow derived stem cell injections. These are outpatient procedures that involve harvesting the patient's own bone marrow, processing it, and injecting into the area of concern at the same setting. These bone marrow stem cell injections have very low risk and the potential for helping regenerate damaged cartilage and soft tissue from such conditions as achilles tendonitis, rotator cuff tendonitis and tennis elbow.

The second procedure offered is platelet rich plasma therapy. This procedure involves a simple blood draw from the patient, and the blood is centrifuged for approximately 15 minutes. This separates the blood into concentrated platelets and growth factors, which are then injected into the problem area. This material then calls in the body's stem cells to facilitate further repair. At times PRP is used in conjunction with bone marrow derived stem cell injections.

The third procedure utilized is fat derived stem cell injections, which has the same indications as bone marrow derived.

TeleHealth sees patients from a broad area of the west coast and offers Board Certified doctors providing treatment. To seek treatment with the premier stem cell therapy clinic, call (888) 828-4575.

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Leading Stem Cell Clinic in California, TeleHealth, Now Offering 3 Different Stem Cell Therapy Treatments

Bioheart Announces Agreement With Invitrx to License Adipose Derived Stem Cells

SUNRISE, FL--(Marketwired - Sep 23, 2013) - Bioheart, Inc. (OTCQB: BHRT), a biotech company focused on the discovery, development and commercialization of autologous cell therapies for the treatment of chronic and acute heart damage as well as severe peripheral vascular disease announces that it has entered into an agreement with Invitrx Therapeutics to license their adipose derived stem cell products.The license agreement term sheet for adipose derived cells is for use in all indications in both human and animal medicine.

Invitrx Therapeutics is a biotechnology company specializing in the culture and engineering of adult stem cells, innovative products and therapies that are used in aesthetics, wound closure, and healing, as well as, plastic and reconstructive surgery.The team at Invitrx has been working with adipose derived stem cells for over 10 years and this experience can contribute to the development and commercialization of AdipoCell (Bioheart's adipose stem cell product).

Bioheart has recently completed enrollment in the Phase I Angel Trial using adipose derived stem cells.Preliminary 3 month follow up results will be released later this quarter.

"Combining the experience and expertise of the team at Invitrx with the currently available Bioheart products will strengthen our program.We are looking forward to expanding the Angel trial and incorporating some of the newly licensed techniques," said Mike Tomas, CEO of Bioheart, Inc.

Habib Torfi, Chairman and CEO of Invitrx, said, "Invitrx Therapeutics is looking forward to join forces with Bioheart Inc. to help advance and expand the product lines and the existing clinical trials in the stem cell field."

About Bioheart, Inc

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues.Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com, or visit us on Facebook: Bioheart and Twitter @BioheartInc.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

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Bioheart Announces Agreement With Invitrx to License Adipose Derived Stem Cells

Poway man in groundbreaking stem cell Parkinsion’s study

By Emily Sorensen

A Poway man is part of a groundbreaking study that could lead to new advances in the treatment of Parkinsons disease.

Michael Radunsky, a Poway resident, is one of eight Parkinsons patients participating in a special study at Scripps Clinic Movement Disorders Center, where cutting-edge stem cell research may lead to a viable long-term treatment for those afflicted with Parkinsons disease.

Michael Radunsky

I am proud to be a participant in this seminal research project, said Radunsky, who has been involved with the study for about a year and a half. The study involves harvesting the skin cells, or fibroblasts, from a Parkinsons patient, reprogramming these cells into induced pluripotent stem cells (iPSC), further reprogramming the iPSC into dopamine-producing neurons, and finally, implanting these neurons into the patients substantia nigra, a small element deep in the brain which contains neurons that normally produce dopamine. Dopamine is a neurotransmitter that is used to regulate motor activity. In Parkinsons patients, these neurons begin to die and do not produce enough dopamine, according to Radunsky.

The goal of the study is to have the newly implanted neurons replace the dying ones to regulate the motor functions of Parkinsons patients. Radunsky said that so far, his cells are on step two of the progress, waiting to be further reprogrammed into neurons.

A key factor in this study is that the stem cells are derived from a patients own skin cells and not from embryos or other willing or unwilling donors. The ethical issue of embryonic stem cell research and treatments is entirely eliminated by obtaining the stem cells directly from the patient without harm or the termination of a pregnancy, said Radunsky.

Radunsky, who lives in Poway with his wife, Stephanie, and their two young children, was diagnosed with Parkinsons about two years ago, in August of 2011. He works in the photonics industry for a company that builds lasers used for ultra-cold atom physics.

It was his neurologist, Dr. Melissa Houser, who got him involved in the study. Houser is the leading clinical physician in the study, and recommended that he be involved.

Radunsky said that in six to eight months, implantation surgeries will begin, and will be followed by careful observation to see the effects of implanting the new neurons. I will make myself available to the project for as long as is necessary, said Radunsky. This will undoubtedly mean years of follow up.

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Poway man in groundbreaking stem cell Parkinsion’s study

Bioheart Boosts Team With Regulatory, Finance and Administrative Expertise

SUNRISE, FL--(Marketwired - Sep 20, 2013) - Bioheart (OTCQB: BHRT), a leader in developing stem cell therapies to treat cardiovascular diseases, has expanded its team by adding three key strategic positions with regulatory, finance and administrative expertise.

"This experienced and talented team will assist Bioheart in its transformation to a late stage clinical biotechnology company," said Mike Tomas, CEO of Bioheart.

Joining as Senior Compliance Officer of Bioheart, Dr. Colleen Robb ensures third-party objectivity in all internal processes, and works with management on external negotiations and the development of Bioheart's FCPA protocols as the company expands international efforts. With more than 14 years of experience in the non-profit sector, Dr. Robb is recognized internationally as a prominent researcher in the area of social entrepreneurship and strategy, specifically examining how social ventures can maintain advantage in the marketplace. Prior to joining Bioheart, she was an Assistant Professor of undergraduate and graduate programs at Keller Graduate School of Management at DeVry University. Dr. Robb received her doctoral degree from bo Akademi University in Turku, Finland and her master's degree in business administration from Florida International University.

Finance and Operations Manager Gisela Freeman is a tenured legal and finance operations executive with more than 20 years experience who, prior to joining Bioheart, served as a Service Representative for the Social Security Administration offices of the federal government in Miami, providing assistance to beneficiaries and representative payees.

Susana Mestre, Administrative Manager, has more than 10 years experience successfully leading internal operations for technology businesses. Prior to joining Bioheart, she served as President for Euro Broadcast Corporation in Miami, where she was responsible for handling the company's accounting and finances, as well as customer service. She received her Associate of Arts degree from Miami Dade College and a graduate degree in Foreign Language from the Universita Per Stranieri in Perugia, Italy.

About Bioheart

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues.Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com, or visit us on Facebook: Bioheart and Twitter @BioheartInc.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

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Bioheart Boosts Team With Regulatory, Finance and Administrative Expertise

OncoMed Pharmaceuticals Initiates Phase 1b/2 Clinical Trial of Demcizumab (Anti-DLL4) in Combination with Paclitaxel …

REDWOOD CITY, Calif., Sept. 19, 2013 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that it has started a Phase 1b/2 clinical trial of its anti-cancer stem cell product candidate, demcizumab (OMP-21M18) in ovarian cancer. The trial will enroll patients at the MD Anderson Cancer Center in Houston, TX, and is being funded in part under an ovarian cancer National Cancer Institute SPORE Grant Program.

In this Phase 1b/2 trial, demcizumab is being tested in combination with paclitaxel in patients with platinum-resistant ovarian cancer, fallopian tube cancer or primary peritoneal cancer. Following a Phase 1b safety run-in, a Phase 2 clinical trial will proceed in these patients. The primary endpoints of the Phase 2 part of the trial will be to determine the progression-free survival and response rate of the novel demcizumab with paclitaxel combination. Key secondary and exploratory endpoints include overall survival, biomarker endpoints and safety.

Dr. Robert Coleman, Professor & Vice Chair, Clinical Research, Department of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center in Houston, TX, and the Principal Investigator who treated the first patient on the study noted, "Women with platinum-resistant ovarian, fallopian tube and primary peritoneal cancers are in need of new treatment options. We believe that an investigational therapy such as demcizumab, with its novel anti-cancer stem cell mechanism of action, could yield important results for these patients."

"The trial includes a number of translational science and biomarker evaluations that will help to elucidate the mechanisms by which demcizumab works for the treatment of ovarian cancer patients and aims to identify predictors of response to therapy," said Dr. Anil Sood, Professor & Vice Chair, Translational Research in the Department, who will be working on the trial.

The trial is OncoMed's fourth Phase 1b trial of demcizumab, and the second portion of this protocol would represent the first Phase 2 trial of demcizumab. Previous Phase 1b trials combining demcizumab with chemotherapy regimens have been initiated in patients with first-line pancreatic cancer (with gemcitabine and Abraxane(TM)), first- or second-line colorectal cancer (with FOLFIRI chemotherapy) and first-line non-small cell lung cancer (with carboplatin and pemetrexed chemotherapy). The Phase 1b trials in pancreatic cancer and non-small cell lung cancer are currently enrolling patients.

"We believe ovarian cancer is another important cancer indication for the demcizumab clinical program and an area of high unmet medical need," said Dr. Jakob Dupont, Chief Medical Officer of OncoMed. "We have observed strong preclinical efficacy of demcizumab and paclitaxel in patient-derived ovarian cancer xenograft models, as well as early evidence of activity of demcizumab in ovarian cancer in the Phase 1a single-agent study of demcizumab."

Paul Hastings, Chairman and Chief Executive Officer of OncoMed, emphasized, "The ovarian cancer trial provides the earliest opportunity to advance a demcizumab program to Phase 2. As such it will represent a significant advance for this unpartnered anti-cancer stem cell asset."

About Demcizumab

Demcizumab (OMP-21M18) is a humanized monoclonal antibody that inhibits Delta-Like Ligand 4 (DLL4) in the Notch signaling pathway. Two Phase 1b combination trials of demcizumab are ongoing. The first trial is in combination with standard-of care gemcitabine and Abraxane(TM) in first-line advanced pancreatic cancer patients, and the second trial is in combination with standard of care carboplatin and pemetrexed (Alimta(TM)) in first-line advanced non-small cell lung cancer (NSCLC) patients. Data from the demcizumab NSCLC Phase 1b trial were presented at the EORTC-AACR-NCI Molecular Targets and Cancer Therapeutics Meeting in Dublin, Ireland in November 2012. In addition, a Phase 1b/2 trial of demcizumab and paclitaxel in patients with platinum-resistant ovarian cancer has been initiated. OncoMed has worldwide rights to this program.

About Cancer Stem Cells

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OncoMed Pharmaceuticals Initiates Phase 1b/2 Clinical Trial of Demcizumab (Anti-DLL4) in Combination with Paclitaxel ...