Stem Cell Clinic

An end to the stem cell ‘hammer’ and ‘nail’

Medical Files By Rafael Castillo M.D. Philippine Daily Inquirer

(Conclusion)

A saying goesif youre a hammer, you see everything as a nail.

This may symbolize whats happening to our practice of stem cell medicine in our country. Because of the media hype focusing on testimonials of celebrities on supposed spectacular healing or rejuvenation, stem cell practitioners coming from various medical practices have suddenly become overenthusiastic of the things stem cells could do for their patients. In every Tom, Dick and Harry, one or another indication for stem cell therapy can be seen at the end of a 5-minute consultation. It has been estimated that nine out of 10 Filipino patients administered stem cell treatment receive it for unproven and still experimental indications.

A neurosurgeon colleague asked the young doctor-son of a patient (who appeared to be fresh out of medical school) what his line of practice was, and he confidently replied that he administers stem cell medicine. When told that it seems to be a pretty complicated specialty, he answered without batting an eyelash that its not.

All of a sudden, a few hundred physicians from several specialtiesinternists, oncologists, surgeons, neurologists, dermatologists, OB-gynecologists, family medicine and practically all othershave seemingly converged to make stem cell medicine their specialty or subspecialty. I know that the doctors mean well. Most of them (including those who sent me angry SMS or e-mail messages after reading the first part of this column last week) sincerely believe they could offer something short of miraculous healing for their patients.

Not hammers at all

I dont doubt their well-meaning intentions but they just have to stop acting like a hammer, finding everything like a nailjudging practically everyone who comes to them as a potential stem cell treatment candidate. In fact, many colleagues who practice stem cell medicine should realize theyre not hammers at all. They should be honest enough to admit that they do not possess the competence to administer such a complicated therapy to their patients.

Being interested in stem cell medicine and considering oneself as an eager student wanting to learn more about this promising experimental form of treatment is good. But thinking that one can be good enough to administer it to patients after observing how others do it several times is definitely betraying ones sworn duty as a physicianto make patients well and not to administer anything that can potentially cause him or her more harm than good.

When I was a medical student at the University of Santo Tomas, every morning I would be reminded by the sculpted Latin phrase on the faade of the Medicine Building which said, Primum non nocere (First, do no harm). This is one of the principal precepts of medical ethics that all medical practitioners pledge to adhere to.

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An end to the stem cell ‘hammer’ and ‘nail’

Stem Cell Therapeutics Announces Participation at the 15th Annual Rodman & Renshaw Global Investment Conference in New …

TORONTO, ONTARIO--(Marketwired - Sep 6, 2013) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS)(SCTPF), a biopharmaceutical company developing cancer stem cell-related therapeutics, today announced it will be featured as a presenting company at the 15th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC. The conference is being held September 8-10, 2013, at the Millennium Broadway Hotel in New York City. Dr. Niclas Stiernholm, the CEO of Stem Cell Therapeutics, will provide an overview of the Company's business during the live presentation and will be available to participate in one-on-one meetings with investors who are registered to attend the conference.

About Stem Cell Therapeutics:

Stem Cell Therapeutics Corp. (SCT) is a biopharmaceutical company dedicated to advancing cancer stem cell discoveries into novel and innovative cancer therapies. Building on over half a century of leading and groundbreaking Canadian stem cell research, the company is supported by established links to a group of Toronto academic research institutes and cancer treatment centers, representing one of the world's most acclaimed cancer research hubs. The Company has two premier preclinical programs, SIRPaFc and a CD200 monoclonal antibody (mAb), which target two key immunoregulatory pathways that tumor cells exploit to evade the host immune system. SIRPaFc is an antibody-like fusion protein that blocks the activity of CD47, a molecule that is upregulated on cancer stem cells in AML and several other tumors. The CD200 mAb is a fully human monoclonal antibody that blocks the activity of CD200, an immunosuppressive molecule that is overexpressed by many hematopoietic and solid tumors. SCT's clinical stage programs include the recently in-licensed program focused on the structure of tigecycline, which is currently being evaluated in a multi-centre Phase I study in patients with acute myeloid leukemia (AML), as well as TTI-1612, a non-cancer stem cell asset that recently completed a 28-patient Phase I trial in interstitial cystitis ("IC") patients. For more information, visit: http://www.stemcellthera.com.

Caution Regarding Forward-Looking Information:

This press release may contain forward-looking statements, which reflect SCT's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include changing market conditions; the successful and timely completion of pre-clinical and clinical studies; the establishment of corporate alliances; the impact of competitive products and pricing; new product development risks; uncertainties related to the regulatory approval process or the ability to obtain drug product in sufficient quantity or at standards acceptable to health regulatory authorities to complete clinical trials or to meet commercial demand; and other risks detailed from time to time in SCT's ongoing quarterly and annual reporting. Except as required by applicable securities laws, SCT undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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Stem Cell Therapeutics Announces Participation at the 15th Annual Rodman & Renshaw Global Investment Conference in New ...

Stem-cell therapy 'can be lethal'

People considering stem-cell treatment have been advised to think again, with six groups of medical specialists issuing a strong warning yesterday that unlicensed stem-cell treatments on offer could kill a patient.

The medical societies that issued the statement include the Royal College of Physicians, the Dermatological Society, Heart Association of Thailand under the Royal Patronage of His Majesty the King, the Thai Society of Haematology, the Nephrology Society and the Neurology Society.

The statement said the Medical Council of Thailand had only approved the use of stem-cell treatment on blood diseases - namely leukaemia, malignant lymphoma, aplastic anaemia, multiple myeloma and thalassemia.

Clinical research on the use of stem-cell treatment is ongoing, but there is no scientific evidence that stem-cell therapy can effectively increasing a person's longevity, or delay organ degeneration or improve a patient's quality of life, Prof Kriang Tungsanga, president of the Royal College of Physicians, said.

The move by the medical societies was prompted by widespread ads about stem-cell-based "miracle pills" that claim to ease the symptoms of chronic symptoms such as diabetes and heart disease.

The unlicensed use of stem-cell therapy to treat heart disease, diabetes or for aesthetic purposes has become popular among celebrities and rich people who can afford the treatment, which can cost anything from Bt100,000 to Bt1 million.

Some patients even fly to private clinics in Germany to receive stem-cell injections extracted from unborn sheep that they believe will improve their health and make them look younger.

However, Kriang reiterated that stem-cell therapy is not recommended or included in the standard clinical practice guidelines of any disease other than some blood conditions.

Wrong usage 'can hurt'

Moreover, inappropriate use of stem-cell therapy may be harmful to patients as they could develop an allergy, clotting in blood vessels, contamination of the blood stream, foreign protein materials, chemicals microbial organisms and other non-pure types of cells and cancer transforming cells.

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Stem-cell therapy 'can be lethal'

Time to shine

A Clarenville couple is hoping their ordeal with leukemia is over after receiving a stem cell transplant from an anonymous donor from Halifax.

In 2008, Janice Davidson was diagnosed with Acute Myeloid Leukemia and immediately underwent an aggressive series of treatments.

The first time around her cancer was put into remission quite quickly.

She was cancer for free for almost two years when it came back in 2011.

The next step in the treatment process was to do a stem cell transplant using Janice's own stem cells instead of a donor's.

In layman's terms, it is a process in which stem cells are taken out and then put back in the patient after they are put in remission.

Janice's husband, Ian Davidson, says she had a difficult time with the process but came through the ordeal and was cancer free for another year and a half.

Then the cancer came back again.

"This time, our only option was the stem cells of a donor, because her system is clearly broken. Janice didn't have a match in her own family, only 25 per cent of people find matches within their own family so it's not as high as you would think," says Davidson.

It's much more desirable to have a match in the family because there are more genetic markers that are similar and it reduces the risk of a phenomenon called graft-versus-host disease, a complication associated with stem cell or bone marrow transplant. When the body recognizes that it's not its original cells, the body can attack itself. It can be very mild or it can be life threatening.

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Time to shine

Ottawa research team leading study that allows heart to heal itself

OTTAWA A team of cardiac researchers led by Ottawa scientists has launched groundbreaking clinical trials of a stem cell therapy that helps the heart heal itself.

About 70,000 Canadians have a heart attack each year. While many patients return to health after treatment, others suffer from scarring, which affects the chance of long-term survival.

Scar tissue leads to stretching of the heart and that leads to consequences, including heart failure and early death, says Dr. Duncan Stewart, the CEO and scientific director of the Ottawa Hospital Research Institute and the trials lead principal investigator.

This trial enlists stem cells and their amazing ability to help organs regenerate. The first study participant is Harriet Garrow, 68, who had a heart attack on July 2 at home in Cornwall.

After her heart stopped beating, Garrow was resuscitated by paramedics and taken to a hospital in Cornwall, then transferred to the University of Ottawa Heart Institute.

She received all available heart attack therapies, including opening up a blocked artery with a balloon catheter, but her heart had still had extensive damage. She agreed to the experimental therapy and had an infusion on July 25.

Like all the participants, Garrow doesnt know if she received stem cells, lab-enhanced stem cells or a placebo. But she notes that on Sunday she walked up the 13 stairs in her home for the first time since her heart attack.

I feel good, she says. Not quite back to normal, but better than last week.

In about a dozen studies on about 2,000 patients, stem cells have already been proven to have modest but promising benefits. The problem is heart attack patients stem cells dont have the same healing powers as those from young, healthy patients, says Stewart.

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Ottawa research team leading study that allows heart to heal itself

America Stem Cell, Inc. Receives FDA Clearance for Its Multi-Center Nationwide Trial

SAN ANTONIO--(BUSINESS WIRE)--

America Stem Cell, Inc. (ASC) announced today it has received clearance from FDA for its Phase I/IIa nationwide multi-center dual-umbilical cord transplantation study evaluating ASC-101 in patients with hematologic malignancies and myelodysplastic syndrome.

ASC-101 is currently undergoing evaluation in a single-center study at The University of Texas MD Anderson Cancer. To date, 12 patients have been enrolled in the study with 9 patients evaluable. On the basis of data obtained in the single-center study, FDA has given approval to proceed with a multi-center trial.

Enhancing umbilical cord stem cell engraftment into bone marrow in the dual cord transplant setting will improve clinical outcomes for patients with serious, life-threatening cancers and other disorders for which hematopoietic stem cell transplant is prescribed, said, Dr. Elizabeth Shpall, MD, Medical Director, Cell Therapy Laboratory and Director, Cord Blood Bank at M.D. Anderson Cancer Center and Study Chair on the ASC-101 Phase I/IIa clinical trial. Dr. Shpall has submitted an abstract to the upcoming American Society of Hematology (ASH) meeting in December describing the clinical results to date with ASC-101.

There is a significant unmet medical need to improve stem cell engraftment into bone marrow for patients undergoing umbilical cord transplantation, and America Stem Cell is committed to filling that need, said Dr. Linda Paradiso, Chief Development Officer at ASC. ASC-101 is a novel enzyme treatment that will potentially transform hematopoietic stem cell transplantation by accelerating patient immune system and platelet recovery, reducing opportunistic infections and other co-morbidities, and improving patient survival.

ASC was founded with the vision to make stem cell transplants safer and more efficacious for patients undergoing cell therapy. The expansion of this trial using ASC-101 in cancer patients undergoing stem cell transplantation is a major step forward in advancing the ASC clinical pipeline, said Lynnet Koh-LeMaire, Chief Executive Officer/Founder of America Stem Cell.

America Stem Cell is commercializing breakthrough platform technologies and products that enable cell-based therapies and immunotherapies across a wide range of indications. ASCs technologies target homing and engraftment of therapeutic cells to sites of ischemia, inflammation and disease for improved clinical efficacy and patient outcomes. The most advanced product (ASC-101), manufactured at Florida Biologix, is currently in PhI/IIa clinical trials for cord blood transplantation. ASCs second wave of products will expand the platform technology to a broad range of cell types and diseases.

About America Stem Cell, Inc.

America Stem Cell is a privately-held biotechnology company based in San Antonio, TX, with offices in San Diego, CA, and is dedicated to the development and commercialization of enabling technologies to enhance and expand the therapeutic potential of stem cell therapies. The key technology platforms (ASC-101 and ASC-102) are designed to improve the homing and engraftment of stem cells to target organs and increase their therapeutic potential for patients in need of hematopoietic stem cell transplantation. Additionally, these technologies have the potential to enhance efficacy in stem cell treatment of inflammation from chemotherapy/radiation, solid tumors, autoimmune diseases, and ischemic diseases including myocardial infarction and stroke. ASC has partnerships and collaborations with Kyowa Hakko Kirin, Spectrum Health Innovations, Florida Biologix, various medical research institutions including The University of Texas M.D. Anderson Cancer Center, Oklahoma Medical Research Foundation, Fred Hutchinson Cancer Center, University of California San Diego, the Sanford-Burnham Institute, Indiana University, Juvenile Diabetes Research Foundation, as well as corporate partnerships. For additional information, please contact Lynnet Koh at 760-612-6277, or view http://www.americastemcell.com.

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America Stem Cell, Inc. Receives FDA Clearance for Its Multi-Center Nationwide Trial