Stem cell clinics under govt scanner

Those hospitals and medical institutions advertising treatment of incurable diseases with stems cells are now under scanner of the Union Ministry of Health and Family Welfare.

The ministry has already processed complaints against at least 23 website advertisements.

The National Apex Committee for Stem Cell Research and Therapy (NACSCRT), under the Indian Council of Medical Research, has looped in Advertising Standards Council of India (ASCI) to monitor advertisements that claim to fully cure patients with stem cell based therapies.

Several clinics and organisations advertise stem cell therapies whose safety and efficacy are not proven, to attract vulnerable patients. As per the National Guidelines for Stem Cell Research 2013, stem cell therapy has not been proven effective other than in Hematopoietic Stem Cell Transplantation (HSCT) for haematological disorders (disorders which primarily affect the blood).

NAC-SCRT has observed that several clinicians, companies, hospitals advertise stem cell based therapies other than haematopoietic stem cell transplantation for haematological disorders on their websites. Officials clearly say that these therapies are currently investigational and must be conducted only within the scope of clinical trials.

Dr. Alok Srivastava, Chairman, NAC-SCRT said, "Advertisements claiming to offer stem cell-based therapies other than Haematopoietic Stem Cell Transplantations for blood diseases are in violation of the clause 10.3.1 of the National Guidelines for Stem Cell Research-2013."

"Use of stem cells for any other purpose outside the ambit of clinical trials will be against these guidelines and is hence not permissible. We have asked ASCI to review such advertisements and are happy that action has been initiated against 23 such websites. It is necessary that such misleading advertisements be removed and action be taken against the defaulters unless they are suitably modified to clarify the unproven nature of these therapies and are only offered within approved clinical trials. The NAC-SCRT will be reviewing the developments in the field and modifying its position with regard to proven therapies from time to time," he added.

As stem cell-based therapies are currently experimental, advertising these for results not approved by regulatory authorities is in violation of Chapter III of the ASCI code for Self-Regulation of Advertisements. "The code requires that advertisements should not propagate products or services, the use of which is banned under the law," said Narendra Ambwani, Chairman, ASCI.

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Stem cell clinics under govt scanner

How stem cells can fix a broken heart with just one jab

The pioneering treatment involves cells taken from a patients own body Theseare then reinjected into their heart to repair damaged muscle Could improve quality of life for patients suffering from heart failure This is caused by heart failing to pump enough blood around the body at the right pressure

By Roger Dobson and Katherine Keogh For The Mail On Sunday

Published: 17:16 EST, 21 March 2015 | Updated: 18:15 EST, 21 March 2015

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A pioneering treatment that uses stem cells to repair a broken heart could transform the lives of people with a potentially fatal cardiac condition.

The 15-minute procedure involves cells taken from a patients own body, which are then reinjected into their heart to repair damaged muscle.

It is hoped that the procedure could improve the quality of life for patients suffering from heart failure, which affects 900,000 people in the UK.

The condition is caused by the heart failing to pump enough blood around the body at the right pressure, because the muscle has become too weak or stiff to work properly. It causes breathlessness and extreme tiredness, and can even lead to sudden death.

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How stem cells can fix a broken heart with just one jab

The Lancet: Targeted drug doubles progression free survival in Hodgkin lymphoma

A phase 3 trial of brentuximab vedotin (BV), the first new drug for Hodgkin lymphoma in over 30 years, shows that adults with hard-to-treat Hodgkin lymphoma given BV immediately after stem cell transplant survived without the disease progressing for twice as long as those given placebo (43 months vs 24 months).

The findings, published in The Lancet, are potentially practice changing for this young cancer population who have exhausted other treatment options and for whom prognosis is poor.

"No medication available today has had such dramatic results in patients with hard-to-treat Hodgkin lymphoma"*, says lead author Craig Moskowitz, a Professor of Medicine at Memorial Sloan Kettering Cancer Center, New York, USA.

Hodgkin lymphoma is the most common blood cancer in young adults aged between 15 and 35 years. Most patients are cured with chemotherapy or radiotherapy. However, for patients who relapse, or do not respond to initial therapy, the treatment of choice is usually a combination of high-dose chemotherapy and autologous stem cell transplant (ASCT)--a procedure that uses healthy stem cells from the patient to replace those lost to disease or chemotherapy. While about 50% of patients who undergo this procedure are cured, for the other half treatment is palliative.

BV is an antibody attached to a powerful chemotherapy drug that seeks out cancer cells by targeting the CD30 protein on Hodgkin lymphoma cells. BV sticks to the CD30 protein and delivers chemotherapy directly into the cancer cell to kill it. Recently, BV has been approved for relapsed or refractory Hodgkin lymphoma in 50 countries.

In the AETHERA phase 3 trial, Moskowitz and colleagues aimed to establish whether early treatment with BV after ASCT could prevent disease progression. They randomly assigned 329 patients with Hodgkin lymphoma aged 18 or older who were at high risk of relapse or progression after ASCT to 16 cycles of BV infusions once every 3 weeks or placebo.

At 2 years follow up, the cancer had not progressed at all in 65% of BV patients compared with 45% in the placebo group. "Nearly all of these patients who are progression free at 2 years are likely to be cured since relapse 2 years after a transplant is unlikely"*, explains Dr Moskowitz.

BV was generally well tolerated. The most common side effects were peripheral neuropathy (numbness or pain in the extremities due to nerve damage; 67% BV vs 13% placebo) and neutropenia (low white blood count; 35% vs 12%).

According to Dr Moskowitz, "The bottom line is that BV is a very effective drug in poor risk Hodgkin lymphoma and it spares patients from the harmful effects of further traditional chemotherapy by breaking down inside the cell resulting in less toxicity."*

Writing in a linked Comment, Professor Andreas Engert from the University Hospital of Cologne in Germany discusses how best to define which patients are at high risk of relapse and should be treated with BV. He writes, "AETHERA is a positive study establishing a promising new treatment approach for patients with Hodgkin's lymphoma at high risk for relapse. However, with a progression-free survival of about 50% at 24 months in the placebo group, whether this patient population is indeed high risk could be debated...An international consortium is currently reassessing the effect of risk factors in patients with relapsed Hodgkin's lymphoma to define a high-risk patient population in need of consolidation treatment. We look forward to a better definition of patients with relapsed Hodgkin's lymphoma who should receive consolidation treatment with brentuximab vedotin.

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The Lancet: Targeted drug doubles progression free survival in Hodgkin lymphoma

Stem cell therapy may help treat type 2 diabetes

A human embryonic stem cell line derived at Stanford University.(REUTERS/Julie Baker/Stanford University School of Medicine/California Institute for Regenerative Medicine/Handout)

Type 2 diabetes is marked by insulin resistance, or the bodys inability to store sugar and convert it into carbohydrates for energy. Overcoming that resistance is the main hurdle scientists face in creating new treatment for the condition, but researchers in Canada have found a promising means for doing so: combining stem cell therapy and antidiabetic medication.

Type 2 diabetes accounts for nearly 95 percent of the 400 million diabetes cases worldwide. Current treatment involves imprecise insulin injection, and can produce side effects like unwanted weight gain, gastrointestinal issues and low blood glucose levels. Eighty percent of Type 2 diabetes patients are overweight.

In the study, published Thursday in the journal Stem Cell Reports, scientists observed that transplanting human stem cells into mice with Type 2 diabetes symptoms, then administering common antidiabetic drugs, improved the mices glucose metabolism, body weight and insulin sensitivity three hallmark problems associated with the condition.

There have been similar reports looking at treatment of type 1 diabetes by stem cell-based replacement, and there are many people around the world who are interested in that, lead study author Timothy J. Kieffer, a molecular and cellular medicine professor at the University of British Columbia, in Vancouver, told FoxNews.com. Until this point, nobody to our knowledge had tested such a stem cell-based transplant study in a Type 2 diabetes model.

Many [of these studies] have been predicted to fail because one of the characteristics of Type 2 diabetes is insulin resistance, and that is in part due to obesity and higher demands of insulin, Kieffer added, and therefore it might be predicted that insulin replacement wouldnt work if were just putting insulin back.

Researchers fed four separate groups of immunosuppressed mice a different diet to try to emulate humans diagnosed with Type 2 diabetes. One group of mice received a 45 percent fat diet; one a 60 percent fat diet; one a high-fat, Western diet; and the last a low-fat diet. No single group of mice developed a phenotype that exactly mimicked a Type 2 diabetes human patient, but all three high-fat groups ended up exhibiting characteristics that mirrored the hallmark features of the condition.

Study authors transplanted human embryonic stem cell (hESC)-derived pancreatic progenitor cells into the mice after they began exhibiting symptoms. These cells are programmed to expand and differentiate when transplanted into the pancreas, and to subsequently secrete insulin.

To transplant the human stem cells, researchers used a macroencapsulation device, a mechanism that is meant to prevent the body from detecting nonnative material as foreign and subsequently rejecting it. Because the mice were immunosuppressed, the device wasnt necessary, but Kieffer said his team used it so their findings would be more relevant for future clinical trials, wherein the patients would not be immunosuppressed. Researchers opted to induce Type 2 diabetes symptoms in immunosuppressed mice instead of using the mice model genetically engineered to assume Type 2 diabetes for that same reason.

The hope in the field is that some sort of device will eliminate the need for immunosuppression when cells are transplanted, Kieffer said.

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Stem cell therapy may help treat type 2 diabetes