Hope For The Weak-Hearted

H N Hospital starts stem cell therapy for MI patients

Rita Dutta - Mumbai

Principal investigator Dr V K Shah (right) at H N Hospital’s cath lab

Ushering hope for victims of acute myocardial infarction (severe heart attack), Sir Hurkisondas Nurrotumdas (HN) Hospital has initiated intracoronary autologous bone marrow stem cell transfer for such patients.

The pilot study will include 20 patients, all having faced acute myocardial infarction (MI). Under the study, ten patients will receive stem cell therapy, and the result will be compared to ten other patients, who have not undergone the therapy. The study, which started in June, 2005 and is likely to be completed by June 2006, has already covered seven patients. The project is being funded by Sir Hurkisondas Nurrotumdas Medical Research Society, the research wing of Sir H N Hospital.

"Equal amount of bone marrow is aspirated from the right and left side of the body, a procedure which is conducted in aseptic environment of the OT" - Dr A J Desai, Co-Investigator, H N Hospital

The research is being conducted under the aegis of principal investigator Dr V K Shah, an interventional cardiologist. The co- investigators are haemotologists Dr A J Desai and Dr Mukesh Desai of H N Hospital, radiologist Dr Bhavin Jhankharia and research scientist Dr Vivek Tanavde of Reliance Life Science.

Says Dr V K Shah, “The aim of the study is to check the safety and feasibility of transfusing autologous bone marrow cell transfer into the infarct-related artery after an acute MI and further to see the improvement in left ventricular function at six months follow-up.” The study is based on the presumption that stem cells when injected in infarct-related coronary artery during its repair process develops into cardiac myocytes and improves the blood supply by neoangiogenesis (growth of new vessels). Experience from over 100 patients in three different studies indicate that intra-coronary infusions of autologous bone marrow cells enhances regional wall motion in infarcted area resulting in improved left ventricular ejection fraction of 5 to 15 per cent. He further adds that current therapies like primary angioplasty and thrombolytic therapy may save only five per cent of the myocardium at six months of follow-up. “Stem cell therapy would save another five to ten per cent,” he says emphatically.

Dr V K Shah says that the paracrine (hormonal) effects of the transfused cells may increase neoangiogenesis manifold which may save some of the hibernating myocardium and hypertrophied myocytes in the peri-infarct zone which are otherwise destined to die. The hormonal effects are because of increased cytokines and other growth factors supplied by these cells. The concept of stem cells developing into cardiomyocytes and active contractile elements in human beings is still under study, though sufficient animal data are there to support it.

Patients of acute MI were chosen for this trial as by virtue of its pathobiology, it provides the best microenvironment for the stem cells to home and survive. Besides this, studies show that stem cells can be safely put into the coronary artery after the heart attack without any surgical intervention.

Patients have to necessarily undergo this therapy within 7 to 21 days of heart attack. For the therapy, around 100 ml of bone marrow is aspirated from Iliac crest portion of the patient’s own body by haematologists. Explaining the procedure, Dr A J Desai, says, “Equal amount is aspirated from the right and left side of the body, a procedure which is conducted in aseptic environment of the operation theatre and takes around half an hour. The procedure is done under local anaesthesia.” The collected bone marrow is put in a citrate bag and handed over to Reliance Life Science to isolate mononuclear cells. The lab does the isolation process in a specific environment and gives the count of the total number of cells along with the count of the CD34, CD45 and AC133 markers, which are likely to develop into cardiac myocytes. From 100 ml of bone marrow, around 10 to 12 ml of stem cells can be extracted. Harvesting the cells takes around three to four hours.

On the same day of aspirating the marrow, the patient is taken in the cardiac catheterisation laboratory where coronary angiography is performed and harvested stem cells are injected with a special balloon catheter into the infarct-related coronary artery of the patient. Each injection is of 2 ml, and the procedure takes not more than 30 minutes.

Before a patient undergoes the therapy, he has to undergo a battery of tests: blood test to find his cardiac injury profile, liver function test, renal function test, along with Dobutamine stress test, cardiac MRI, coronary angiography, LV angiography to assess the cardiac function. Holter monitoring of all the patients is conducted at six weeks or as and when necessary on follow up to assess for arrythmias is also done. The tests are repeated at six months after the cell therapy to assess the LV function. Besides, the hospital also does Troponin and CRP levels before and after the cell therapy to assess the safety of the procedure.

The hospital claims that all the procedures had been successful. The patients have to come for a regular follow up after 2 weeks, 6 weeks, 3 months and 6 months of the procedure. Mohammed Ahmed Ansari (51) is one of the patients in the project. Ansari had an acute MI on 14 th October, 2005 and on 25th October he was transfused with stem cell therapy. Speaking to Express Healthcare Management, Ahmed’s son Mohammed Parvez Ansari, says, “My father is doing fine. We do go for regular check-ups.”

Before initiating the project, the hospital had obtained permission from ethics committee and scientific committee of the hospital. The committee chose autologous bone marrow stem cells because of absence of rejection phenomenon. Embryonic stem cells were ruled out, as there are ethical issues associated with it. The committee also laid down that consent of two relatives apart from the patient is mandatory for the procedure.

Last year, the All India Institute of Medical Sciences (AIIMS) started stem cell therapy for cardiac patients. “Ours is different from AIIMs as there is done surgically and our non-surgically,” says Dr Shah.

The research has evoked mixed response from cardiologists. Taking a critical view, Dr Sudhir Vaisnav, interventional cardiologist says, “Before stem cell therapy in practiced in day to day clinical work, it is important to look at various ways of acquiring stem cells, from bone marrow or skeletal tissue and to conduct more randomised trials.”

When asked why cardiac hospitals in the country do not evince a keen interest in stem cell therapy, he says, “Stem cell research requires logistic support and dedicated team of researchers, which many hospitals cannot afford.” He avers that stem cell therapy along with gene therapy is likely to emerge as the leading therapy for cardiac patients in the coming five to seven years.

However, an interventional cardiologist on conditions of anonymity, says, “It is too early to say whether such research is hype or hope. The long-term risks can be tumour formation at the site of therapy, but such concerns have not been scientifically proved. We need to conduct more trials before we can comment on the prospect of stem cell therapy for cardiac patients.”

Views and counter-views apart, it cannot be denied that HN Hospital’s initiative should surely give a fillip to stem cell research in India.

rita_dutta@rediffmail.com