LifeCell, a pioneer in cord blood banking in the country, has commenced clinical trials on Critical Limb Ischemia. The trials are being conducted by its dedicated stem cell research arm, 'TRICell', which is located within the Sri Ramachandra University and Hospital at Chennai. Around 60 patients have been enrolled for the trial, which spans for a period of two years.

The company has received an approval from US FDA and the Drugs Control General of India (DCGI) to conduct a clinical trial in Critical Limb Ischemia (CLI) using stem cell therapy.

The trial is intended to offer a novel therapy to patients diagnosed with Critical Limb Ischemia, who have exhausted all surgical and endovascular options for treatment. TriCell has enrolled around 60 volunteers this year, who have Critical Limb Ischemia and are currently being treated by Dr Vijayaraghavan, head of the department of Vascular Surgery, Sri Ramachandra Hospital.

This is the first trial done on these patients with CLI using bone marrow stem cells. The patients are seeing good improvement in condition after the treatment, which has been going on for the last 4-5 months, according to Dr Vijayaraghavan.

This clinical study will evaluate the safety and effectiveness of treating lower limbs of patients diagnosed with CLI due to peripheral arterial occlusive disease (PAOD) with a concentrate of nucleated cells from bone marrow aspirate. The study will evaluate the hypothesis that this concentrate of cells, prepared from bone marrow aspirate, when injected intramuscularly in areas of ischemia in the lower extremity, has the potential to generate collateral vessels, improve perfusion within the ischemic limb and may reduce the potential for amputation.

The scientific literature has reported several studies demonstrating the therapeutic potential of autologous adult stem cells derived from bone marrow. However, there has not been a randomized controlled study to support these preliminary findings. In addition, there has not been a point of care method for concentrating the bone marrow in order to allow the aspiration of marrow and treatment to occur as part of the same procedure. We are pleased to participate in such a groundbreaking study and we are soliciting individuals who might to be considered as subjects in the trial, added Dr Vijayaraghavan.

Inclusion criteria of patients are those who have been diagnosed Critical Limb Ischemia, with existence of a PAOD with clinical presentation corresponding to Rutherford Category 4 and Category 5 as defined in the reporting standards adopted by the Society of Vascular Surgeons.

Further, the patient should have at least one criteria in the study limb like an ankle artery occlusion pressure absolute <40 mmHg or ABI <0.6, or toe artery occlusive pressure < 40mm Hg; or a TcPO2 <30 mmHg lying down.

The TriCell stem cell therapy and research centre set up at an investment of Rs 5 crore and was inaugurated by former President of India Abdul Kalam in November 2007. LifeCell International is India's first & largest umbilical cord blood stem cell bank incepted in November 2004. It has over 12,000 parents who have stored their child's umbilical cord stem cells.