First Generation Stem Cell Therapies Moving Through Trials

Stem cell therapies based on comparatively uncomplicated transplants of cells - either grown from the patient's own tissue or from donors - are still working their way through trials in the more regulated parts of the world, and will be for years yet. For wider access to these therapies, one has to look to medical tourism and reputable clinics overseas. So far these therapies usually result in modest or better improvements over presently available treatment options. Here is an example:

Critical limb ischemia (CLI) is a vascular disease affecting lower limbs, which is going to become a demanding challenge because of the aging of the population. Despite advances in endovascular therapies, CLI is associated with high morbidity and mortality. Patients without direct revascularization options have the worst outcomes. To date, 25%-40% of CLI patients are not candidates for surgical or endovascular approaches, ultimately facing the possibility of a major amputation.

This study aimed to assess the safety and efficacy of autologous bone marrow (BM) [stem cell] transplantation performed in "no-option" patients, in terms of restoring blood perfusion by collateral flow and limb salvage. A multicenter, prospective, not-controlled phase II study for no-option CLI patients was performed. Patients were subjected to intra-arterial infusion of autologous bone marrow and followed for 12 months after the treatment.

Sixty patients were enrolled and treated with BM transplantation, showing improvement in objective and subjective measures of perfusion. Furthermore, survival analysis demonstrated improved amputation-free survival rates at 12 months after the treatment.



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