The Department of Neurology, All India Institute of Medical Sciences (AIIMS), is planning to conduct a multi centric phase II study on using stem cell therapy in patients with acute ischemic stroke soon.
The study will be the first human trial to determine and compare the favourable and unfavourable effects of bone marrow mononuclear cells (BMMC) in the disease, according to sources.
The institute is currently looking for a Contract Research Organisation (CRO) to conduct the study in five potential sites in the country within a period of two years. The project, supported by Department of Biotechnology is to study the safety, feasibility and efficacy of using intravenous autologous BMMC in patients with acute ischemic stroke.
The department has already completed a pilot study of one year and is planning to conduct the second phase with the help of CROs as an extension, it is learnt. Though there would be five centres to initiate the study, more number of sites may add in later stages, considering their compatibility with certain well-defined eligibility criteria.
The study, which would also marked as the first multi-centric study with the phase II study will aim to determine the dose response gradient of stem cell therapy and to explore if there is favourable risk to benefit ratio for stem cell therapy in patients with the particular disease.
The department has issued letters to various CROs across the country, for hiring services for the project. The study has to measure a number of safety and efficacy variables within various stages of study and the project will also help the institution to justify a phase III study.
However, when contacted, the AIIMS officials refused to reveal more on the project pointing the confidentiality of its research projects till the result is published.