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Cell Therapy expertise |
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Regenerative Medicine is devoted to treatments in which stem cells are induced to differentiate into specific cell types to repair damaged cell populations or tissues. Clinical studies using stem cell are underway to find new treatment options to orphan diseases.
We have contributed to:
"world's first approved stem cell drug from Osiris® cleared for marketing by Health Canada. Prochymal® offers hope to children suffering from life-threatening Graft vs Host Disease". "Marketing approval in Europe of Harvest-Terumo’s on site stem cell concentrator device" |
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Regenerative Medicine Clinical Trials Pioneer
We have contributed to the evolution of cell therapy clinical research ecosystem in India and Malaysia. Establishment of regulatory pathways, special IRB’s, safety monitoring in cell therapy DSMB are some areas of our contribution.
We have successfully completed 6 Stem Cell studies, 4 studies are in follow-up phase and several studies are in set-up phase or awaiting Health Authority approval. To date we have enrolled nearly 1000 patients in cell therapy studies. We have extensive experience in audits of both sites and CRO for cell therapy studies by Regulators.
Experience
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Consulting Experience
We have been consulted in market access strategy, partnering strategy, funding application apart for developing regulatory pathway and clinical trial design and development plan. |
| Stem Cell Types |
| Umbilical cord blood stem cells |
| Bone marrow (hematopoietic / mesenchymal stem cells) |
| Peripheral Blood |
| Interventions |
| Autologous stem cell therapy – including 2 device studies |
| Allogenic stem cell therapy |
| Therapeutic Areas |
No of Studies |
| Critical limb ischemia |
6 |
| Acute myocardial infarction |
2 |
| Osteoarthritis |
3 |
| Cerebral stroke |
2 |
| Diabetes mellitus type II |
2 |
| Liver cirrhosis, GVHD, CHF-CABG, COPD, cerebral palsy, ischemic cardio myopathy |
1 each |
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