Research and Development

Celvive, Inc. has developed a new approach, using a closed bag system to isolate specific adult stem cells from the patients' own bone marrow. This strategy supports the use of specific autologous cells, displaying the desired multipotency and secretory profiles to enhance SCI regeneration. Celvive has generated a closed system (The StemCell bag™) that consists of sterile, single-use disposable sets of bags and attachments connected to a microprocessor-controlled instrument to enable the isolation of matrix stem cells in a functionally closed system. These autologous stem cells are separated in the StemCell® bag can be injected back into the patient via intrathecal injections.

We have very promising data with this therapy in experimental in vivo models. These in vivo preclinical studies of SCI model revealed that stem cells homed to the injury site, and resulted in spared white and gray matter, with remyelination, neural regeneration, functional improvement, and importantly, with no side effects observed. Importantly the concept has been tested in an overseas randomized controlled phase I/II clinical trial in humans including 70 chronic SCI patients. Data from these studies indicate the safety and efficacy of intrathecal autologous stem cell therapy. The results from this clinical trial study is published in the cell transplantation journal: click here to view

Celvive has partnered with a US-based FDA-Certified manufacturer to produce the StemCell bag™ system under GMP conditions. These bags will be tested for efficacy of isolating the desired stem cells and in toxicological studies with two in vivo models to generate the neccissary data for an IND application with FDA.