First US Patient Dosed With Investigational Stem Cell Therapy IMS001 for MS

The first US patient has been dosed with an investigational stem cell therapy called IMS001, for multiple sclerosis (MS).

ImStem Biotechnology, the therapy’s developer, announced in a press release that the first patient had been dosed in their phase 1 clinical trial (NCT04956744).

IMS001’s safety, tolerability, and exploratory effectiveness are being investigated for patients with relapsing-remitting, secondary, or primary progressive MS who were unresponsive to prior disease-modifying treatments.

IMS001 is an experimental therapy comprised of human embryonic stem cell-derived mesenchymal stem cells (hES-MSC) and created through a proprietary method using a trophoblast intermediate stage (termed T-MSC).

“IMS001 has demonstrated preclinical immunomodulatory and [blood-brain-barrier] repair activities, which may lead to potential therapeutic benefits in a wide array of neurological, autoimmune, and rare orphan diseases with high unmet medical needs,” the company said in a press release.

“As a scientific advisor to ImStem Biotechnology, it is encouraging to see this T-MSC technology advance into the clinical stage of development where it may fulfill unmet needs for patients with MS,” Jeffrey Cohen, MD, director of the experimental therapeutics program at Cleveland Clinic Mellen Center for Multiple Sclerosis Treatment and Research in Ohio said.

The patient received their single intravenous dose of IMS001 at the Shepherd Center in Atlanta, Georgia. The study plans to enroll up to 30 patients to receive either a low or high dose of IMS001. Patients will be monitored for 60 months to record the frequency of treatment-emergent adverse events and any clinically significant laboratory abnormalities.

Additional clinical sites will include Rocky Mountain MS Clinic in Salt Lake City, Utah, and the University of Massachusetts Memorial Medical Center in Amherst.

“On behalf of our research team, we are excited to have been the first site in the US to dose an MS patient in their ongoing clinical trial with IMS001,” Ben Thrower, MD, from the Shepherd Center said.

ImStem was cofounded by Xiaofang Wang, MD, PhD, chief technology officer, and Ren-He Xu, MD, PhD, former director of the University of Connecticut Stem Cell Institute. The company is part of the University of Connecticut’s Technology Incubation Program.