The first patient has been enrolled in a Phase 2 multicenter clinical trial testing the use of NurOwn cellular therapy to treat progressive multiple sclerosis (MS), BrainStorm Cell Therapeutics announced.
The open-label trial (NCT03799718), titled Safety and Efficacy of Repeated Administration of neuron (MSC-NTF Cells) nin Participants With Progressive MS, will enroll and treat up to 20 adults with progressive MS at multiple investigational study sites. Both primary progressive MS (PPMS) and secondary progressive MS (SPMS) patients are eligible.
Autologous cellular therapy — the transplant of stem cells removed from a patient, grown or modified, and put back into that same patient — is emerging as a credible and practical treatment option for cancer and other highly debilitating diseases, including neurodegenerative diseases.
The idea behind BrainStorm’s NurOwn cellular technology is to take mesenchymal bone marrow stromal cells (MSCs) from patients with a neurodegenerative disease, and modify them to become able to produce neurotrophic factors — biomolecules that support the growth, survival, and maturation of brain cells.
These bone marrow-derived MSCs are expanded and modified outside the patient, referred to as MSC-NTFs or NurOwn cells. The company aims to use this therapy approach to target disease pathways important in neurodegenerative disorders, including MS, amyotrophic lateral sclerosis (ALS), and Huntington’s disease.
Autologous MSC-NTFs have been shown to effectively deliver multiple neurotrophic factors and immunomodulatory signaling molecules directly to the site of damage. The goal in patients is to ultimately slow or stabilize disease progression.
“We are pleased to announce the first participant with progressive MS has been enrolled in our Phase 2 clinical trial,” Chaim Lebovits, president and CEO of BrainStorm, said in a press release.
“Progressive MS has deeply affected the lives of many and dramatically impacted family members, caregivers and others. Today, there is no U.S. FDA approved therapy addressing more than one progressive form of MS and we are pleased to deploy our NurOwn technology platform in this new indication,” Lebovits added.
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