NCT03799718

Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MS

A Phase 2 Open-label Multicenter Study to Evaluate the Safety and Efficacy of Repeated Administration of NurOwn® [Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (NTF), MSC-NTF] Cells in Participants With Progressive MS

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Brainstorm-Cell Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A multidose open-label study with autologous Mesenchymal Stromal Stem Cells Secreting Neurotrophic Factors (MSC-NTF cells) involving 20 participants with progressive MS at multiple investigational study sites.

Detailed description

An open-label study with a single treatment arm involving 20 participants with progressive MS at multiple investigational study sites. After providing informed consent, participants meeting the inclusion and exclusion criteria will be randomized and approximately 4 weeks later will undergo a bone-marrow aspiration (BMA). Each participants will receive three Intrathecal cell transplantations within 16 weeks and will be followed for 12 weeks for safety and efficacy.

Conditions

• Multiple Sclerosis, Chronic Progressive

Interventions

Type	Name	Description
BIOLOGICAL	NurOwn (MSC-NTF cells)	Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors

Timeline

• Start date: 2019-03-13
• Primary completion: 2021-03-11
• Completion: 2021-03-30
• First posted: 2019-01-10
• Last updated: 2023-12-04
• Results posted: 2022-11-14

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study