NCT04681118

Expanded Access Protocol: Repeated Administration of Nurown® (Autologous MSC-NTF Cells) for the Treatment of ALS

Intermediate-size Patient Population Expanded Access Protocol: Repeated Administration of Nurown® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors) for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Brainstorm-Cell Therapeutics · Industry
• Sex: All
• Age: 18 Years – 63 Years
• Healthy volunteers: —

Summary

Expanded Access for treatment with investigational product MSC-NTF cells(NurOwn®) for participants who completed all scheduled treatments and follow-up assessments in the BCT-002-US study

Detailed description

This is an Intermediate-size patient population Expanded Access Protocol (EAP) to provide NurOwn® (MSC-NTF cells) for eligible ALS participants who completed the BCT-002-US phase 3 ALS clinical trial and have received all three IT treatments. The participants will undergo up to three intrathecal (IT) treatments with NurOwn® (MSC-NTF cells). In the first treatment period, the participant received up to three intrathecal (IT) treatments with NurOwn® (MSC-NTF cells) at T1, T2 and T3 and was followed for 12 weeks after the third treatment. In the second treatment period, the participant will receive up to three intrathecal (IT) treatments with NurOwn® (MSC-NTF cells) every 8 weeks at T4, T5 and T6. Following the last EAP treatment, the participant will be followed for three additional monthly visits (in-person, if feasible, or by telephone call or telemedicine in consideration of the ongoing COVID-19 pandemic) through the final protocol visit, during which the ALSFRS-R and safety assessments will be collected

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	NurOwn (MSC-NTF cells)	Intrathecal administration

Timeline

• First posted: 2020-12-23
• Last updated: 2024-04-23

Locations

5 sites across 1 country: United States