The Evaluation of the Effect of Mesenchymal Stem Cells on the Immune System of Patients With ALS
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Amyotrophic Lateral Sclerosis
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Clinical Phase: I/II Population: Patients with Amyotrophic Lateral Sclerosis. Project Design: One arm, non-blinded, open label study Planned Sample Size: 20 patients Investigational Medicinal Product: active IMP - mesenchymal stem cells isolated from Wharton's jelly Screening: Three visits on site t...
Clinical Phase: I/II Population: Patients with Amyotrophic Lateral Sclerosis. Project Design: One arm, non-blinded, open label study Planned Sample Size: 20 patients Investigational Medicinal Product: active IMP - mesenchymal stem cells isolated from Wharton's jelly Screening: Three visits on site to check the eligibility criteria (around 90, 60 and 30 days before first IMP administration) Treatment (IMP administration): Each patient will receive IMP three times: on baseline (day 0), 30 and 60 days after baseline (+/- 7 days). Administration route: intrathecal Follow up: Duration: 18 months after first IMP administration Four on-site visits (3, 6, 9, 12 months after first IMP administration) and seven phone visits (4, 5, 7, 8, 10, 11 and 18 months after first IMP administration)
Tracking Information
- NCT #
- NCT04651855
- Collaborators
- National Center for Research and Development, Poland
- Investigators
- Not Provided