Status:
COMPLETED
Repeated Mesenchymal Stem Cell Injections in ALS
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
An open-label, single-center clinical trial to evaluate the safety and efficacy of repeated intrathecal administrations of autologous bone marrow derived mesenchyme stem cells in ALS patients. The stu...
Detailed Description
An open-label, single-center clinical trial to evaluate the safety and efficacy of repeated intrathecal administrations of autologous bone marrow derived mesenchyme stem cells in ALS patients. The stu...
Eligibility Criteria
Inclusion
- Males and females ages 18 to 70 years old, at the Screening Visit.
- Sporadic or familial ALS diagnosed patients fulfilling the El Escorial clinical criteria for definite.
- Capable of providing informed consent and willing and able to follow study procedures, including willingness to undergo multiple/repeated lumbar punctures.
- ALSFRS-R ≥15 at the Screening Visit.
Exclusion
- Patients with severe cognitive decline or inability to understand and sign the informed consent.
- Participation in another clinical trial within 1 year prior to start of the study
- Patients with active infections.
- Positive test for Hepatitis B, Hepatitis C, and/or HIV per laboratory evaluations at the screening visit.
- Any history of solid malignancy including any malignancy affecting the central nervous system within 5 years of the Screening Visit
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04821479
Start Date
January 1 2016
End Date
December 31 2020
Last Update
March 29 2021
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