Status:
COMPLETED
Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients
Lead Sponsor:
Brainstorm-Cell Therapeutics
Collaborating Sponsors:
California Institute for Regenerative Medicine (CIRM)
Conditions:
Amyotrophic Lateral Sclerosis (ALS)
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
This study will evaluate the safety and efficacy of repeated administration of NurOwn® (MSC-NTF cells) therapy, which is based on transplantation of autologous bone marrow derived mesenchymal stromal ...
Detailed Description
Neurotrophic factors (NTFs) are potent survival factors for embryonic, neonatal, and adult neurons and are considered potential therapeutic candidates for ALS. Delivery of multiple NTFs to the immedia...
Eligibility Criteria
Inclusion
- ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria.
- Having onset of ALS disease symptoms, including limb weakness within 24 months at the Screening Visit.
- ALSFRS-R ≥ 25 at the screening Visit.
- Upright slow vital capacity (SVC) measure ≥ 65% of predicted for gender, height, and age at the screening Visit.
- Rapid progressors
- Participants taking a stable dose of Riluzole are permitted in the study
- Citizen or permanent resident of the United States or Canadian citizen able to travel to a US site for all follow-up study visits
Exclusion
- Prior stem cell therapy of any kind
- History of autoimmune or other serious disease (including malignancy and immune deficiency) that may confound study results
- Current use of immunosuppressant medication or anticoagulants (per Investigator discretion)
- Exposure to any other experimental agent or participation in an ALS clinical trial within 30 days prior to Screening Visit
- Use of RADICAVA (edaravone injection) within 30 days of screening or intent to use edaravone at any time during the course of the study including the follow up period
- Use of non-invasive ventilation (BIPAP), diaphragm pacing system or invasive ventilation (tracheostomy)
- Feeding tube
- Pregnant women or women currently breastfeeding
Key Trial Info
Start Date :
August 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2020
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT03280056
Start Date
August 28 2017
End Date
September 29 2020
Last Update
February 29 2024
Active Locations (6)
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1
University of California Irvine Alpha Stem Cell Clinic
Irvine, California, United States, 92697
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
California Pacific Medical Center
San Francisco, California, United States, 94115
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115