Status:
TERMINATED
A Study of STRO4 in Patients Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
New England Cell Therapeutics, Inc.
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study intends to evaluate the safety and efficacy of STR04 administered intravenously in participants with Amyotrophic Lateral Sclerosis.
Detailed Description
This study is a 69 week open label study of autologous bone-marrow-derived mesenchymal stem cells (STR04) in participants with ALS. Participants will undergo a screening visit, followed by collection...
Eligibility Criteria
Inclusion
- Inclusion:
- "Definite" or "Probable" ALS according to the Revised El Escorial criteria (Airlie House)
- ALS severity grade 1 or 2 according to the Japan ALS severity classification.
- ALSFRS-R scores of 2 or more for all items, with scores of 4 for all breathing- related items (i.e., dyspnea, orthopnea, respiratory insufficiency).
- Within 2 years of ALS onset.
- %FVC of 80% or more.
- Aged 18 to ≤75 years at the time of informed consent.
- Exclusion:
- Current Viral Infection (e.g. HBV, HCV, HIV, HTLV-1, HPVB19, syphilis, COVID- 19).
- Current low blood cell counts
- History of cancer, congenital malformations, or chromosomal abnormalities
- History of allergy to penicillin or streptomycin, or other serious allergies.
- Current poor medical condition, due to endocrine disease, metabolic disease, immune disease, blood disease, psychiatric disorders, neurological diseases, cardiovascular diseases, respiratory diseases, gastrointestinal diseases, musculoskeletal or connective tissue diseases, renal or urogenital diseases.
- History of intracranial lesions, or stenosis, dissection or severe atherosclerotic disease of a blood vessel in the head or neck.
- Current uncontrolled hypertension.
- Prior treatment with a cell or gene therapy.
- Currently participating in any other clinical trial.
- Women who are pregnant, breastfeeding, or plan to become pregnant during study participation
- Men with plan for their partner to become pregnant during study participation.
Exclusion
Key Trial Info
Start Date :
August 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2025
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT06910384
Start Date
August 12 2025
End Date
December 16 2025
Last Update
December 18 2025
Active Locations (1)
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1
National Neuromuscular Research Institute
Austin, Texas, United States, 78759