A Study of STRO4 in Patients Amyotrophic Lateral Sclerosis (ALS)
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Biological: STR04
- Registration Number
- NCT06910384
- Lead Sponsor
- New England Cell Therapeutics, Inc.
- 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 of peripheral blood and bone marrow for the manufacture of STR04. Once manufacturing is successfully completed, participants will have a Baseline visit followed by 4 doses of STR04, one dose every 12 weeks. Participants will have a final assessments 12 weeks after the 4th dose.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm, Open Label STR04 -
- Primary Outcome Measures
Name Time Method Change in Amyotrophic Lateral Sclerosis Functional Rating Scale Score 25 weeks
- Secondary Outcome Measures
Name Time Method Change in Amyotrophic Lateral Sclerosis Functional Rating Scale Score 49 weeks Change in Percent-predicted forced vital capacity (%FVC) From Baseline to 25 weeks and 49 weeks Change in Manual Muscle Test (MMT) From Baseline to 25 weeks and 49 weeks Change in Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) From Baseline to 25 weeks and 49 weeks Change in plasma neurofilament light (NfL) From Baseline to 25 weeks and 49 weeks
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