Stem Cell Therapy for Amyotrophic Lateral Sclerosis
Phase 2
Withdrawn
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Biological: Stem cell
- Registration Number
- NCT01984814
- Lead Sponsor
- Neurogen Brain and Spine Institute
- Brief Summary
The effect of autologous bone marrow mononuclear cells on duration of survival in Amyotrophic Lateral Sclerosis patients.
- Detailed Description
Survival duration in Amyotrophic Lateral Sclerosis patients who received cellular transplantation was compared to patients who did not receive cellular transplantation. Kaplan-Meier survival analysis was used for this comparison.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients with the diagnoses of definite amyotrophic lateral sclerosis.
- Clear information about date of onset of symptoms, documented contact information and follow up information
Exclusion Criteria
- Patients with diagnoses of Progressive Lateral sclerosis, Progressive bulbar plasy, Progressive spinal muscular atrophy, Progressive muscular atrophy, monomelicamyotrophy or madras motor neuron disease.
- patients with co-morbidities like presence of acute infections such as Human Immunodeficiency Virus/Hepatitis B Virus/Hepatitis C Virus, malignancies, bleeding tendencies, renal failure, severe liver dysfunction and other acute medical conditions such as respiratory infection and pyrexia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stem cell Stem cell Autologous bone marrow mononuclear cells intrathecal and intramuscular transplantation
- Primary Outcome Measures
Name Time Method Duration of survival 56 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Neurogen brain and spine institute
🇮🇳Mumbai, Maharashtra, India