Stem Cell Therapy in Spinal Cord Injury
Phase 2
Withdrawn
- Conditions
- Spinal Cord Injury
- Interventions
- Biological: Autologous bone marrow mononuclear cell transplantation
- Registration Number
- NCT02009124
- Lead Sponsor
- Neurogen Brain and Spine Institute
- Brief Summary
The purpose of this study is to study the effect of stem cell therapy on common symptoms in patients with spinal cord injury.
- Detailed Description
Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by vigorous rehabilitation therapy.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Diagnosed cases of any type of spinal cord injury
- age above 12 months.
Exclusion Criteria
- presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus
- malignancies
- bleeding tendencies
- pneumonia
- renal failure
- severe liver dysfunction
- severe anemia [Hemoglobin < 8]
- any bone marrow disorder
- space occupying lesion in brain
- 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 Autologous bone marrow mononuclear cell transplantation autologous bone marrow mononuclear cell transplantation
- Primary Outcome Measures
Name Time Method Change in clinical symptoms of spinal cord injury after 6 months 6 months
- Secondary Outcome Measures
Name Time Method Functional independence measure (FIM) 6 months It is a standard objective scale used for functional evaluation of the spinal cord injury patients. Its reliability and validity has been well established. It will be marked by a certified occupational therapy expert before the intervention and 6 months after the intervention.
Trial Locations
- Locations (1)
Neurogen brain and spine institute
🇮🇳Mumbai, Maharashtra, India