Safety and Efficacy of Stem Cell Therapy in Spinal Cord Injury
Phase 1
Withdrawn
- Conditions
- Spinal Cord Injury
- Interventions
- Biological: Autologous bone marrow mononuclear cell transplantation
- Registration Number
- NCT02027246
- Lead Sponsor
- Neurogen Brain and Spine Institute
- Brief Summary
The aim of this study was to study the effect of stem cell therapy on common symptoms of spinal cord injury patients.
- Detailed Description
Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by standard rehabilitation therapy.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Diagnosed cases of any type of chronic Spinal cord injury
- Age above 6 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
- other acute medical conditions such as respiratory infection
- pregnancy and lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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 6 months clinical symptoms were assessed based on the observation of the experts
- Secondary Outcome Measures
Name Time Method Functional Independence Measure (FIM) 6 months Functional Independence Measure (FIM) is a standard scale performed before and 6 months after the intervention to measure the functional ability of the patients.
Trial Locations
- Locations (1)
Neurogen brain and spine institute
🇮🇳Mumbai, Maharashtra, India