Spinal Cord Injury
Conditions
Keywords
spinal cord injury, stem cell therapy, bone marrow, mononuclear cells, autologous
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.
Interventions
Bone marrow is aspirated by a standard procedure. Mononuclear cells are separated by density gradient method and then injected intrathecally by a standard lumbar puncture procedure
Sponsors
Neurogen Brain and Spine Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in clinical symptoms of spinal cord injury after 6 months | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
India
Outcome results
None listed