Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Spinal Cord Injury

Study Overview
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Brief Summary
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This Study is a single arm,Phase I/II , single centre trial to check active comparing the safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be conducted for 36 months.

Detailed Description
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A spinal cord injury (SCI) refers to any injury to the spinal cord that is caused by trauma instead of disease.[1] Depending on where the spinal cord and nerve roots are damaged, the symptoms can vary widely, from pain to paralysis to incontinence.[2][3] Spinal cord injuries are described at various levels of incomplete, which can vary from having no effect on the patient to a complete injury which means a total loss of function.Injuries at any level can cause:Increased muscle tone (spasticity),Loss of normal bowel and bladder control (may include constipation, incontinence, bladder spasms),Numbness,Sensory changes Pain,Weakness, paralysis. This Study is a single arm,Phase I/II , single centre trial to check active comparing the safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be conducted for 36 months.

Official Title
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Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Spinal Cord Injury . It is Self Funded (Patients' Own Funding) Clinical Trial

Conditions
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Spinal Cord Injury.

Intervention / Treatment
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* Biological: Transplantation of Autologous stem cell [MNCs] .


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient should suffer from Spinal cord injury. willingness to undergo bone marrow derived autologous cell therapy. patient those provide fully Informed consent form for the study. Ability and willingness to regular visit to hospital and follow up during the protocol Procedures. traumatic Injury of spinal cord with complete or partial damage by MRI and Spinal cord injury level should be below C4 Exclusion Criteria: Patient with pre- existing or current systemic disease such as Lung, liver,(exception:history of uncomplicated hepatitis A)gastrointestinal,cardiac , immunodeficiency(HIV) History of life threatening allergic or immune - mediated reaction. haemodynamically unstable patients. patient suffer from peripheral muscular dystrophy. lactating and pregnant woman alcohol drug abuse /dependence positive test result for hepatitis A and Hepatitis B OR C Major-traumatic brain injury and patient with psychiatric illness .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: stem cell [ MNCs ]<br>transplantation of autologous stem cell [MNCs ] | Biological: Transplantation of Autologous stem cell [MNCs] .<br>* Intra thecal transplantation of Autologous stem cell [MNCs],100millions per dose in 3 divided doses at interval of 10 days.<br>* Other names: Autologous stem cell[MNCs] .;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in overall sensory for motor control using Frankel score. |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in pain sensation and Significant changes in Muscle Tones from base line |  | 6 month | 
| -Improvement in sensory and motor dysfunction using ASIA( American spinal cord injury association ) Scale |  | 6 month | 
| Significant changes in Muscle Tones and Improvement in pain sensation from base line |  | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injury stem cell