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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Intra thecal transplantation of Autologous stem cell \[MNCs\],100millions per dose in 3 divided doses at interval of 10 days.
Chaitanya Hospital
Pune, Maharashtra, India
RECRUITINGImprovement in overall sensory for motor control using Frankel score.
Time frame: 6 month
Improvement in pain sensation and Significant changes in Muscle Tones from base line
Time frame: 6 month
-Improvement in sensory and motor dysfunction using ASIA( American spinal cord injury association ) Scale
Time frame: 6 month
Significant changes in Muscle Tones and Improvement in pain sensation from base line
Time frame: 6 month
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