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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stem cell [ MNCs ] | Other | transplantation of autologous stem cell [MNCs ] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transplantation of Autologous stem cell [MNCs] . | Biological | Intra thecal transplantation of Autologous stem cell [MNCs],100millions per dose in 3 divided doses at interval of 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in overall sensory for motor control using Frankel score. | 6 month |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| sachin S Jamadar, Dortho | Contact | +918888788880 | sac2751982@gmail.com | |
| Smita s Bhoyar, B.A.M.S.PGCR | Contact | 9372620569 | drsmitabhoyar@rediff.com |
| Name | Affiliation | Role |
|---|---|---|
| ANANT E BAGUL, M.S | CHAITANYA HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaitanya Hospital | Recruiting | Pune | Maharashtra | 411009 | India |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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|
| Significant changes in Muscle Tones and Improvement in pain sensation from base line | 6 month |
| D014947 | Wounds and Injuries |