Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The projected data related to the burden of spinal cord injuries induced limb paralysis in India is quite alarming. This is attributed to the rapid industrialization and economical development in the country. Increase in vehicular traffic has caused numerous road traffic accidents. Rapid increase in populations, development in the computer technology and real estate business lead to construction of huge buildings which indirectly adds to the injuries due to fall. Spinal cord injuries could not be treated adequately with the prevailing treatment modalities. In view of this, there is definitely an urgent need for finding different methods of treatment for these patients who cannot undergo established modalities of treatment or these have been tried unsuccessfully. Since a large number of these patients will loose their productive life and at the prime of their lives, one such alternate therapy, which seems to offer some promise, is "stem cell" therapy, which has been well studied and published in prestigious journals.
In our present study, we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells surgically transplanted directly into the lesion site with glial scar resection for 8 indian patients of chronic spinal cord injury and intra-thecal injection for 4 indian patients of acute and subacute injury.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralesional | Experimental |
|
|
| intrathecal | Experimental | direct into the CSF through lumbar puncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laminectomy | Procedure | surgical laminectomy with glial scar resection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with adverse events as a measure of safety and tolerability. Significant clinical improvement in ASIA impairment scale and general condition | American Spinal Injury Assessment scale of A,B,C,D or E | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the MRI, Neurological improvement (cranial/spinal reflexes) and evoked potentials study | MRI findings of the lesion, Nerve conduction studies of the region and somatosensory evoked potentials of the same region | 18 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr.Arvind Bhateja, MCh.Neurosurgery | Sita Bhateja Speciality Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sita Bhateja Speciality Hospital | Bangalore | Karnataka | 560025 | India |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D007796 | Laminectomy |
| D007278 | Injections, Spinal |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D019299 | Decompression, Surgical |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intrathecal |
| Procedure |
direct into the CSF through lumbar puncture |
|
| D014947 | Wounds and Injuries |
| D019635 | Neurosurgical Procedures |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |