This is a Phase I/II, multicenter, prospective, non-randomized, open label study to evaluate
the safety/efficacy of autologous bone marrow-derived stem cell transplantation in spinal
cord injury patients.
Other: Bone marrow derived stem cells
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Locations near you
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Full eligibility criteria for NCT01730183
Ages eligible for Study
18 Years to 60 Years
Genders eligible for Study
Accepts Healthy Volunteers
Traumatic injury of the spinal cord (below C5 level) occurring within 6 months to 8 years prior to treatment, resulting in a sustained and complete / Partial loss of sensory and motor function below the injury (ASIA Category A, B and C ).
Confirmation spinal cord injury level (Patients with complete or partial transection/damage by MRI).
Those provide fully informed consent.
The level of spinal cord injury must be below C4.
Spinal vertebral instability.
Major concurrent medical illness (e.g. carcinoma, auto-immune disease,)
ASIA Impairment Scale category other than D & E.
Lactating and pregnant women.
Syringomyelia is also an exclusion criterion but an exemption can be made for a patient with a stable syrinx.
Platelet count greater than 100 thousand/µl at screening.
Hematocrit less than 30% prior to bone marrow aspiration.
Patients with major and current psychiatric illness.
Significant traumatic brain injury associated with the spinal cord injury.
All locations for NCT01730183
Max Super speciality Hospital
Dehradun, Uttrakhand, India, 248001
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View full eligibility
Tris trial is registered with FDA with number: NCT01730183. The sponsor of the trial is Max Institute of Neurosciences and it is looking for 15 volunteers for the current phase.
Official trial title: To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury (SCI)
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