Clinical trial NCT01730183: To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury
Official title: To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury (SCI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injury
Lead sponsor: Max Institute of Neurosciences
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Spinal cord injury (SCI) is a traumatic disorder resulting in a functional deficit that usually leads to severe and permanent paralysis and the projected data related to the burden of spinal cord injuries across the globe is quite alarming. Pharmacological and rehabilitation therapies to SCI have got limited effect. 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. Another promising therapeutic approach for SCI is "Stem cell transplantation". Bone marrow derived stem cells have been shown to promote anatomical and functional recovery in animal models of SCI by promoting tissue sparing, axonal regeneration, and remyelination. In our present study, we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells surgically transplanted intrathecally into patients with spinal cord injury.

Eligibility criteria: Inclusion Criteria:

1. 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 ).
2. Confirmation spinal cord injury level (Patients with complete or partial transection/damage by MRI).
3. Those provide fully informed consent.
4. The level of spinal cord injury must be below C4.

Exclusion Criteria:

1. Spinal vertebral instability.
2. Major concurrent medical illness (e.g. carcinoma, auto-immune disease,)
3. ASIA Impairment Scale category other than D \& E.
4. Lactating and pregnant women.
5. Syringomyelia is also an exclusion criterion but an exemption can be made for a patient with a stable syrinx.
6. Platelet count greater than 100 thousand/µl at screening.
7. Hematocrit less than 30% prior to bone marrow aspiration.
8. Patients with major and current psychiatric illness.
9. Significant traumatic brain injury associated with the spinal cord injury.

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability.
timeFrame: 18 months
Secondary outcomes:
measure: Significant improvement in the ASIA scores by the assessment motor, sensory and sphincteric function.
timeFrame: 18 months
Other outcomes:
Locations:
city: Dehradun
country: India
facility: Max Super speciality Hospital
state: Uttrakhand
Study officials:
affiliation: Max Healthcare
name: Yashbir Dewan, MS, MCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Max Helathcare
name: Yashbir Dewan, MS, MCh
role: STUDY_CHAIR
References:
citation: Geffner LF, Santacruz P, Izurieta M, Flor L, Maldonado B, Auad AH, Montenegro X, Gonzalez R, Silva F. Administration of autologous bone marrow stem cells into spinal cord injury patients via multiple routes is safe and improves their quality of life: comprehensive case studies. Cell Transplant. 2008;17(12):1277-93. doi: 10.3727/096368908787648074.