To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury

NCT01730183 | Unknown Phase 1

• 1 other identifier: TPSC/POC/BMSC/SCI
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events as a measure of safety and tolerability.

  The measure is the number of adverse events following intrathecal administration of autologous bone marrow derived stem cells in spinal cord injury patients.

  18 months

Secondary Outcomes (1)

• Significant improvement in the ASIA scores by the assessment motor, sensory and sphincteric function.

  18 months

Study Arms (1)

Bone marrow derived stem cells

EXPERIMENTAL

Autologous Bone Marrow derived Stem Cells(BMSC) transplanted intrathecally into patients with spinal cord injury.

Other: Bone marrow derived stem cells

Interventions

Bone marrow derived stem cells OTHER

Intrathecal administration of autologous bone marrow derived stem cells upto a cell dose of equal or greater than 10(8)BMMNCs.

Also known as: Bone Marrow derived Mononucleated stem cell (BMMNCs)

Bone marrow derived stem cells

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Max Institute of Neurosciences: lead

Study Sites (1)

Max Super speciality Hospital

Dehradun, Uttrakhand, 248001, India

RECRUITING

Related Publications (1)

• 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.

  PMID: 19364066 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Yashbir Dewan, MS, MCh

  Max Healthcare

  PRINCIPAL INVESTIGATOR

• Yashbir Dewan, MS, MCh

  Max Helathcare

  STUDY CHAIR

Central Study Contacts

Yashbir Dewan, MS, MCh

CONTACT

+91-8800255922; dr.ydewanneuro@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neurosurgeon

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 21, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 21, 2012

Record last verified: 2012-11

Locations

IN (1)