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

Primary Purpose

Spinal Cord Injury

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Bone marrow derived stem cells
Sponsored by
Max Institute of Neurosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Max Super speciality HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bone marrow derived stem cells

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Significant improvement in the ASIA scores by the assessment motor, sensory and sphincteric function.
Improvement in the functional Independence as measured by Spinal Cord Independence Measure (SCIM III). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ] Improvement in the pain sensation score as measured by Bryce/Ragnarsson SCI pain taxonomy (BR-SCI-PT). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ] Significant Changes in the muscle tone as indicated by Modified Ashworth Scale (MAS). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ] Improvement in the Clinical Outcome Variable Scale (COVS) score. [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]

Full Information

First Posted
November 15, 2012
Last Updated
November 15, 2012
Sponsor
Max Institute of Neurosciences
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1. Study Identification

Unique Protocol Identification Number
NCT01730183
Brief Title
To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury
Acronym
ABSCI
Official Title
To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury (SCI)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Max Institute of Neurosciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bone marrow derived stem cells
Arm Type
Experimental
Arm Description
Autologous Bone Marrow derived Stem Cells(BMSC) transplanted intrathecally into patients with spinal cord injury.
Intervention Type
Other
Intervention Name(s)
Bone marrow derived stem cells
Other Intervention Name(s)
Bone Marrow derived Mononucleated stem cell (BMMNCs)
Intervention Description
Intrathecal administration of autologous bone marrow derived stem cells upto a cell dose of equal or greater than 10(8)BMMNCs.
Primary Outcome Measure Information:
Title
Number of participants with adverse events as a measure of safety and tolerability.
Description
The measure is the number of adverse events following intrathecal administration of autologous bone marrow derived stem cells in spinal cord injury patients.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Significant improvement in the ASIA scores by the assessment motor, sensory and sphincteric function.
Description
Improvement in the functional Independence as measured by Spinal Cord Independence Measure (SCIM III). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ] Improvement in the pain sensation score as measured by Bryce/Ragnarsson SCI pain taxonomy (BR-SCI-PT). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ] Significant Changes in the muscle tone as indicated by Modified Ashworth Scale (MAS). [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ] Improvement in the Clinical Outcome Variable Scale (COVS) score. [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yashbir Dewan, MS, MCh
Phone
+91-8800255922
Email
dr.ydewanneuro@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yashbir Dewan, MS, MCh
Organizational Affiliation
Max Healthcare
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yashbir Dewan, MS, MCh
Organizational Affiliation
Max Helathcare
Official's Role
Study Chair
Facility Information:
Facility Name
Max Super speciality Hospital
City
Dehradun
State/Province
Uttrakhand
ZIP/Postal Code
248001
Country
India
Individual Site Status
Recruiting
Facility Contact:
Phone
+91-8800255922
Email
dr.ydewanneuro@gmail.com
First Name & Middle Initial & Last Name & Degree
Yashbir Dewan, MS, MCh

12. IPD Sharing Statement

Citations:
PubMed Identifier
19364066
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.
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To Study the Safety and Efficacy of Autologous Bone Marrow Stem Cells in Patients With Spinal Cord Injury

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