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Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating Spinal Cord Injury (ABMST-SCI)

This study has been completed.
Sponsor:
Information provided by:
International Stemcell Services Limited
ClinicalTrials.gov Identifier:
NCT01186679
First received: August 20, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injuries
 Procedure: laminectomy
Procedure: Intrathecal
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Transplantation of Autologous Bone Marrow Stem Cells With Glial Scar Resection for Patients of Chronic Spinal Cord Injury and Intra-thecal Injection for Acute and Subacute Injury - A Preliminary Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by International Stemcell Services Limited:

Primary Outcome Measures:
  • Number of Participants with adverse events as a measure of safety and tolerability. Significant clinical improvement in ASIA impairment scale and general condition [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    American Spinal Injury Assessment scale of A,B,C,D or E


Secondary Outcome Measures:
  • Changes in the MRI, Neurological improvement (cranial/spinal reflexes) and evoked potentials study [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    MRI findings of the lesion, Nerve conduction studies of the region and somatosensory evoked potentials of the same region


Enrollment: 12
Study Start Date: January 2008
Study Completion Date: August 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intralesional
  1. Surgical transplantation into the lesion site in chronic patients
  2. Direct intrathecal implantation in acute and subacute patients
 Procedure: laminectomy
surgical laminectomy with glial scar resection
Experimental: intrathecal
direct into the CSF through lumbar puncture
 Procedure: Intrathecal
direct into the CSF through lumbar puncture

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be able to give voluntary (patients may not be able to write) consent.
  2. Must be able to understand study information provided to him.
  3. Patients with complete spinal cord trans-section: at least post 6 months after spinal cord Injury (in chronic patients), < 2 weeks in acute category and 2-8 weeks in subacute patients.
  4. The level of spinal cord injury must be between C4 and T12(neurological level)
  5. Spinal cord injury categorized in terms of ASIA Impairment scale.
  6. Age should be between 20-55 years

Exclusion Criteria:

  • Mechanical ventilation due to neurological impairment
  • Multiple level trauma
  • Undetermined size and location of Spinal Cord injury
  • Gunshot or other penetrating trauma to the spinal cord
  • Longitudinal dimension of injury by MRI is greater than 3spinal segments
  • Associated severe head injury
  • More than 9cms long bone fracture
  • Women who are pregnant or lactating
  • Serious pre-existing medical conditions
  • Disease or impairment that precludes adequate neurological examination.
  • Should not have co-morbidities like Diabetes, Systemic Hypertension etc.
  • Severe co-morbidities/bed sores Tests positive for infectious diseases Deranged Coagulation profile and Hb < 8mg/dl
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186679

Locations
India
Sita Bhateja Speciality Hospital
Bangalore, Karnataka, India, 560025
Sponsors and Collaborators
International Stemcell Services Limited
Investigators
Principal Investigator: Dr.Arvind Bhateja, MCh.Neurosurgery Sita Bhateja Speciality Hospital
  More Information

No publications provided

Responsible Party: Dr.SGA.Rao, Chairman, International Stemcell Services Ltd.
ClinicalTrials.gov Identifier: NCT01186679     History of Changes
Other Study ID Numbers: ISSL-AuBM-SCI
Study First Received: August 20, 2010
Last Updated: August 20, 2010
Health Authority: India: Indian Council of Medical Research

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013