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

August 20, 2010
August 20, 2010
January 2008
February 2010   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating Spinal Cord Injury
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Spinal Cord Injuries
  • Procedure: laminectomy
    surgical laminectomy with glial scar resection
  • Procedure: Intrathecal
    direct into the CSF through lumbar puncture
  • Experimental: Intralesional
    1. Surgical transplantation into the lesion site in chronic patients
    2. Direct intrathecal implantation in acute and subacute patients
    Intervention: Procedure: laminectomy
  • Experimental: intrathecal
    direct into the CSF through lumbar puncture
    Intervention: Procedure: Intrathecal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01186679
ISSL-AuBM-SCI
Yes
Dr.SGA.Rao, Chairman, International Stemcell Services Ltd.
International Stemcell Services Limited
Not Provided
Principal Investigator: Dr.Arvind Bhateja, MCh.Neurosurgery Sita Bhateja Speciality Hospital
International Stemcell Services Limited
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP