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

Sponsor

International Stemcell Services Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT01186679

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries	Procedure: laminectomy Procedure: Intrathecal	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intralesional Surgical transplantation into the lesion site in chronic patients 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

Arm

Intervention/Treatment

Experimental: Intralesional

Surgical transplantation into the lesion site in chronic patients 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

Outcome Measures

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 [18 months]
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 [18 months]
MRI findings of the lesion, Nerve conduction studies of the region and somatosensory evoked potentials of the same region

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Must be able to give voluntary (patients may not be able to write) consent.
Must be able to understand study information provided to him.
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.
The level of spinal cord injury must be between C4 and T12(neurological level)
Spinal cord injury categorized in terms of ASIA Impairment scale.
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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01186679

Other Study ID Numbers:

ISSL-AuBM-SCI

First Posted:

Aug 23, 2010

Last Update Posted:

Aug 23, 2010

Last Verified:

Aug 1, 2010

Additional relevant MeSH terms:

Spinal Cord Injuries

Wounds and Injuries

Study Results

No Results Posted as of Aug 23, 2010