Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating Spinal Cord Injury

NCT ID: NCT01186679

Last Updated: 2010-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-08-31

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intralesional

1. Surgical transplantation into the lesion site in chronic patients

2. Direct intrathecal implantation in acute and subacute patients

Group Type: EXPERIMENTAL

laminectomy

Intervention Type: PROCEDURE

surgical laminectomy with glial scar resection

intrathecal

direct into the CSF through lumbar puncture

Group Type: EXPERIMENTAL

Intrathecal

Intervention Type: PROCEDURE

direct into the CSF through lumbar puncture

Interventions

laminectomy

surgical laminectomy with glial scar resection

Intervention Type: PROCEDURE

Intrathecal

direct into the CSF through lumbar puncture

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Stemcell Services Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

International Stemcell Services Ltd.

Principal Investigators

Dr.Arvind Bhateja, MCh.Neurosurgery

Role: PRINCIPAL_INVESTIGATOR

Sita Bhateja Speciality Hospital

Locations

Sita Bhateja Speciality Hospital

Bangalore, Karnataka, India

Countries

India

Other Identifiers

ISSL-AuBM-SCI

Identifier Type: -

Identifier Source: org_study_id