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

NCT01186679 | Completed Phase 1 DMC

• 1 other identifier: ISSL-AuBM-SCI
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants with adverse events as a measure of safety and tolerability. Significant clinical improvement in ASIA impairment scale and general condition

  American Spinal Injury Assessment scale of A,B,C,D or E

  18 months

Secondary Outcomes (1)

• Changes in the MRI, Neurological improvement (cranial/spinal reflexes) and evoked potentials study

  18 months

Study Arms (2)

Intralesional

EXPERIMENTAL

1. Surgical transplantation into the lesion site in chronic patients 2. Direct intrathecal implantation in acute and subacute patients

Procedure: laminectomy

intrathecal

EXPERIMENTAL

direct into the CSF through lumbar puncture

Procedure: Intrathecal

Interventions

laminectomy PROCEDURE

surgical laminectomy with glial scar resection

Intralesional

Intrathecal PROCEDURE

direct into the CSF through lumbar puncture

intrathecal

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Stemcell Services Limited: lead

Study Sites (1)

Sita Bhateja Speciality Hospital

Bangalore, Karnataka, 560025, India

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Laminectomy; Injections, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures; Injections; Drug Administration Routes; Drug Therapy

Study Officials

• Dr.Arvind Bhateja, MCh.Neurosurgery

  Sita Bhateja Speciality Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: August 23, 2010
• Study Start: January 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 23, 2010

Record last verified: 2010-08

Locations

IN (1)