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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Procedure: laminectomy; Procedure: Intrathecal

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560025
      • Sita Bhateja Speciality Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the MRI, Neurological improvement (cranial/spinal reflexes) and evoked potentials study	MRI findings of the lesion, Nerve conduction studies of the region and somatosensory evoked potentials of the same region	18 months

Collaborators and Investigators

• Sponsor: International Stemcell Services Limited
• Investigators: Principal Investigator: Dr.Arvind Bhateja, MCh.Neurosurgery, Sita Bhateja Speciality Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: August 20, 2010
• First Submitted That Met QC Criteria: August 20, 2010
• First Posted (Estimate): August 23, 2010

Study Record Updates

• Last Update Posted (Estimate): August 23, 2010
• Last Update Submitted That Met QC Criteria: August 20, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: ISSL-AuBM-SCI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No