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NCT Number: NCT01186679

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

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.

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Key information

Conditions

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

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sita Bhateja Speciality Hospital

Bangalore, Karnataka, 560025, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laminectomy

Procedure

surgical laminectomy with glial scar resection

Intrathecal

Procedure

direct into the CSF through lumbar puncture

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

    Time frame: 18 months

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

Secondary outcomes

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

    Time frame: 18 months

    MRI findings of the lesion, Nerve conduction studies of the region and somatosensory evoked potentials of the same region

Sponsors and collaborators

Lead sponsor

International Stemcell Services Limited

Industry

Registry information

Official study 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

Acronym: ABMST-SCI

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 23, 2010
Registry last updated
Aug 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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