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Completed

NCT Number: NCT00816803

Cell Transplant in Spinal Cord Injury Patients

This study is designed to assess the safety of autologous bone marrow derived cell transplant in chronic spinal cord injury patients. The hypothesis is that the availability of bone marrow derived mesenchymal stem cells at the sites of injury promote neuronal regeneration.

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Key information

Conditions

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

Age range

10 year–36 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cairo University School of Medicine

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Traumatic spinal cord injury
  • No concomitant systemic disease
  • No progress on physiotherapy for at least 6 months
  • Duration of injury from 10 months to 3 years

Exclusion criteria

  • Non-traumatic spinal cord injury whether transverse myelitis or demyelination
  • Concomitant systemic disease
  • Progress can be observed on physiotherapy
  • Acute injury or duration of injury less than 10 months

Treatment and study plan

Autologous bone marrow transplant

Procedure

physical therapy

Procedure

Primary outcomes

  1. Safety of autologous BM transplant measured by absence of neuronal changes, infections or increased intracranial tension, and monitoring for any abnormal growth or tumor formation by MRI.

    Time frame: 18 months

Secondary outcomes

  1. Efficacy of BM cell transplant in improving neurological functions in patients with chronic SCI. Improvement in motor, sensory and sphincteric functions, and quality of life using ASIA scores and MRI.

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Al-Azhar University
  • Alexandria University
  • Medical Military Academy, Egypt

Registry information

Official study title

Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jan 5, 2009
Registry last updated
Jan 5, 2009

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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