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Transplantation of Autologous Bone Marrow or Leukapheresis-Derived Stem Cells for Treatment of Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02687672
Recruitment Status : Unknown
Verified March 2020 by Stem Cells Arabia.
Recruitment status was:  Recruiting
First Posted : February 22, 2016
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Stem Cells Arabia

Study Description
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Brief Summary:
This is a double-armed, Phase I/II trial aims to compare bone marrow and leukapheresis as sources for purified, autologous CD34+ and CD133+ stem cells (SCs), to be utilized in treatment of patients with chronic complete spinal cord injuries (SCI). The study focuses on the safety and efficacy of transplanting un-manipulated, autologous, purified stem cells into the injured spinal cords of patients.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Biological: Stem Cell Transplantation Phase 2

Detailed Description:
Spinal cord injury (SCI) leads to apoptosis of oligodendrocytes at the injury site resulting in demyelination and neuronal degeneration. This degeneration causes severe functional sensory and motor mutilations that remain an immense challenge to physicians and in which stem cell (SC) transplantation represents a viable alternative. This study is a phase I/II trial aimed at describing a method for treating patients with chronic complete spinal cord injuries (SCI) by utilizing autologous, purified CD34+ and CD133+ stem cells (SCs). The study focuses on the safety and efficacy of transplanting un-manipulated, autologous, purified stem cells in treated patients during a 5-year follow-up period.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transplantation of Purified Autologous Bone Marrow- or Leukapheresis-Derived CD34+ and CD133+ for Patients With Spinal Cord Injuries: A Long-Term Comparative Evaluation of Safety and Efficacy Study.
Study Start Date : January 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Stem Cell Transplantation
Injection of leukapheresis-derived, purified, autologous CD34+and CD133+ stem cells
 Biological: Stem Cell Transplantation
Transplantation of autologous stem cells
Experimental: Stem Cells
Injection of bone marrow-derived, purified, autologous CD34+and CD133+ stem cells.
 Biological: Stem Cell Transplantation
Transplantation of autologous stem cells


Outcome Measures
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Primary Outcome Measures :
  1. Overall clinical improvement in sensory and motor functions using ASIA (American Spinal Cord Injury Association) [ Time Frame: 60 months ]

Secondary Outcome Measures :
  1. Improvement in urine and stool incontinence using a questionnaire [ Time Frame: 6 months ]
  2. Functional improvement in impotence and previous sexual erection status (male patients) using a questionnaire [ Time Frame: 6 months ]
  3. Improvement in quality of life using a questionnaire [ Time Frame: 6 months ]
  4. Improvement in personal independence and productivity using questionnaire [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suffering from chronic spinal cord injury
  • Age of injury ranging from 6-60 months prior to enrollment in this study.
  • Ability and willingness to regularly visit Jordan Orthopedic and Spinal Center for post operation follow up.
  • Traumatic Injury of spinal cord with complete or partial damage confirmed by MRI.

Exclusion Criteria:

  • Injuries less than 6 months old or more than 60 months old
  • Non-traumatic injuries (SCI due to inflammation, autoimmune diseases)
  • Patients less than 5 or older than 50 years
  • Patients suffering from other conditions, including chronic neurological diseases, diabetes mellitus, cardiac/kidney/liver disorders, previous strokes, and previous surgeries unrelated to spinal cord injury.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687672


Contacts
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Contact: Adeeb AlZoubi, PhD 00962795337575 adeebalzoubi@stemcellsarabia.net

Locations
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Jordan
Stem Cells Arabia Recruiting
Amman, Jordan, 11953
Contact: Adeeb AlZoubi, PhD    00962795337575    adeebalzoubi@stemcellsarabia.net   
Sponsors and Collaborators
Stem Cells Arabia
More Information
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Responsible Party: Stem Cells Arabia
ClinicalTrials.gov Identifier: NCT02687672    
Other Study ID Numbers: SCA-SCI1
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System