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Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Intrathecal Injection for SCI

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: NCT05018793
Recruitment Status : Suspended (Covid-19)
First Posted : August 24, 2021
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
The Foundation for Orthopaedics and Regenerative Medicine

Brief Summary:
This trial will study the safety and efficacy of intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells for the treatment of spinal cord injury

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Biological: autologous adipose derived mesenchymal stem cells Phase 1

Detailed Description:
Studies have shown that stem cell treatment is safe and efficacious for the treatment of spinal cord injury (SCI). This patient funded trial aims to study the safety and efficacy of intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells (AD-MSCs) for the treatment of SCI. Patients with SCI will receive a single intrathecal injection of AD-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Spinal Cord Injury
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
Single intrathecal injection of 100 million cells
Biological: autologous adipose derived mesenchymal stem cells
cultured autologous adult adipose derived mesenchymal stem cells




Primary Outcome Measures :
  1. Safety (adverse events) [ Time Frame: Four year follow-up ]
    Clinical monitoring of possible adverse events or complications


Secondary Outcome Measures :
  1. Efficacy: American Spinal Injury Association Impairment Scale (ASIA) [ Time Frame: Four year follow-up ]
    It will be completed for each follow up point



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Spinal Cord Injury
  • Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

  • Active infection
  • Active cancer
  • Chronic multisystem organ failure
  • Pregnancy
  • Anticoagulation medicine use
  • Clinically significant Abnormalities on pre-treatment laboratory evaluation
  • Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
  • Previous organ transplant
  • Hypersensitivity to sulfur
  • Continued drug abuse
  • Pre-menopausal women not using contraception

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): NCT05018793


Locations
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Greece
Mitera Hospital Athens Greece
Marousi, Greece
Sponsors and Collaborators
The Foundation for Orthopaedics and Regenerative Medicine
Investigators
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Principal Investigator: Chadwick Prodromos, MD The Foundation for Orthopaedics and Regenerative Medicine
Publications:
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Responsible Party: The Foundation for Orthopaedics and Regenerative Medicine
ClinicalTrials.gov Identifier: NCT05018793    
Other Study ID Numbers: SC-8-GR-10-02
First Posted: August 24, 2021    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: August 2021

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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.: Yes
Keywords provided by The Foundation for Orthopaedics and Regenerative Medicine:
spinal cord injury
SCI
stem cell treatment
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