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Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IBD

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05003947
Recruitment Status : Recruiting
First Posted : August 13, 2021
Last Update Posted : August 13, 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 intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of inflammatory bowel disease

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Biological: AlloRx Phase 1

Detailed Description:
Studies have shown that stem cell treatment is safe and efficacious for the treatment of inflammatory bowel disease (IBD). Patients with IBD will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. 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 Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Inflammatory Bowel Disease
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Arm Intervention/treatment
Experimental: Treatment Group
Single intravenous infusion of 100 million cells
Biological: AlloRx
cultured allogeneic adult umbilical cord 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: The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) [ Time Frame: Four year follow-up ]
    The SIBDQ is a questionnaire to assess the physical, social, emotional, and systemic status for IBD patients. It will be completed for each follow up point.



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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 Crohn's disease or Ulcerative Colitis
  • Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

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

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): NCT05003947


Locations
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Antigua and Barbuda
Medical Surgical Associates Center Recruiting
St. John's, Antigua and Barbuda
Contact: Chadwick Prodromos, M.D.    8476996810    research@ismoc.net   
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: NCT05003947    
Other Study ID Numbers: SC-8-ATG-11-04
First Posted: August 13, 2021    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
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:
IBD
Inflammatory Bowel Diseases
stem cell treatment
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis