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Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for OA

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: NCT05147675
Recruitment Status : Recruiting
First Posted : December 7, 2021
Last Update Posted : December 7, 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 cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously and intraarticularly for the treatment of Osteoarthritis.

Condition or disease Intervention/treatment Phase
Osteoarthritis Spinal Arthritis Biological: AlloRx Phase 1

Detailed Description:
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Osteoarthritis (OA). This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of OA. Patients with OA will receive intravenous infusion and intraarticular injection of UC-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 : 20 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 Cells for the Treatment of Osteoarthritis
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 (AlloRx)
Intravenous infusion and intraarticular injection (total dose 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: Single Assessment Numeric Evaluation Score (SANE) [ Time Frame: Four year follow-up ]
    ranging from 0 to 100%



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 Osteoarthritis
  • 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): NCT05147675


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: NCT05147675    
Other Study ID Numbers: ATG-1-MSC-011
First Posted: December 7, 2021    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: November 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:
Osteoarthritis
stem cell treatment
Spinal Arthritis
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Osteoarthritis
Spondylarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spinal Diseases
Bone Diseases
Bone Diseases, Infectious
Infections