Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for CKD
Primary Purpose
Chronic Kidney Diseases
Status
Recruiting
Phase
Phase 1
Locations
Antigua and Barbuda
Study Type
Interventional
Intervention
AlloRx
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Renal Failure, stem cell treatment, Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Chronic Kidney Disease
- 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
Sites / Locations
- Medical Surgical Associates CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group (AlloRx)
Arm Description
Single intravenous infusion of 100 million cells
Outcomes
Primary Outcome Measures
Safety (adverse events)
Clinical monitoring of possible adverse events or complications
Secondary Outcome Measures
Efficacy: creatinine levels
It will be completed for each follow up point.
Efficacy: changes in eGFR
It will be completed for each follow up point.
Full Information
NCT ID
NCT05018845
First Posted
August 20, 2021
Last Updated
October 25, 2022
Sponsor
The Foundation for Orthopaedics and Regenerative Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05018845
Brief Title
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for CKD
Official Title
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Chronic Kidney Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2021 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Foundation for Orthopaedics and Regenerative Medicine
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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 Chronic Kidney Disease.
Detailed Description
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Chronic Kidney Disease (CKD). This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of CKD. Patients with CKD will receive a single intravenous infusion 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.
For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Renal Failure, stem cell treatment, Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group (AlloRx)
Arm Type
Experimental
Arm Description
Single intravenous infusion of 100 million cells
Intervention Type
Biological
Intervention Name(s)
AlloRx
Intervention Description
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Primary Outcome Measure Information:
Title
Safety (adverse events)
Description
Clinical monitoring of possible adverse events or complications
Time Frame
Four year follow-up
Secondary Outcome Measure Information:
Title
Efficacy: creatinine levels
Description
It will be completed for each follow up point.
Time Frame
Four year follow-up
Title
Efficacy: changes in eGFR
Description
It will be completed for each follow up point.
Time Frame
Four year follow-up
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Chronic Kidney Disease
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chadwick Prodromos, MD
Organizational Affiliation
The Foundation for Orthopaedics and Regenerative Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Surgical Associates Center
City
St. John's
Country
Antigua and Barbuda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chadwick Prodromos, M.D.
Phone
8476996810
Email
care@thepsci.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
24135082
Citation
Belingheri M, Lazzari L, Parazzi V, Groppali E, Biagi E, Gaipa G, Giordano R, Rastaldi MP, Croci D, Biondi A, Rebulla P, Edefonti A, Ghio L. Allogeneic mesenchymal stem cell infusion for the stabilization of focal segmental glomerulosclerosis. Biologicals. 2013 Nov;41(6):439-45. doi: 10.1016/j.biologicals.2013.09.004. Epub 2013 Oct 14.
Results Reference
background
PubMed Identifier
29187247
Citation
Rahyussalim AJ, Saleh I, Kurniawati T, Lutfi APWY. Improvement of renal function after human umbilical cord mesenchymal stem cell treatment on chronic renal failure and thoracic spinal cord entrapment: a case report. J Med Case Rep. 2017 Nov 30;11(1):334. doi: 10.1186/s13256-017-1489-7. Erratum In: J Med Case Rep. 2023 May 9;17(1):207.
Results Reference
background
Learn more about this trial
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for CKD
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