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

Chronic Kidney Diseases Clinical Trial

Official title:

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Chronic Kidney Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05018845
• Other study ID #: SC-20-ATG-22
• Status: Recruiting
• Phase: Phase 1
• Start date: November 6, 2021
• Est. completion date: November 2025

Study information

• Verified date: October 2022
• Source: The Foundation for Orthopaedics and Regenerative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Biological:
• AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Locations

Country	Name	City	State
Antigua and Barbuda	Medical Surgical Associates Center	St. John's

Sponsors (1)

Lead Sponsor	Collaborator
The Foundation for Orthopaedics and Regenerative Medicine

Country where clinical trial is conducted

Antigua and Barbuda, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (adverse events)	Clinical monitoring of possible adverse events or complications	Four year follow-up
Secondary	Efficacy: creatinine levels	It will be completed for each follow up point.	Four year follow-up
Secondary	Efficacy: changes in eGFR	It will be completed for each follow up point.	Four year follow-up