A Long-Term Follow-Up Study of Participants Exposed to REACT

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety of up to two gelatin-hydrogel formulation REACT injections given 3 to 6 months apart and delivered percutaneously into same kidney on renal function in participants with chronic kidney disease (CKD).

Detailed Description
-----------------
This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 80 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (RMCL-002, REGEN-003, REGEN-004) will be monitored for up to five years with alternating in clinic and phone visits.

Official Title
-----------------
A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies RMCL-002, REGEN-003, REGEN-004

Conditions
-----------------
Diabetic Kidney Disease, Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Biological: Renal Autologous Cell Therapy (REACT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant must have received gelatin-hydrogel formulation REACT in a previous trial (RMCL-002, REGEN-003, REGEN-004) for the treatment of chronic kidney disease and completed an end of study visit in their parent trial per protocol. Exclusion Criteria: The participant did not receive REACT in a previous trial for the treatment of chronic kidney disease.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CKD patients previously treated with REACT<br>Participants Exposed to Renal Autologous Cell Therapy from studies RMCL-002, REGEN-003, REGEN-004 (REGEN-008S1). | Biological: Renal Autologous Cell Therapy (REACT)<br>* No interventions in this trial<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint: Long-term safety of REACT | Evaluation of the long-term safety of REACT will be assessed via: Incidence of delayed serious adverse events (SAEs) obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. Incidence of delayed biopsy-related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. Incidence of delayed injection procedure related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. Incidence of delayed investigational product related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. | 60 months from completion of parent protocol EOS Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Secondary Endpoint: Time from first injection to eGFR <15 mL/min/1.73m² | Time from first injection to eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation. | 60 months from completion of parent protocol EOS Visit | 
| Second Secondary Endpoint: Time from first injection to chronic dialysis. | Time from first injection to chronic dialysis. | 60 months from completion of parent protocol EOS Visit | 
| Third Secondary Endpoint: Time from first injection to renal transplant. | Time from first injection to renal transplant. | 60 months from completion of parent protocol EOS Visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DKD, REACT, CKD