Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product

Prokidney

Status: Invitation-only

Conditions: Chronic Kidney Disease; Diabetic Kidney Disease

Treatments: Biological: Renal Autologous Cell Therapy (REACT)

Study type: Observational

Funder types: Industry

Identifiers

NCT06790498

REGEN-008S2

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety, efficacy, and durability in participants with chronic kidney disease (CKD) who received up to four REACT injections, delivered percutaneously into either the same or bilateral kidneys in previous studies.

Full description

This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 50 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (REGEN-007, REGEN-006, REGEN-015) will be monitored for up to five years with alternating in clinic and phone visits.

Enrollment: 50 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The participant must have received REACT in a previous trial (REGEN-006, REGEN- 007, and REGEN-015) for the treatment of chronic kidney disease and completed an end of study visit in their previous trial per protocol.
• The participant is willing and able to cooperate with all aspects of the protocol.
• The participant is willing and able to provide signed informed consent.

Exclusion criteria

• Participant did not receive REACT in a previous trial for the treatment of chronic kidney disease

Trial design

50 participants in 1 patient group

CKD patients previously treated with REACT

Description:

Participants Exposed to Renal Autologous Cell Therapy from studies REGEN-007, REGEN-006, REGEN-015 (REGEN-008S2).

Treatment:

Biological: Renal Autologous Cell Therapy (REACT)