REGEN-006
Research type
Research Study
Full title
A PHASE 3 RANDOMIZED CONTROLLED STUDY OF RENAL AUTOLOGOUS CELL THERAPY (REACT) IN SUBJECTS WITH TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE (REGEN-006)
IRAS ID
1004289
Contact name
Kieran McCafferty
Contact email
Sponsor organisation
ProKidney
Eudract number
2020-004293-21
Clinicaltrials.gov Identifier
Research summary
ProKidney is conducting a clinical research study of a not yet approved treatment called Renal Autologous Cell Therapy (REACT) in participants with type 2 diabetes and chronic kidney disease (CKD). The kidneys’ main function is to get rid of waste products (for example, urine). Kidney disease can lead to kidney function weakening or failure (ending). Chronic kidney failure means that the kidneys' ability to purify (clean) the blood and regulate water in the body is impaired. Chronic kidney failure develops gradually, and the disease is incurable at late stages. The main purpose of this study is to see whether REACT is safe and works to improve or stabilise kidney function when given as 2 injections approximately 3 months apart into the kidneys. To ensure the data is sufficient, the study is placebo controlled and blinded for the participant. One Cohort won't have the procedures performed like biopsies or reinjection, but minor incisions will be made and locally sedated, to ensure the participant doesn't know if he will receive REACT or Placebo. REACT will be made by using each patients own kidney cells. Kidney cells will be taken during a procedure called a ‘biopsy’ where an small amount of tissue is taken from the participants kidney with a small needle. The cells taken during the biopsy will be used to make the REACT product, which will then after preparation by the sponsor be reinjected in the kidney of the participant. this will happen twice 3 month apart and the participant will be 34 months in total in this study as a long term FU is planned to evaluate how well, good and safe REACT works.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0381
Date of REC Opinion
4 Aug 2022
REC opinion
Further Information Favourable Opinion