Diabetic Kidney Disease Cell Therapy Trial Completes Enrollment


Topline results are expected in the first quarter of 2023.

Caladrius BIosciences has completed enrollment of its phase 1b clinical trial (NCT04990427) of CLBS201, an investigative cell therapy for the treatment of diabetic kidney disease (DKD).1

“We are pleased to announce that we have treated the last subject in our Phase 1b clinical trial evaluating CLBS201, which focuses on individuals who exhibit rapidly progressing stage 3b/4 DKD,” Kristen K. Buck, MD, executive vice president, research and development, and chief medical officer, Caladrius, said in a statement.1 “We look forward to sharing top-line data after all subjects have completed their six-month follow-up visit.”

The phase 1b trial is an open-label, proof-of-concept study of CLBS201. The study has enrolled 6 participants in the pre-dialysis stage of kidney disease with rapidly progressing stage 3b disease. The study is primarily assessing safety as measured by the incidence of adverse events (AEs). Secondary outcome measures include the change in estimated glomerular filtration rate at 6 months from baseline and the change in albumin/creatinine and protein/creatinine ratios at 6 months from baseline. Top-line data from all participants are expected by the first quarter of 2023.

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CLBS201 is a CD34+ regenerative cell therapy candidate delivered via intra-renal artery administration in patients with DKD. The therapy has previously demonstrated protection or replenishment of microcirculation in the kidney in preclinical studies in kidney disease and injury models, making it a promising treatment option for DKD, in which progressive kidney failure is associated with attrition of the microcirculation.

"Intra-renal artery infusion of CD34+ cells could be a breakthrough in the treatment of diabetic kidney disease; we are excited about our work with Caladrius on this program,” principal investigator Pablo Pergola, MD, PhD, Research Director, Renal Associates, P.A., San Antonio, Texas, added to the statement.1 “We look forward to reviewing the results of this study and the potential development of a treatment for patients in need.”

The enrollment completion builds off of the Independent Data Monitoring Committees positive recommendation for the trial to continue without modification in May 2022.2 At this time, no safety or tolerability concerns had been observed in the first 2 patients treated and monitored.

“We are very pleased with the progress of the study and with the recommendations of the IDMC,” Buck said in a previous statement.2 “We find it encouraging that CLBS201 appeared to be well-tolerated based on the initial assessment of data. We look forward to continuing this study and hope to rapidly enroll the remaining patients, leading to top-line data by the first quarter of 2023.”

1. Caladrius Biosciences completes enrollment in phase 1b study of CLBS201 for the treatment of diabetic kidney disease. News release. Caladrius Biosciences. August 2, 2022. https://www.globenewswire.com/news-release/2022/08/02/2490298/18623/en/Caladrius-Biosciences-Completes-Enrollment-in-Phase-1b-Study-of-CLBS201-for-the-Treatment-of-Diabetic-Kidney-Disease.html
2. Caladrius Biosciences announces IDMC recommendation to advance CLBS201 trial for the treatment of diabetic kidney disease. News release. Caladrius Biosciences. May 19, 2022. https://ir.caladrius.com/news-releases/news-release-details/caladrius-biosciences-announces-idmc-recommendation-advance
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