CLBS201 in Patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM)

A Phase 1 Open-Label, Proof-of-Concept Study to Evaluate the Safety and Efficacy of CLBS201 Autologous Peripheral Blood-Derived CD34+ Cells in Subjects with Chronic Kidney Disease and Type 2 Diabetes Mellitus

CLBS201 will evaluate the safety, tolerability, and therapeutic effect in subjects with CKD and T2DM.

Inclusion Criteria:

1. Adults aged 18 to 75 years, inclusive
2. Documented diagnosis of type 2 diabetes
3. eGFR of 30 to <45 mL/min/1.73m at the screening visit.
4. UACR 300 mg/g to ≤ 5000 mg/g

Exclusion Criteria:

1. Hemoglobin < 10 g/dL
2. Hemoglobin A1c ≥8% at the time of screening
3. Acute kidney injury within 6 months prior to screening