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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04990427

Enrollment

Registered

2021-08-04

Start date

2022-01-10

Completion date

2023-01-26

Last updated

2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney disease, Type 2 Diabetes Mellitus, Diabetic Kidney disease

Brief summary

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

Interventions

DRUGCLBS201

1 x 10\^6 to 300 x 10\^6 autologous CD34+ cells

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Serious Adverse Events	6 Months	Proportion of patients with a treatment-emergent serious adverse event

Secondary

Measure	Time frame	Description
Estimated Glomerular Filtration Rate (eGFR)	6 Months	Change in eGFR from baseline
UACR & UPCR	6 Months	Change in UACR & UPCR from baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026