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NCT04990427 Clinical Trial

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

Chronic Kidney Diseases Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04990427
Other study ID # CLBS201-P01a
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 10, 2022
Est. completion date January 26, 2023

Study information
Verified date April 2023
Source Lisata Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date January 26, 2023
Est. primary completion date January 26, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CLBS201
1 x 10^6 to 300 x 10^6 autologous CD34+ cells

Locations
Country Name City State
United States Clinical Advancement Center, PLLC San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Lisata Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serious Adverse Events Proportion of patients with a treatment-emergent serious adverse event 6 Months
Secondary Estimated Glomerular Filtration Rate (eGFR) Change in eGFR from baseline 6 Months
Secondary UACR & UPCR Change in UACR & UPCR from baseline 6 Months
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