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

Phase 1
Completed
Conditions
Chronic Kidney Diseases
Interventions
Drug: CLBS201
Registration Number
NCT04990427
Lead Sponsor
Lisata Therapeutics, Inc.
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
6
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
CLBS201CLBS201CLBS201 will be administered in an open-label fashion via intra-renal-arterial infusion in 6 subjects followed by 6 months of observation.
Primary Outcome Measures
NameTimeMethod
Serious Adverse Events6 Months

Proportion of patients with a treatment-emergent serious adverse event

Secondary Outcome Measures
NameTimeMethod
Estimated Glomerular Filtration Rate (eGFR)6 Months

Change in eGFR from baseline

UACR & UPCR6 Months

Change in UACR \& UPCR from baseline

Trial Locations

Locations (1)

Clinical Advancement Center, PLLC

🇺🇸

San Antonio, Texas, United States

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