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

Lisata Therapeutics

Status and phase: Completed; Phase 1

Conditions: Chronic Kidney Diseases

Treatments: Drug: CLBS201

Study type: Interventional

Funder types: Industry

Identifiers

NCT04990427

CLBS201-P01a

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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6 participants in 1 patient group

CLBS201

Experimental group

Description:

CLBS201 will be administered in an open-label fashion via intra-renal-arterial infusion in 6 subjects followed by 6 months of observation.

Treatment:

Drug: CLBS201