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

Phase 1CompletedNCT04990427

Lisata Therapeutics, Inc.6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Kidney Diseases

Interventions

CLBS201DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinical Advancement Center, PLLC

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Serious Adverse Events

Proportion of patients with a treatment-emergent serious adverse event

Time frame: 6 Months

Secondary Outcomes

Estimated Glomerular Filtration Rate (eGFR)

Change in eGFR from baseline

Time frame: 6 Months

UACR & UPCR

Change in UACR \& UPCR from baseline

Time frame: 6 Months

Data from ClinicalTrials.gov

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