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NCT04990427 | COMPLETED | Chronic Kidney Diseases

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

Lisata Therapeutics, Inc.

Brief Summary:

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

Condition or disease

Chronic Kidney Diseases

Intervention/treatment

CLBS201

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 6 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2022-01-10
Estimated Primary Completion Date : 2023-01-26
Estimated Study Completion Date : 2023-01-26

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
CLBS201 in Patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM)

Location Details

NCT04990427

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Texas

Clinical Advancement Center, PLLC

San Antonio, Texas, United States, 78212