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OpenTrials
Completed

NCT Number: NCT04990427

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

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

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Nephropathies Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Advancement Center, PLLC

San Antonio, Texas, 78212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 to 75 years, inclusive
  • Documented diagnosis of type 2 diabetes
  • eGFR of 30 to <45 mL/min/1.73m at the screening visit.
  • UACR 300 mg/g to ≤ 5000 mg/g

Exclusion criteria

  • Hemoglobin < 10 g/dL
  • Hemoglobin A1c ≥8% at the time of screening
  • Acute kidney injury within 6 months prior to screening

Treatment and study plan

CLBS201

Drug

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

Primary outcomes

  1. Serious Adverse Events

    Time frame: 6 Months

    Proportion of patients with a treatment-emergent serious adverse event

Secondary outcomes

  1. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: 6 Months

    Change in eGFR from baseline

  2. UACR & UPCR

    Time frame: 6 Months

    Change in UACR & UPCR from baseline

Sponsors and collaborators

Lead sponsor

Lisata Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 4, 2021
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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