Back to resultsCLBS201 in Patients With Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM)
Primary Purpose
Chronic Kidney Diseases
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CLBS201
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Chronic Kidney disease, Type 2 Diabetes Mellitus, Diabetic Kidney disease
Eligibility Criteria
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
Sites / Locations
- Clinical Advancement Center, PLLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CLBS201
Arm Description
CLBS201 will be administered in an open-label fashion via intra-renal-arterial infusion in 6 subjects followed by 6 months of observation.
Outcomes
Primary Outcome Measures
Serious Adverse Events
Proportion of patients with a treatment-emergent serious adverse event
Secondary Outcome Measures
Estimated Glomerular Filtration Rate (eGFR)
Change in eGFR from baseline
UACR & UPCR
Change in UACR & UPCR from baseline
Full Information
NCT ID
NCT04990427
First Posted
July 30, 2021
Last Updated
April 17, 2023
Sponsor
Lisata Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04990427
Brief Title
CLBS201 in Patients With Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
January 26, 2023 (Actual)
Study Completion Date
January 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lisata Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
CLBS201 will evaluate the safety, tolerability, and therapeutic effect in subjects with CKD and T2DM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Chronic Kidney disease, Type 2 Diabetes Mellitus, Diabetic Kidney disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLBS201
Arm Type
Experimental
Arm Description
CLBS201 will be administered in an open-label fashion via intra-renal-arterial infusion in 6 subjects followed by 6 months of observation.
Intervention Type
Drug
Intervention Name(s)
CLBS201
Intervention Description
1 x 10^6 to 300 x 10^6 autologous CD34+ cells
Primary Outcome Measure Information:
Title
Serious Adverse Events
Description
Proportion of patients with a treatment-emergent serious adverse event
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Estimated Glomerular Filtration Rate (eGFR)
Description
Change in eGFR from baseline
Time Frame
6 Months
Title
UACR & UPCR
Description
Change in UACR & UPCR from baseline
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen K Buck, MD
Organizational Affiliation
Lisata Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CLBS201 in Patients With Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM)
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