CLBS201 in Patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM)
NCT ID: NCT04990427
Last Updated: 2024-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2022-01-10
2023-01-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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CLBS201
CLBS201 will be administered in an open-label fashion via intra-renal-arterial infusion in 6 subjects followed by 6 months of observation.
CLBS201
1 x 10\^6 to 300 x 10\^6 autologous CD34+ cells
Interventions
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CLBS201
1 x 10\^6 to 300 x 10\^6 autologous CD34+ cells
Eligibility Criteria
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Inclusion Criteria
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
2. Hemoglobin A1c ≥8% at the time of screening
3. Acute kidney injury within 6 months prior to screening
18 Years
75 Years
ALL
No
Sponsors
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Lisata Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kristen K Buck, MD
Role: STUDY_DIRECTOR
Lisata Therapeutics, Inc.
Locations
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Clinical Advancement Center, PLLC
San Antonio, Texas, United States
Countries
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Other Identifiers
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CLBS201-P01a
Identifier Type: -
Identifier Source: org_study_id
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