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

Sponsor

Caladrius Biosciences, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04990427

Collaborator

(none)

Enrollment

Location

Arm

13.4

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases	Drug: CLBS201	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

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 :

Dec 17, 2021

Anticipated Primary Completion Date :

Jan 28, 2023

Anticipated Study Completion Date :

Jan 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CLBS201 CLBS201 will be administered in an open-label fashion via intra-renal-arterial infusion in 6 subjects followed by 6 months of observation.	Drug: CLBS201 1 x 10^6 to 300 x 10^6 autologous CD34+ cells

Arm

Intervention/Treatment

Experimental: CLBS201

CLBS201 will be administered in an open-label fashion via intra-renal-arterial infusion in 6 subjects followed by 6 months of observation.

Drug: CLBS201

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

Outcome Measures

Primary Outcome Measures

Serious Adverse Events [6 Months]
Proportion of patients with a treatment-emergent serious adverse event

Secondary Outcome Measures

Estimated Glomerular Filtration Rate (eGFR) [6 Months]
Change in eGFR from baseline
UACR & UPCR [6 Months]
Change in UACR & UPCR from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Advancement Center, PLLC	San Antonio	Texas	United States	78212

Sponsors and Collaborators

Caladrius Biosciences, Inc.

Investigators

Study Director: Kristen K Buck, MD, Executive Vice President R&D and Chief Medical Officer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Caladrius Biosciences, Inc.

ClinicalTrials.gov Identifier:

NCT04990427

Other Study ID Numbers:

CLBS201-P01a

First Posted:

Aug 4, 2021

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Caladrius Biosciences, Inc.

Chronic Kidney disease

Type 2 Diabetes Mellitus

Diabetic Kidney disease

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 4, 2022