NCT04990427

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2023

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

July 30, 2021

Last Update Submit

October 7, 2024

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney diseaseType 2 Diabetes MellitusDiabetic Kidney disease

Outcome Measures

Primary Outcomes (1)

  • Serious Adverse Events

    Proportion of patients with a treatment-emergent serious adverse event

    6 Months

Secondary Outcomes (2)

  • Estimated Glomerular Filtration Rate (eGFR)

    6 Months

  • UACR & UPCR

    6 Months

Study Arms (1)

CLBS201

EXPERIMENTAL

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

Interventions

CLBS201DRUG

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

CLBS201

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Advancement Center, PLLC

San Antonio, Texas, 78212, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicDiabetes Mellitus, Type 2Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetes Complications

Study Officials

  • Kristen K Buck, MD

    Lisata Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2021

First Posted

August 4, 2021

Study Start

January 10, 2022

Primary Completion

January 26, 2023

Study Completion

January 26, 2023

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)