Chronic Kidney DiseasesPhase 1NCT04990427
CLBS201 in Patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM)
A Phase 1 study testing CLBS201 in people with Chronic Kidney Diseases, run by Lisata Therapeutics, Inc. at 1 site in United States.
Trial summary
CLBS201 will evaluate the safety, tolerability, and therapeutic effect in subjects with CKD and T2DM. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- CLBS201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2022to 26 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hemoglobin < 10 g/dL
- Hemoglobin A1c ≥8% at the time of screening
- Acute kidney injury within 6 months prior to screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Advancement Center, PLLC
San Antonio, Texas, 78212
About this study
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
CLBS201 will evaluate the safety, tolerability, and therapeutic effect in subjects with CKD and T2DM.
- Conditions
- Chronic Kidney Diseases
- Being tested
- CLBS201
- Keywords
- Chronic Kidney disease, Type 2 Diabetes Mellitus, Diabetic Kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLBS201Drug
1 x 10^6 to 300 x 10^6 autologous CD34+ cells
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CLBS201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
Proportion of patients with a treatment-emergent serious adverse event
Measured: 6 Months
Secondary outcomes (2)
Estimated Glomerular Filtration Rate (eGFR)
Change in eGFR from baseline
Measured: 6 Months
UACR & UPCR
Change in UACR \& UPCR from baseline
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start10 Jan 2022
- Primary completion26 Jan 2023
- Study completion26 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisata Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristen K Buck, MD, Study director, Lisata Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990427
- Sponsor's protocol ID
- CLBS201-P01a
- Status last verified
- Oct 2024
- First submitted
- 30 Jul 2021
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04990427
- Acronym / sponsor ID
- CLBS201-P01a
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic Kidney disease, Type 2 Diabetes Mellitus, Diabetic Kidney disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Lisata Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CLBS201 will evaluate the safety, tolerability, and therapeutic effect in subjects with CKD and T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLBS201 | Experimental | Drug: CLBS201CLBS201 will be administered in an open-label fashion via intra-renal-arterial infusion in 6 subjects followed by 6 months of observation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Hemoglobin < 10 g/dL
- Hemoglobin A1c ≥8% at the time of screening
- Acute kidney injury within 6 months prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLBS2011 x 10^6 to 300 x 10^6 autologous CD34+ cells | Drug | CLBS201 |
Primary outcome
Serious Adverse Events
Time frame: 6 Months
Proportion of patients with a treatment-emergent serious adverse event
2 secondary outcomes
Estimated Glomerular Filtration Rate (eGFR)
Time frame: 6 Months
UACR & UPCR
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen K Buck, MD study director
Lisata Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CLBS201 in people with Chronic Kidney Diseases, run by Lisata Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.