Coronary Microvascular DysfunctionPhase 2NCT03508609
Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
A Phase 2 study testing CLBS16 in people with Coronary Microvascular Dysfunction, run by Lisata Therapeutics, Inc. at 2 sites in United States.
Trial summary
This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo selected CD34 cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single intracoronary infusion of CLBS16. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Microvascular Dysfunction
- What is being tested?
- CLBS16
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Apr 2018to 5 May 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women age ≥18
- History of and currently experiencing angina at least 3 times per week
- No obstructive coronary artery disease
- On stable medical therapy for 30 days prior to enrollment
- Must agree to use a reliable and acceptable method of contraception for the duration of participation
- Written informed consent
Who cannot join
- Myocardial infarction within 90 days
- Prior evidence of obstructive heart disease including PCI or CABG (or planned PCI or CABG)
- Diagnosis of other specific cardiac disease
- Must meet LVEF and GFR requirements
- Current use of coumadin or DOACs
- Hypersensitivity to G-CSF, apheresis or study product components
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- Positive for HIV, hepatitis B or hepatitis C
- Active inflammatory or autoimmune disease, or chronic immunosuppressive state
- Drug abuse
- Pregnant or lactating
- Malignant neoplasm within 5 years
- History of Sickle Cell Disease
- Participation in another clinical study within 90 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: An Open-Label Exploratory Clinical Study to Evaluate the Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction (CMD) and Without Obstructive Coronary Artery Disease
This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo selected CD34 cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single intracoronary infusion of CLBS16.
- Conditions
- Coronary Microvascular Dysfunction
- Being tested
- CLBS16
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLBS16Biological
GCSF-mobilized autologous CD34 cells
| Study group | Role | What they receive |
|---|---|---|
| Autologous CD34 cells | Experimental | Open label active treatment arm. Subjects receive autologous CD34 cells. Receives: Biological: CLBS16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Coronary Flow Reserve
Coronary Flow Reserve (CFR) is a measure of coronary microvascular function.
Measured: Day 180
Secondary outcomes (6)
Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine
Measured: Day 180
Change From Baseline in Peripheral Arterial Tonometry
Measured: Day 180
Change in Angina Frequency From Baseline
Measured: 6 months
Canadian Cardiovascular Society Angina Class
Canadian Cardiovascular Society angina class grading scale is assessed according to the following scores:
Grade 1: Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina with strenuous or rapid or prolonged exertion at work or recreation Grade 2: Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions Grade 3: Marked limitation of ordinary physical activity. Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace Grade 4: Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest A higher grade is a worse outcome.
Measured: 6 months
Change From Baseline in Seattle Angina Questionnaire
The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
Measured: 6 months
Change From Baseline in SF-36 Scores
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
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 posted26 Apr 2018
- Study start19 Apr 2018
- Primary completion10 Dec 2019
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Microvascular DysfunctionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisata Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Cedars-Sinai Medical Center, Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Douglas W. Losordo, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508609
- Sponsor's protocol ID
- CLBS16-P01
- Other IDs
- 1R44HL135889-01
- Status last verified
- Nov 2020
- First submitted
- 16 Apr 2018
- Last updated
- 8 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Henry TD, Bairey Merz CN, Wei J, Corban MT, Quesada O, Joung S, Kotynski CL, Wang J, Lewis M, Schumacher AM, Bartel RL, Takagi H, Shah V, Lee A, Sietsema WK, Losordo DW, Lerman A. Autologous CD34+ Stem Cell Therapy Increases Coronary Flow Reserve and Reduces Angina in Patients With Coronary Microvascular Dysfunction. Circ Cardiovasc Interv. 2022 Feb;15(2):e010802. doi: 10.1161/CIRCINTERVENTIONS.121.010802. Epub 2022 Jan 23.
PubMed 35067072Rai B, Shukla J, Henry TD, Quesada O. Angiogenic CD34 Stem Cell Therapy in Coronary Microvascular Repair-A Systematic Review. Cells. 2021 May 8;10(5):1137. doi: 10.3390/cells10051137.
PubMed 34066713
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Exploratory Clinical Study to Evaluate the Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction (CMD) and Without Obstructive Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03508609
- Acronym / sponsor ID
- CLBS16-P01
- Conditions
- Coronary Microvascular Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lisata Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Cedars-Sinai Medical Center, Mayo Clinic
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Posted 8 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo selected CD34 cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single intracoronary infusion of CLBS16.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous CD34 cells | Experimental | Biological: CLBS16Open label active treatment arm. Subjects receive autologous CD34 cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women age ≥18
- History of and currently experiencing angina at least 3 times per week
- No obstructive coronary artery disease
- On stable medical therapy for 30 days prior to enrollment
- Must agree to use a reliable and acceptable method of contraception for the duration of participation
Key exclusion criteria (13 listed)
- Myocardial infarction within 90 days
- Prior evidence of obstructive heart disease including PCI or CABG (or planned PCI or CABG)
- Diagnosis of other specific cardiac disease
- Must meet LVEF and GFR requirements
- Current use of coumadin or DOACs
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 |
|---|---|---|
| CLBS16GCSF-mobilized autologous CD34 cells | Biological | Autologous CD34 cells |
Primary outcome
Change From Baseline in Coronary Flow Reserve
Time frame: Day 180
Coronary Flow Reserve (CFR) is a measure of coronary microvascular function.
6 secondary outcomes
Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine
Time frame: Day 180
Change From Baseline in Peripheral Arterial Tonometry
Time frame: Day 180
Change in Angina Frequency From Baseline
Time frame: 6 months
Canadian Cardiovascular Society Angina Class
Time frame: 6 months
Change From Baseline in Seattle Angina Questionnaire
Time frame: 6 months
Change From Baseline in SF-36 Scores
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35067072Henry TD, Bairey Merz CN, Wei J, Corban MT, Quesada O, Joung S, Kotynski CL, Wang J, Lewis M, Schumacher AM, Bartel RL, Takagi H, Shah V, Lee A, Sietsema WK, Losordo DW, Lerman A. Autologous CD34+ Stem Cell Therapy Increases Coronary Flow Reserve and Reduces Angina in Patients With Coronary Microvascular Dysfunction. Circ Cardiovasc Interv. 2022 Feb;15(2):e010802. doi: 10.1161/CIRCINTERVENTIONS.121.010802. Epub 2022 Jan 23.
- Derived from this study: PubMed 34066713Rai B, Shukla J, Henry TD, Quesada O. Angiogenic CD34 Stem Cell Therapy in Coronary Microvascular Repair-A Systematic Review. Cells. 2021 May 8;10(5):1137. doi: 10.3390/cells10051137.
- 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.
Douglas W. Losordo, MD study director
Chief Medical Officer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CLBS16 in people with Coronary Microvascular Dysfunction, run by Lisata Therapeutics, Inc. at 2 sites 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 6 inclusion and 13 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 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Coronary Flow Reserve (time frame: Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03508609, which also lists 2 linked publications.
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 8 Jan 2021.