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Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease

Primary Purpose

Coronary Microvascular Dysfunction

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CLBS16
Sponsored by
Lisata Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Microvascular Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Cedars-Sinai Medical Center
  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous CD34 cells

Arm Description

Open label active treatment arm. Subjects receive autologous CD34 cells.

Outcomes

Primary Outcome Measures

Change From Baseline in Coronary Flow Reserve
Coronary Flow Reserve (CFR) is a measure of coronary microvascular function.

Secondary Outcome Measures

Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine
Change From Baseline in Peripheral Arterial Tonometry
Change in Angina Frequency From Baseline
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.
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).
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.

Full Information

First Posted
April 16, 2018
Last Updated
December 11, 2020
Sponsor
Lisata Therapeutics, Inc.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Cedars-Sinai Medical Center, Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03508609
Brief Title
Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 19, 2018 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
May 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lisata Therapeutics, Inc.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Cedars-Sinai Medical Center, Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Microvascular Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous CD34 cells
Arm Type
Experimental
Arm Description
Open label active treatment arm. Subjects receive autologous CD34 cells.
Intervention Type
Biological
Intervention Name(s)
CLBS16
Intervention Description
GCSF-mobilized autologous CD34 cells
Primary Outcome Measure Information:
Title
Change From Baseline in Coronary Flow Reserve
Description
Coronary Flow Reserve (CFR) is a measure of coronary microvascular function.
Time Frame
Day 180
Secondary Outcome Measure Information:
Title
Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine
Time Frame
Day 180
Title
Change From Baseline in Peripheral Arterial Tonometry
Time Frame
Day 180
Title
Change in Angina Frequency From Baseline
Time Frame
6 months
Title
Canadian Cardiovascular Society Angina Class
Description
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.
Time Frame
6 months
Title
Change From Baseline in Seattle Angina Questionnaire
Description
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).
Time Frame
6 months
Title
Change From Baseline in SF-36 Scores
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas W. Losordo, MD
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35067072
Citation
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.
Results Reference
derived
PubMed Identifier
34066713
Citation
Rai 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.
Results Reference
derived

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Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease

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