Trial Outcomes & Findings for Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease (NCT NCT03508609)

NCT ID: NCT03508609

Last Updated: 2021-01-08

Results Overview

Coronary Flow Reserve (CFR) is a measure of coronary microvascular function.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: Day 180
• Results posted on: 2021-01-08

Participant Flow

Participant milestones

Measure	Autologous CD34 Cells Open label active treatment arm. Subjects receive autologous CD34 cells. CLBS16: GCSF-mobilized autologous CD34 cells
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Autologous CD34 Cells Open label active treatment arm. Subjects receive autologous CD34 cells. CLBS16: GCSF-mobilized autologous CD34 cells
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Autologous CD34 Cells n=20 Participants Open label active treatment arm. Subjects receive autologous CD34 cells. CLBS16: GCSF-mobilized autologous CD34 cells
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	54.3 years STANDARD_DEVIATION 12.72 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Weight	83.36 kg STANDARD_DEVIATION 23.377 • n=5 Participants
Body Mass Index	29.52 kg/m^2 STANDARD_DEVIATION 7.322 • n=5 Participants

PRIMARY outcome

Timeframe: Day 180

Coronary Flow Reserve (CFR) is a measure of coronary microvascular function.

Outcome measures

Measure	Autologous CD34 Cells n=20 Participants Open label active treatment arm. Subjects receive autologous CD34 cells. CLBS16: GCSF-mobilized autologous CD34 cells
Change From Baseline in Coronary Flow Reserve	0.62 ratio Standard Deviation 0.835

SECONDARY outcome

Timeframe: Day 180

Outcome measures

Measure	Autologous CD34 Cells n=20 Participants Open label active treatment arm. Subjects receive autologous CD34 cells. CLBS16: GCSF-mobilized autologous CD34 cells
Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine	9.4 % change in peak coronary blood flow Standard Deviation 105.408

SECONDARY outcome

Timeframe: Day 180

Outcome measures

Measure	Autologous CD34 Cells n=20 Participants Open label active treatment arm. Subjects receive autologous CD34 cells. CLBS16: GCSF-mobilized autologous CD34 cells
Change From Baseline in Peripheral Arterial Tonometry	-0.19 Reactive Hyperemia Index (ratio) Standard Deviation 0.990

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Autologous CD34 Cells n=20 Participants Open label active treatment arm. Subjects receive autologous CD34 cells. CLBS16: GCSF-mobilized autologous CD34 cells
Change in Angina Frequency From Baseline	-2.34 angina episodes per day Standard Deviation 2.938

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	Autologous CD34 Cells n=20 Participants Open label active treatment arm. Subjects receive autologous CD34 cells. CLBS16: GCSF-mobilized autologous CD34 cells
Canadian Cardiovascular Society Angina Class	-1.21 change in grade Standard Deviation 1.032

SECONDARY outcome

Timeframe: 6 months

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).

Outcome measures

Measure	Autologous CD34 Cells n=20 Participants Open label active treatment arm. Subjects receive autologous CD34 cells. CLBS16: GCSF-mobilized autologous CD34 cells
Change From Baseline in Seattle Angina Questionnaire Physical limitation scale	16.81 change in scale score Standard Deviation 20.956
Change From Baseline in Seattle Angina Questionnaire Angina stability scale	23.61 change in scale score Standard Deviation 40.649
Change From Baseline in Seattle Angina Questionnaire Angina frequency scale	18.33 change in scale score Standard Deviation 28.952
Change From Baseline in Seattle Angina Questionnaire Treatment satisfaction scale	12.83 change in scale score Standard Deviation 19.925
Change From Baseline in Seattle Angina Questionnaire Disease perception scale	23.68 change in scale score Standard Deviation 24.417

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	Autologous CD34 Cells n=20 Participants Open label active treatment arm. Subjects receive autologous CD34 cells. CLBS16: GCSF-mobilized autologous CD34 cells
Change From Baseline in SF-36 Scores Physical component scores	6.66 change in scale score Standard Deviation 7.452
Change From Baseline in SF-36 Scores Mental component scores	5.62 change in scale score Standard Deviation 8.628
Change From Baseline in SF-36 Scores Physical function	5.94 change in scale score Standard Deviation 6.439
Change From Baseline in SF-36 Scores Role-physical	9.81 change in scale score Standard Deviation 10.376
Change From Baseline in SF-36 Scores Bodily pain	5.50 change in scale score Standard Deviation 6.681
Change From Baseline in SF-36 Scores General health	3.53 change in scale score Standard Deviation 6.666
Change From Baseline in SF-36 Scores Vitality	8.29 change in scale score Standard Deviation 8.666
Change From Baseline in SF-36 Scores Social functions	7.91 change in scale score Standard Deviation 8.573
Change From Baseline in SF-36 Scores Role-emotional	6.23 change in scale score Standard Deviation 11.287
Change From Baseline in SF-36 Scores Mental health	4.13 change in scale score Standard Deviation 7.766

Adverse Events

Autologous CD34 Cells

Serious events: 6 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Autologous CD34 Cells n=20 participants at risk Open label active treatment arm. Subjects receive autologous CD34 cells. CLBS16: GCSF-mobilized autologous CD34 cells
Cardiac disorders Acute coronary syndrome	5.0% 1/20 • 1 year Adverse events were solicited from all subjects at each visit.
Cardiac disorders Angina pectoris	5.0% 1/20 • 1 year Adverse events were solicited from all subjects at each visit.
Injury, poisoning and procedural complications Coronary artery dissection	5.0% 1/20 • 1 year Adverse events were solicited from all subjects at each visit.
Injury, poisoning and procedural complications Ventricular fibrillation	5.0% 1/20 • 1 year Adverse events were solicited from all subjects at each visit.
Nervous system disorders Dizziness	5.0% 1/20 • 1 year Adverse events were solicited from all subjects at each visit.
Nervous system disorders Syncope	5.0% 1/20 • 1 year Adverse events were solicited from all subjects at each visit.
Hepatobiliary disorders Hepatitis acute	5.0% 1/20 • 1 year Adverse events were solicited from all subjects at each visit.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	5.0% 1/20 • 1 year Adverse events were solicited from all subjects at each visit.
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 1/20 • 1 year Adverse events were solicited from all subjects at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	5.0% 1/20 • 1 year Adverse events were solicited from all subjects at each visit.

Other adverse events

Measure	Autologous CD34 Cells n=20 participants at risk Open label active treatment arm. Subjects receive autologous CD34 cells. CLBS16: GCSF-mobilized autologous CD34 cells
Musculoskeletal and connective tissue disorders Bone Pain	55.0% 11/20 • 1 year Adverse events were solicited from all subjects at each visit.
Gastrointestinal disorders Nausea	45.0% 9/20 • 1 year Adverse events were solicited from all subjects at each visit.
Nervous system disorders Headache	30.0% 6/20 • 1 year Adverse events were solicited from all subjects at each visit.
General disorders Pain	30.0% 6/20 • 1 year Adverse events were solicited from all subjects at each visit.
Cardiac disorders Angina pectoris	30.0% 6/20 • 1 year Adverse events were solicited from all subjects at each visit.
Nervous system disorders Dizziness	25.0% 5/20 • 1 year Adverse events were solicited from all subjects at each visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 4/20 • 1 year Adverse events were solicited from all subjects at each visit.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	20.0% 4/20 • 1 year Adverse events were solicited from all subjects at each visit.
Gastrointestinal disorders Paraesthesia oral	20.0% 4/20 • 1 year Adverse events were solicited from all subjects at each visit.
Injury, poisoning and procedural complications Catheter site pain	15.0% 3/20 • 1 year Adverse events were solicited from all subjects at each visit.
Hepatobiliary disorders Hepatic enzyme increased	15.0% 3/20 • 1 year Adverse events were solicited from all subjects at each visit.
Nervous system disorders Paraesthesia	15.0% 3/20 • 1 year Adverse events were solicited from all subjects at each visit.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	15.0% 3/20 • 1 year Adverse events were solicited from all subjects at each visit.
Musculoskeletal and connective tissue disorders Back pain	10.0% 2/20 • 1 year Adverse events were solicited from all subjects at each visit.
Musculoskeletal and connective tissue disorders Fatigue	10.0% 2/20 • 1 year Adverse events were solicited from all subjects at each visit.
General disorders Pyrexia	10.0% 2/20 • 1 year Adverse events were solicited from all subjects at each visit.

Additional Information

William Sietsema

Caladrius Biosciences, Inc.

Phone: 9495352391

Email: bsietsema@caladrius.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place