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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44HL135889-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Cedars-Sinai Medical Center | OTHER |
| Mayo Clinic | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous CD34 cells | Experimental | Open label active treatment arm. Subjects receive autologous CD34 cells. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLBS16 | Biological | GCSF-mobilized autologous CD34 cells |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Coronary Flow Reserve | Coronary Flow Reserve (CFR) is a measure of coronary microvascular function. | Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine | Day 180 | |
| Change From Baseline in Peripheral Arterial Tonometry | Day 180 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas W. Losordo, MD | Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Mayo Clinic in Rochester |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35067072 | Derived | 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. | |
| 34066713 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Autologous CD34 Cells | Open label active treatment arm. Subjects receive autologous CD34 cells. CLBS16: GCSF-mobilized autologous CD34 cells |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 26, 2019 | Nov 17, 2020 |
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| Change in Angina Frequency From Baseline |
| 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. | 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). | 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. | 6 months |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Autologous CD34 Cells | Open label active treatment arm. Subjects receive autologous CD34 cells. CLBS16: GCSF-mobilized autologous CD34 cells |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kg |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Coronary Flow Reserve | Coronary Flow Reserve (CFR) is a measure of coronary microvascular function. | Posted | Mean | Standard Deviation | ratio | Day 180 |
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| Secondary | Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine | Posted | Mean | Standard Deviation | % change in peak coronary blood flow | Day 180 |
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| Secondary | Change From Baseline in Peripheral Arterial Tonometry | Posted | Mean | Standard Deviation | Reactive Hyperemia Index (ratio) | Day 180 |
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| Secondary | Change in Angina Frequency From Baseline | Posted | Mean | Standard Deviation | angina episodes per day | 6 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | change in grade | 6 months |
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| Secondary | 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). | Posted | Mean | Standard Deviation | change in scale score | 6 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | change in scale score | 6 months |
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1 year
Adverse events were solicited from all subjects at each visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Autologous CD34 Cells | Open label active treatment arm. Subjects receive autologous CD34 cells. CLBS16: GCSF-mobilized autologous CD34 cells | 0 | 20 | 6 | 20 | 20 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | Systematic Assessment |
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| Coronary artery dissection | Injury, poisoning and procedural complications | Systematic Assessment |
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| Ventricular fibrillation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Hepatitis acute | Hepatobiliary disorders | Systematic Assessment |
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| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | Systematic Assessment |
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| Catheter site pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hepatic enzyme increased | Hepatobiliary disorders | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | Systematic Assessment |
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| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Fatigue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Sietsema | Caladrius Biosciences, Inc. | 9495352391 | bsietsema@caladrius.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 25, 2020 | Nov 17, 2020 | SAP_001.pdf |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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