| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ischemic Heart Disease Non-ischemic Cardiomyopathy | Biological: Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) Other: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of the Safety and Efficacy of Intravenous Delivery of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients and Implanted Left Ventricular Assist Device |
| Actual Study Start Date : | May 3, 2019 |
| Estimated Primary Completion Date : | May 2021 |
| Estimated Study Completion Date : | June 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
Three intravenous infusions of 1.5 million (aMBMC) per kg administered at approximately 2mL/min. Maximum dose as for 100kg subject or 150 million cells for any subject 100kg or more with each infusion 1 month apart.
|
Biological: Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg
|
|
Placebo Comparator: Placebo
Three intravenous infusions of 1.5 mL/kg Lactated Ringer's Solution with each infusion 1 month apart.
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Other: Placebo
1.5 mL/kg Lactated Ringer's Solution
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Clinically significant hematologic, hepatic, or renal impairment as determined by screening clinical laboratory tests within the last 30 days:
Liver disease = ALT or AST > 3x normal, alkaline phosphatase or bilirubin >2x normal Renal disease = on long term dialysis Hematologic = Unexplained persistent leukocytosis (WBC >11 K/UL) or hemoglobin < 8.5 gm/dl
| United States, District of Columbia | |
| MedStar Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 1, 2019 | ||||
| First Posted Date ICMJE | April 24, 2019 | ||||
| Last Update Posted Date | December 17, 2020 | ||||
| Actual Study Start Date ICMJE | May 3, 2019 | ||||
| Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Serial Infusions of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients With Left Ventricular Assist Device | ||||
| Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of the Safety and Efficacy of Intravenous Delivery of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients and Implanted Left Ventricular Assist Device | ||||
| Brief Summary | A study to assess the safety and preliminary efficacy of serial intravenous dose of Allogeneic Mesenchymal Bone Marrow Cells in subjects with heart failure and implanted left ventricular assist devices. | ||||
| Detailed Description | A double-blind, placebo-controlled, single-center, randomized study to assess the safety and preliminary efficacy of a three serial intravenous doses of allogeneic mesenchymal bone marrow cells to subjects with heart failure and implanted left ventricular assist devices. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE |
30 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | June 2021 | ||||
| Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03925324 | ||||
| Other Study ID Numbers ICMJE | STEMVAD-001 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Medstar Health Research Institute | ||||
| Study Sponsor ICMJE | Medstar Health Research Institute | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Medstar Health Research Institute | ||||
| Verification Date | December 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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