Ischemic Heart DiseasePhase 2STEM-VADNCT03925324
Serial Infusions of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients With Left Ventricular Assist Device
A Phase 2 study testing Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) in people with Ischemic Heart Disease and Non-ischemic Cardiomyopathy, run by Medstar Health Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Non-ischemic Cardiomyopathy
- What is being tested?
- Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2019to 16 Aug 2021
- 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
- Age ≥18 years.
- Advanced Heart Failure
- Advanced HF defined as HF requiring LVAD implantation and deemed stable on his/her LVAD.
- On stable medical therapy (per the discretion of the treating physician) including beta-blockers, ACE-inhibitors, angiotensin receptors blockers, angiotensin receptor neprilysin inhibitor, mineralocorticoid receptor antagonists, isosorbide, hydralazine, and mineralocorticoid receptor antagonists) and optimized pump speed for at least a month prior to randomization.
- HS-CRP level≥2 mg/l.
- NYHA class II-III symptoms.
- Ability to understand and provide signed informed consent.
- Reasonable expectation that patient will receive standard post-treatment care and attend all scheduled safety follow-up visits
Who cannot join
- Women of childbearing potential. Postmenopausal women or women with permanent contraception method (defined as total hysterectomy) will not be excluded.
- History of debilitating stroke (modified Rankin Score > 3) within 3 months.
- The likelihood of requirement of cardiac surgery during the study period.
- Presence of clinically significant, uncorrected left sided valvular heart disease, active acute myocarditis, or uncontrolled hypertension defined as Persistently elevated mean arterial blood pressure (>100 mmHg). Echocardiography within 12 months of screening. Patients can be re-evaluated, at the discretion of the investigator.
- QTc >550 ms (in the absence of bundle branch block, interventricular conduction delay or ventricular pacing). Electrocardiogram (ECG) within 60 days.
- History of cardiac arrest within 3 months.
Show all 27Show fewer
- Hypertrophic or infiltrative cardiomyopathy.
- Considered or listed for organ transplantation or history of organ transplantation
- Illness other than HF with life expectancy less than 12 months.
- Enrolled in an interventional trial or received an experimental drug or device within 30 days of randomization.
- Left ventricular assist device implantation >2 years prior to enrollment.
- Biventricular assist device (Bi-VAD) support.
- Severe COPD defined by FEV1<1L, FEV1/FVC<70% within 12 months if known history of COPD, otherwise FEV1<1L, FEV1/FVC<70% within 24 months
- Uncontrolled seizure disorder.
- 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
- Presence of any other clinically-significant medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the investigator or sponsor may affect compliance with the study protocol or pose a safety risk to the subject.
- Inability to comply with the conditions of the protocol.
- Acute coronary syndrome within 4 weeks (clinical diagnosis, confirmed by electrocardiographic abnormalities and elevation of troponin-I).
- Malignancy within the previous five years, except adequately treated basal cell carcinoma, provided that it is neither infiltrating nor sclerosing, and carcinoma in situ of the cervix.
- Active uncontrolled systemic infection. Positive blood or deep tissue cultures or clinical or imaging evidence of systemic infection despite complete course of effective antimicrobial therapy as determined by infectious diseases. Localized (non-systemic) infection is not an exclusion criterion. Patients can be re-evaluated, at the discretion of the investigator.
- Early postpartum cardiomyopathy (within six months of diagnosis).
- Presence of inherited or acquired immune deficiency or human immunodeficiency virus infection (HIV). Negative HIV test within the preceding 12 months is required.
- Systemic corticosteroids, immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, tacrolimus, azathioprine, mycophenolate, sirolimus, etc.), and DNA depleting or cytotoxic drugs taken within four weeks prior to study treatment.
- Known Porphyria.
- Allergy to sodium citrate or any caine type of local anesthetic.
- Patient enrolled in hospice care.
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
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
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.
Read the 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.
- Being tested
- Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC), Placebo
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)Biological
Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg
PlaceboOther
1.5 mL/kg Lactated Ringer's Solution
| Study group | Role | What they receive |
|---|---|---|
| Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) | Experimental | 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. Receives: Biological: Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) |
| Placebo | Placebo comparator | Three intravenous infusions of 1.5 mL/kg Lactated Ringer's Solution with each infusion 1 month apart. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Temperature
Measured: up to 12 months post enrollment
Uncontrolled Systemic Infection
Number of admission for uncontrolled systemic infection
Measured: up to 12 months post enrollment
All-cause Mortality
Rate of Death
Measured: up to 12 months post enrollment
Secondary outcomes (6)
NK Cell Depletion
percent reduction in NK cells
Measured: Baseline to day 90
Change in the Following Cardiac Biomarker
The change in the lab values N-Terminal Prohormone of Brain Natriuretic Peptide (NT-ProBNP)
Measured: Baseline and day 90 post initial infusion
Change in RV Systolic Function
Change in RV systolic function
Measured: Baseline and day 90 post initial infusion
Hospitalizations Due to Right Heart Failure
Number of hospitalizations for to right heart failure
Measured: day 90
6 Minute Walk Distance Changes
6 minute walk distance changes
Measured: Baseline and day 90 post initial infusion
Gout Flares
Count of gout flares
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start3 May 2019
- Primary completion16 Aug 2021
- Study completion16 Aug 2021
Why it stopped: Lack of funding/Covid-19
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.
- Other trials for Ischemic Heart DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925324
- Sponsor's protocol ID
- STEMVAD-001
- Acronym
- STEM-VAD
- Status last verified
- Jan 2022
- First submitted
- 1 Apr 2019
- Last updated
- 2 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03925324
- Acronym / sponsor ID
- STEM-VAD / STEMVAD-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding/Covid-19
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 3 May 2019 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Posted 2 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) | Experimental | Biological: 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. |
| Placebo | Placebo comparator | Other: PlaceboThree intravenous infusions of 1.5 mL/kg Lactated Ringer's Solution with each infusion 1 month apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years.
- Advanced Heart Failure
- Advanced HF defined as HF requiring LVAD implantation and deemed stable on his/her LVAD.
- On stable medical therapy (per the discretion of the treating physician) including beta-blockers, ACE-inhibitors, angiotensin receptors blockers, angiotensin receptor neprilysin inhibitor, mineralocorticoid receptor antagonists, isosorbide, hydralazine, and mineralocorticoid receptor antagonists) and optimized pump speed for at least a month prior to randomization.
- HS-CRP level≥2 mg/l.
Key exclusion criteria (27 listed)
- Women of childbearing potential. Postmenopausal women or women with permanent contraception method (defined as total hysterectomy) will not be excluded.
- History of debilitating stroke (modified Rankin Score > 3) within 3 months.
- The likelihood of requirement of cardiac surgery during the study period.
- Presence of clinically significant, uncorrected left sided valvular heart disease, active acute myocarditis, or uncontrolled hypertension defined as Persistently elevated mean arterial blood pressure (>100 mmHg). Echocardiography within 12 months of screening. Patients can be re-evaluated, at the discretion of the investigator.
- QTc >550 ms (in the absence of bundle branch block, interventricular conduction delay or ventricular pacing). Electrocardiogram (ECG) within 60 days.
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 |
|---|---|---|
| Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg | Biological | Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) |
| Placebo1.5 mL/kg Lactated Ringer's Solution | Other | Placebo |
Primary outcome
Temperature
Time frame: up to 12 months post enrollment
Temperature
Uncontrolled Systemic Infection
Time frame: up to 12 months post enrollment
Number of admission for uncontrolled systemic infection
All-cause Mortality
Time frame: up to 12 months post enrollment
Rate of Death
6 secondary outcomes
NK Cell Depletion
Time frame: Baseline to day 90
Change in the Following Cardiac Biomarker
Time frame: Baseline and day 90 post initial infusion
Change in RV Systolic Function
Time frame: Baseline and day 90 post initial infusion
Hospitalizations Due to Right Heart Failure
Time frame: day 90
6 Minute Walk Distance Changes
Time frame: Baseline and day 90 post initial infusion
Gout Flares
Time frame: Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) in people with Ischemic Heart Disease and Non-ischemic Cardiomyopathy, run by Medstar Health Research Institute at 1 site 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 8 inclusion and 27 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: stopped early, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 2 Feb 2022). 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?
Temperature (time frame: up to 12 months post enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2022.