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Stem Cell TransplantationPhase 1/2NCT01087996

The Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis Pilot Study (The POSEIDON-Pilot Study)

A Phase 1/2 study testing Auto-hMSCs and Allo-hMSCs in people with Stem Cell Transplantation, run by University of Miami at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The technique of transplanting progenitor cells into a region of damaged myocardium, termed cellular cardiomyoplasty, is a potentially new therapeutic modality designed to replace or repair necrotic, scarred, or dysfunctional myocardium. Read more about this study

Who is it for?
Ages 21 to 90 years
Conditions the study is for
Stem Cell Transplantation
What is being tested?
Auto-hMSCs and Allo-hMSCs
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
2 sitesUnited States
Study dates
Mar 2010to Oct 2012
Phase
Phase 1/2
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 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of chronic ischemic left ventricular dysfunction secondary to MI.
  • Be a candidate for cardiac catheterization.
  • Been treated with appropriate maximal medical therapy for heart failure or post-infarction left ventricular dysfunction.
  • Ejection fraction between 20% and 50%.
  • Able to perform a metabolic stress test.

Who cannot join

  • Baseline glomerular filtration rate <50 ml/min/1.73m2.
  • Presence of a mechanical aortic valve or heart constrictive device.
  • Documented presence of aortic stenosis (aortic stenosis graded as ≥+2 equivalent to an orifice area of 1.5cm2 or less).
  • Documented presence of moderate to severe aortic insufficiency (echocardio- graphic assessment of aortic insufficiency graded as ≥+2).
  • Evidence of a life-threatening arrhythmia (nonsustained ventricular tachycardia ≥20 consecutive beats or complete heart block) or QTc interval >550 ms on screening ECG. In addition; patients with sustained or a short run of ventricular tachycardia on ECG or 48 hour Ambulatory ECG during the screening period will be removed from the protocol.
  • Documented unstable angina.
Show all 19Show fewer
  • AICD firing in the past 60 days prior to the procedure.
  • Be eligible for or require coronary artery revascularization.
  • Have a hematologic abnormality as evidenced by hematocrit < 25%, white blood cell < 2,500/ul or platelet values < 100,000/ul without another explanation.
  • Have liver dysfunction, as evidenced by enzymes (ALT and AST) greater than three times the ULN.
  • Have a coagulopathy condition = (INR > 1.3) not due to a reversible cause.
  • Known, serious radiographic contrast allergy.
  • Known allergies to penicillin or streptomycin.
  • Organ transplant recipient.
  • Clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
  • Non-cardiac condition that limits lifespan to < 1 year.
  • On chronic therapy with immunosuppressant medication.
  • Serum positive for HIV, hepatitis BsAg, or hepatitis C.
  • Female patient who is pregnant, nursing, or of child-bearing potential and not using effective birth control.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Johns Hopkins University

    Baltimore, Maryland

  • University of Miami Miller School of Medicine

    Miami, Florida

Other trials in United States

About this study

Official title: A Phase I/II, Randomized Pilot Study of the Comparative Safety and Efficacy of Transendocardial Injection of Autologous Mesenchymal Stem Cells Versus Allogeneic Mesenchymal Stem Cells in Patients With Chronic Ischemic Left Ventricular Dysfunction Secondary to Myocardial Infarction

The technique of transplanting progenitor cells into a region of damaged myocardium, termed cellular cardiomyoplasty, is a potentially new therapeutic modality designed to replace or repair necrotic, scarred, or dysfunctional myocardium. Ideally, graft cells should be readily available, easy to culture to ensure adequate quantities for transplantation, and able to survive in host myocardium; often a hostile environment of limited blood supply and immunorejection. Whether effective cellular regenerative strategies require that administered cells differentiate into adult cardiomyocytes and couple electromechanically with the surrounding myocardium is increasingly controversial, and recent evidence suggests that this may not be required for effective cardiac repair. Most importantly, transplantation of graft cells should improve cardiac function and prevent adverse ventricular remodeling. To date, a number of candidate cells have been transplanted in experimental models, including fetal and neonatal cardiomyocytes, embryonic stem cell-derived myocytes, tissue engineered contractile grafts, skeletal myoblasts, several cell types derived from adult bone marrow, and cardiac precursors residing within the heart itself. There has been substantial clinical development in the use of whole bone marrow and skeletal myoblast preparations in studies enrolling both post-infarction patients, and patients with chronic ischemic left ventricular dysfunction and heart failure. The effects of bone-marrow derived mesenchymal stem cells (MSCs) have also been studied clinically.

Currently, bone marrow or bone marrow-derived cells represent highly promising modality for cardiac repair. The totality of evidence from trials investigating autologous whole bone marrow infusions into patients following myocardial infarction supports the safety of this approach. In terms of efficacy, increases in ejection fraction are reported in the majority of the trials.

Chronic ischemic left ventricular dysfunction resulting from heart disease is a common and problematic condition; definitive therapy in the form of heart transplantation is available to only a tiny minority of eligible patients. Cellular cardiomyoplasty for chronic heart failure has been studied less than for acute MI, but represents a potentially important alternative for this disease.

Being tested
Auto-hMSCs, Allo-hMSCs
Keywords
Chronic Ischemic Left Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Auto-hMSCsBiological

    Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.

  • Allo-hMSCsBiological

    Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.

Study groups in NCT01087996
Study groupRoleWhat they receive
Auto-hMSCsExperimentalParticipants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Receives: Biological: Auto-hMSCs
Allo-hMSCsExperimentalParticipants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Receives: Biological: Allo-hMSCs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation

    Measured: One month post-catheterization

Secondary outcomes (8)

  1. CT Infarct Size From Early Enhanced Defect: - Difference Between the Baseline and 13-month

    Percentage change from 13-months post-catheterization to baseline.

    Measured: Baseline Month 13 post-catheterization

  2. CT Measure of Left Ventricular Ejection Fraction

    Measured: Baseline Month 13 post-catheterization

  3. CT Measure of End Diastolic Volume

    Measured: Baseline Month 13 post-catheterization

  4. CT Measure of End Systolic Volume

    Measured: Baseline Month 13 post-catheterization

  5. CT Measure of Scar Size as % of LV Mass

    Measured: Baseline Month 13 post-catheterization

  6. Change in Distance Walked in 6-minutes From Baseline.

    Measured: 12-months

  7. Change in Minnesota Living With Heart Failure Total Score

    The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life.

    Measured: 12 months

  8. Change in New York Heart Association Class at 12-months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionApr 2011
  4. Study completionOct 2012

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01087996
Sponsor's protocol ID
20090352
Other IDs
R01HL110737, R01HL107110, R01HL084275, P20HL101443, R01HL094849
Status last verified
May 2015
First submitted
15 Mar 2010
Last updated
27 May 2015
Data monitoring committee
Yes

Publications

  • Hare JM, Fishman JE, Gerstenblith G, DiFede Velazquez DL, Zambrano JP, Suncion VY, Tracy M, Ghersin E, Johnston PV, Brinker JA, Breton E, Davis-Sproul J, Schulman IH, Byrnes J, Mendizabal AM, Lowery MH, Rouy D, Altman P, Wong Po Foo C, Ruiz P, Amador A, Da Silva J, McNiece IK, Heldman AW, George R, Lardo A. Comparison of allogeneic vs autologous bone marrow-derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial. JAMA. 2012 Dec 12;308(22):2369-79. doi: 10.1001/jama.2012.25321.

    PubMed 23117550

  • Tompkins BA, Rieger AC, Florea V, Banerjee MN, Natsumeda M, Nigh ED, Landin AM, Rodriguez GM, Hatzistergos KE, Schulman IH, Hare JM. Comparison of Mesenchymal Stem Cell Efficacy in Ischemic Versus Nonischemic Dilated Cardiomyopathy. J Am Heart Assoc. 2018 Jul 12;7(14):e008460. doi: 10.1161/JAHA.117.008460.

    PubMed 30005555

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Auto-hMSCs and Allo-hMSCs in people with Stem Cell Transplantation, run by University of Miami at 2 sites 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 5 inclusion and 19 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: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 27 May 2015). 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?

Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation (time frame: One month post-catheterization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01087996, which also lists 2 linked publications.

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 27 May 2015.

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