Non-ischemic Dilated CardiomyopathyPhase 1/2PoseidonDCMNCT01392625

PercutaneOus StEm Cell Injection Delivery Effects On Neomyogenesis in Dilated CardioMyopathy (The POSEIDON-DCM Study)

A Phase 1/2 study testing Autologous hMSCs and Allogeneic hMSCs in people with Non-ischemic Dilated Cardiomyopathy, run by Joshua M Hare at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 95 years
Conditions the study is for: Non-ischemic Dilated Cardiomyopathy
What is being tested?: Autologous hMSCs and Allogeneic hMSCs
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: 19 May 2011to 28 Aug 2017
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 18 to 95 years
All sexes
No healthy volunteers
Adult, Older adult

Major Inclusion Criteria:

Be ≥ 18 and < 95 years of age.
Provide written informed consent.
Diagnosis of nonischemic dilated cardiomyopathy.
Be a candidate for cardiac catheterization within 5 to 10 weeks of screening.
Been treated with appropriate maximal medical therapy for heart failure.
Ejection fraction below 40% and either a left ventricular end diastolic diameter (LVEDD) > 5.9cm in male subjects, an LVEDD of > 5.6cm in female subjects or left ventricular end diastolic volume index > 125 mL/m2
Be able to undergo an MRI or CT.

Major Exclusion Criteria:

Baseline glomerular filtration rate equal or < 45 ml/min/1.73m2.
Be eligible for or require standard-of-care surgical or percutaneous intervention for the treatment of nonischemic dilated cardiomyopathy.
Presence of a prosthetic aortic valve or heart constrictive device.
Presence of a prosthetic mitral valve.
Previous myocardial infarction (MI) as documented by a clinical history that will include an elevation of cardiac enzymes and/or ECG changes consistent with MI.
Diagnosis of nonischemic dilated cardiomyopathy due to valvular dysfunction, mitral regurgitation, tachycardia, or myocarditis.
Previous treatment for post-infarction left ventricular dysfunction including PCI and thrombolytic therapy.
Documented presence of a known LV thrombus, aortic dissection, or aortic aneurysm.
Documented presence of epicardial stenosis of 70% or greater in one or more major epicardial coronary arteries.
Documented presence of aortic stenosis (aortic stenosis graded as 1.5cm2 or less).
Documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2).
Evidence of a life-threatening arrhythmia in the absence of a defibrillator (nonsustained ventricular tachycardia ≥ 20 consecutive beats or complete second or third degree heart block in the absence of a functioning pacemaker) or QTc interval > 550 ms on screening ECG.
AICD firing in the past 30 days prior to the procedure
Be eligible for or require coronary artery revascularization.
Diabetic with poorly controlled blood glucose levels and/or evidence of proliferative retinopathy.
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.
Have a history of organ or cell transplant rejection
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 viremic hepatitis C.
Female patient who is pregnant, nursing, or of child-bearing potential and not using effective birth control.
Have a history of drug or alcohol abuse within the past 24 months.
Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami School of Medicine
Miami, Florida, 33136

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 Non-ischemic Dilated Cardiomyopathy.

The technique of transplanting progenitor cells into a region of damaged myocardium, termed cellular cardiomyoplasty1, is a potentially new therapeutic modality designed to replace or repair necrotic, scarred, or dysfunctional myocardium2-4. 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 cardiomyocytes5, embryonic stem cell-derived myocytes6, 7, tissue engineered contractile grafts8, skeletal myoblasts9, several cell types derived from adult bone marrow10-15, and cardiac precursors residing within the heart itself16. 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.

Non-ischemic dilated cardiomyopathy 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.

Read the detailed description

This is a Pilot Study, intended as a safety assessment prior to a full comparator study. In this Pilot Study, cells administered via the Biosense Webster MyoStar NOGA injection catheter system will be tested in 36 patients in two groups:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 X 108 (100 million) Auto-hMSCs.

Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 X 108 (100 million) Auto-hMSCs.

The first three (3) patients in each group (Group 1 and Group 2) will not be treated less than 5 days apart and will each undergo full evaluation for 5 days to demonstrate there is no evidence of a procedure induced myocardial infarction or myocardial perforation prior to proceeding with the treatment of further patients.

Patients will be randomized in a 1:1 ratio to one of the two groups.

Treatment Strategies: Autologous hMSCs vs. Allogeneic hMSCs. The Study Team will record and maintain a detailed record of injection locations.

If a patient is randomized to Groups 1 (Auto-hMSCs) and the Auto-hMSCs do not expand to the required dose of 1 X 108 cells, each injection will contain the maximum number of cells available.

The injections will be administered transendocardially during cardiac catheterization using the Biosense Webster MyoStar NOGA Catheter System.

For patients randomized to Group 1(Auto-hMSCs); the cells will be derived from a sample of the patient's bone marrow (obtained by iliac crest aspiration) approximately 4-6 weeks prior to cardiac catheterization. For patients randomized to Group 2 (Allo- hMSCs), the cells will be supplied from an allogeneic human mesenchymal stem cell source manufactured by the University of Miami. The Allo-hMSCs for patients in group 2 will be administered after all baseline assessments are completed with an expected range of 2 - 4 weeks post-randomization.

Following cardiac catheterization and cell injections, patients will be hospitalized for a minimum of 2 days then followed at 2 weeks post-catheterization, and at month 2, 3, 6, and 12 to complete all safety and efficacy assessments.

Conditions: Non-ischemic Dilated Cardiomyopathy
Being tested: Autologous hMSCs, Allogeneic hMSCs
Keywords: Non ischemic dilated cardiomyopathy, Dilated cardiomyopathy, Heart failure, Cardiac Stem Cell Transplantation, Stem Cells
Medical subject headings: Cardiomyopathy, Dilated, Heart Failure

What participants receive

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

Autologous hMSCsBiological
Also called Biosense Webster MyoStar NOGA Injection Catheter System.
Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Allogeneic hMSCsBiological
Also called Biosense Webster MyoStar NOGA Injection Catheter System.
Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Study groups in NCT01392625
Study group	Role	What they receive
Autologous hMSCs	Active comparator	Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs. Receives: Biological: Autologous hMSCs
Allogeneic hMSCs	Active comparator	Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs. Receives: Biological: Allogeneic hMSCs

What is being measured

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

Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs)
Incidence of TE-SAEs is defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise), or any other potential late effects detected and corroborated by clinical presentation, laboratory investigations, image analysis and when necessary with biopsy from suspected target sites in the body.
Measured: One month post-catheterization

Secondary outcomes (5)

Measurement of Changes in Peak VO2
Measurement of Peak oxygen consumption (Peak VO2) by treadmill determination during the 12 month follow-up period.
Measured: Baseline, 6 month and 12 month
Measurement of Changes in 6 Minute Walk
Measurement of Six-minute walk test during the 12 month follow-up period
Measured: Baseline, 6 month and 12 month
Measurement of Changes in Global Ejection Fraction
Measurement of regional left ventricular function, end diastolic and end systolic volume, measured by MRI, and or CT, and echocardiogram.
Measured: Baseline, 6 month and 12 month
Measurement of Changes in New York Heart Association (NYHA)
Measurement of New York Heart Association (NYHA) functional class during the 12 month follow-up period.
Measured: Baseline, 6 month and 12 month
Measurement of Changes in Minnesota Living With Heart Failure (MLHF) Questionnaire
Measurement of Minnesota Living with Heart Failure (MLHF) Questionnaire during the 12 month follow-up period. It measures the effects of symptoms, functional limitations, and psychological distress on an individual's quality of life. The response scale for all 21 items on the MLHF is based on a 6-point. The Maximum possible scores being 126 and the minimum 0. Higher scores indicate a worse or worsening quality of life, while lower scores or decreasing scores indicate a better quality of life.
Measured: Baseline, 6 month and 12 month

Timeline

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

19 May 201128 Aug 2017

First posted12 Jul 2011 (estimated)
Study start19 May 2011
Primary completion28 Aug 2016
Study completion28 Aug 2017

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.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Non-ischemic Dilated CardiomyopathyStudies 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01392625
Sponsor's protocol ID: 20100968
Other IDs: 1R01HL110737-01
Acronym: PoseidonDCM
Status last verified: Jan 2018
First submitted: 29 Jun 2011
Last updated: 15 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Williams AR, Trachtenberg B, Velazquez DL, McNiece I, Altman P, Rouy D, Mendizabal AM, Pattany PM, Lopera GA, Fishman J, Zambrano JP, Heldman AW, Hare JM. Intramyocardial stem cell injection in patients with ischemic cardiomyopathy: functional recovery and reverse remodeling. Circ Res. 2011 Apr 1;108(7):792-6. doi: 10.1161/CIRCRESAHA.111.242610. Epub 2011 Mar 17.
PubMed 21415390
Trachtenberg B, Velazquez DL, Williams AR, McNiece I, Fishman J, Nguyen K, Rouy D, Altman P, Schwarz R, Mendizabal A, Oskouei B, Byrnes J, Soto V, Tracy M, Zambrano JP, Heldman AW, Hare JM. Rationale and design of the Transendocardial Injection of Autologous Human Cells (bone marrow or mesenchymal) in Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction (TAC-HFT) trial: A randomized, double-blind, placebo-controlled study of safety and efficacy. Am Heart J. 2011 Mar;161(3):487-93. doi: 10.1016/j.ahj.2010.11.024.
PubMed 21392602
Hare JM, DiFede DL, Rieger AC, Florea V, Landin AM, El-Khorazaty J, Khan A, Mushtaq M, Lowery MH, Byrnes JJ, Hendel RC, Cohen MG, Alfonso CE, Valasaki K, Pujol MV, Golpanian S, Ghersin E, Fishman JE, Pattany P, Gomes SA, Delgado C, Miki R, Abuzeid F, Vidro-Casiano M, Premer C, Medina A, Porras V, Hatzistergos KE, Anderson E, Mendizabal A, Mitrani R, Heldman AW. Randomized Comparison of Allogeneic Versus Autologous Mesenchymal Stem Cells for Nonischemic Dilated Cardiomyopathy: POSEIDON-DCM Trial. J Am Coll Cardiol. 2017 Feb 7;69(5):526-537. doi: 10.1016/j.jacc.2016.11.009. Epub 2016 Nov 14.
PubMed 27856208
Premer C, Wanschel A, Porras V, Balkan W, Legendre-Hyldig T, Saltzman RG, Dong C, Schulman IH, Hare JM. Mesenchymal Stem Cell Secretion of SDF-1alpha Modulates Endothelial Function in Dilated Cardiomyopathy. Front Physiol. 2019 Sep 24;10:1182. doi: 10.3389/fphys.2019.01182. eCollection 2019.
PubMed 31616309
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
Mushtaq M, DiFede DL, Golpanian S, Khan A, Gomes SA, Mendizabal A, Heldman AW, Hare JM. Rationale and design of the Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis in Dilated Cardiomyopathy (the POSEIDON-DCM study): a phase I/II, randomized pilot study of the comparative safety and efficacy of transendocardial injection of autologous mesenchymal stem cell vs. allogeneic mesenchymal stem cells in patients with non-ischemic dilated cardiomyopathy. J Cardiovasc Transl Res. 2014 Dec;7(9):769-80. doi: 10.1007/s12265-014-9594-0. Epub 2014 Oct 30.
PubMed 25354998

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy
Non-ischemic Dilated Cardiomyopathy
Recruiting
Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead
Idiopathic Cardiomyopathy, Left Ventricular (LV) Systolic Dysfunction
Active, not recruitingPhase 1
Treatment of Non-ischemic Cardiomyopathies by Intravenous Extracellular Vesicles of Cardiovascular Progenitor Cells
Heart Failure With Reduced Ejection Fraction
Recruiting
High Fat Diet for Cardiac Metabolic Reprogramming
Non-ischemic Dilated Cardiomyopathy, Heart Failure With Reduced Ejection Fraction
Enrolling by invitation
Mainstreaming Genetic Testing for Non-Ischemic Cardiomyopathy in Western Canada
Nonischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)

All Non-ischemic Dilated Cardiomyopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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 Non-ischemic Dilated Cardiomyopathy.
ClinicalTrials.gov ID: NCT01392625
Acronym / sponsor ID: PoseidonDCM / 20100968
Conditions: Non-ischemic Dilated Cardiomyopathy
Keywords: Non ischemic dilated cardiomyopathy, Dilated cardiomyopathy, Heart failure, Cardiac Stem Cell Transplantation, Stem Cells
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Joshua M HareUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 19 May 2011 (actual)
Primary completion: 28 Aug 2016 (actual)
Study completion: 28 Aug 2017 (actual)
First posted: 12 Jul 2011 (estimated)
Results: Posted 15 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Patients will be randomized in a 1:1 ratio to one of the two groups.

Treatment Strategies: Autologous hMSCs vs. Allogeneic hMSCs. The Study Team will record and maintain a detailed record of injection locations.

If a patient is randomized to Groups 1 (Auto-hMSCs) and the Auto-hMSCs do not expand to the required dose of 1 X 108 cells, each injection will contain the maximum number of cells available.

The injections will be administered transendocardially during cardiac catheterization using the Biosense Webster MyoStar NOGA Catheter System.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Autologous hMSCs	Active comparator	Biological: Autologous hMSCsGroup 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Allogeneic hMSCs	Active comparator	Biological: Allogeneic hMSCsGroup 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Who may qualify

Ages: 18 to 95 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
Autologous hMSCsAlso: Biosense Webster MyoStar NOGA Injection Catheter System.Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection: Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.	Biological	Autologous hMSCs
Allogeneic hMSCsAlso: Biosense Webster MyoStar NOGA Injection Catheter System.Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection: Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.	Biological	Allogeneic hMSCs

Primary outcome

Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs)
Time frame: One month post-catheterization
Incidence of TE-SAEs is defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise), or any other potential late effects detected and corroborated by clinical presentation, laboratory investigations, image analysis and when necessary with biopsy from suspected target sites in the body.

5 secondary outcomes

Measurement of Changes in Peak VO2
Time frame: Baseline, 6 month and 12 month
Measurement of Changes in 6 Minute Walk
Time frame: Baseline, 6 month and 12 month
Measurement of Changes in Global Ejection Fraction
Time frame: Baseline, 6 month and 12 month
Measurement of Changes in New York Heart Association (NYHA)
Time frame: Baseline, 6 month and 12 month
Measurement of Changes in Minnesota Living With Heart Failure (MLHF) Questionnaire
Time frame: Baseline, 6 month and 12 month

Results and safety

Results posted to the registry on 15 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Autologous hMSCs	18	16
Allogeneic hMSCs	19	18

Primary outcome: Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs)

Time frame: One month post-catheterization. Count of participants. Unit: Participants

Measure	Autologous hMSCs n = 16	Allogeneic hMSCs n = 18
Upper respiratory tract infection	1	0
Ventricular tachycardia	0	1
Device Pacing issue	0	1

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: These AE's were collected over a period of 1 year from the subject signing the consent form.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Autologous hMSCs	6 of 18 (33.3%)	4 of 18 (22.2%)	2 of 18
Allogeneic hMSCs	6 of 19 (31.6%)	7 of 19 (36.8%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21415390Williams AR, Trachtenberg B, Velazquez DL, McNiece I, Altman P, Rouy D, Mendizabal AM, Pattany PM, Lopera GA, Fishman J, Zambrano JP, Heldman AW, Hare JM. Intramyocardial stem cell injection in patients with ischemic cardiomyopathy: functional recovery and reverse remodeling. Circ Res. 2011 Apr 1;108(7):792-6. doi: 10.1161/CIRCRESAHA.111.242610. Epub 2011 Mar 17.
Background: PubMed 21392602Trachtenberg B, Velazquez DL, Williams AR, McNiece I, Fishman J, Nguyen K, Rouy D, Altman P, Schwarz R, Mendizabal A, Oskouei B, Byrnes J, Soto V, Tracy M, Zambrano JP, Heldman AW, Hare JM. Rationale and design of the Transendocardial Injection of Autologous Human Cells (bone marrow or mesenchymal) in Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction (TAC-HFT) trial: A randomized, double-blind, placebo-controlled study of safety and efficacy. Am Heart J. 2011 Mar;161(3):487-93. doi: 10.1016/j.ahj.2010.11.024.
Background: PubMed 27856208Hare JM, DiFede DL, Rieger AC, Florea V, Landin AM, El-Khorazaty J, Khan A, Mushtaq M, Lowery MH, Byrnes JJ, Hendel RC, Cohen MG, Alfonso CE, Valasaki K, Pujol MV, Golpanian S, Ghersin E, Fishman JE, Pattany P, Gomes SA, Delgado C, Miki R, Abuzeid F, Vidro-Casiano M, Premer C, Medina A, Porras V, Hatzistergos KE, Anderson E, Mendizabal A, Mitrani R, Heldman AW. Randomized Comparison of Allogeneic Versus Autologous Mesenchymal Stem Cells for Nonischemic Dilated Cardiomyopathy: POSEIDON-DCM Trial. J Am Coll Cardiol. 2017 Feb 7;69(5):526-537. doi: 10.1016/j.jacc.2016.11.009. Epub 2016 Nov 14.
Derived from this study: PubMed 31616309Premer C, Wanschel A, Porras V, Balkan W, Legendre-Hyldig T, Saltzman RG, Dong C, Schulman IH, Hare JM. Mesenchymal Stem Cell Secretion of SDF-1alpha Modulates Endothelial Function in Dilated Cardiomyopathy. Front Physiol. 2019 Sep 24;10:1182. doi: 10.3389/fphys.2019.01182. eCollection 2019.
Derived from this study: PubMed 30005555Tompkins 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.
Derived from this study: PubMed 25354998Mushtaq M, DiFede DL, Golpanian S, Khan A, Gomes SA, Mendizabal A, Heldman AW, Hare JM. Rationale and design of the Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis in Dilated Cardiomyopathy (the POSEIDON-DCM study): a phase I/II, randomized pilot study of the comparative safety and efficacy of transendocardial injection of autologous mesenchymal stem cell vs. allogeneic mesenchymal stem cells in patients with non-ischemic dilated cardiomyopathy. J Cardiovasc Transl Res. 2014 Dec;7(9):769-80. doi: 10.1007/s12265-014-9594-0. Epub 2014 Oct 30.
Interdisciplinary Stem Cell Institute University of MiamiLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Non-ischemic Dilated Cardiomyopathy

Active, not recruitingPhase 2
Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy
Non-ischemic Dilated Cardiomyopathy
Recruiting
Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead
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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.

Joshua M Hare, MD principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Autologous hMSCs and Allogeneic hMSCs in people with Non-ischemic Dilated Cardiomyopathy, run by Joshua M Hare 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?

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 15 Feb 2018. 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. 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 15 Feb 2018). 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 Any Treatment-emergent Serious Adverse Events (TE-SAEs) (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 NCT01392625, which also lists 6 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 15 Feb 2018.