AzTrials
AzTrials

Cardiovascular DiseasesPhase 1/2scorem-cellsNCT04011059

Randomized Study of Coronary Revascularization Surgery With Injection of WJ-MSCs and Placement of an Epicardial Extracellular Matrix

A Phase 1/2 study testing Wharton's jelly-derived mesenchymal cells in people with Cardiovascular Diseases and Heart Failure, run by Hospital San Vicente Fundación at 1 site in Colombia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Ischemic heart disease is one of the most important causes of mortality and morbidity in the Western world and is a public health problem. Among ischemic heart diseases, myocardial infarction has specific significance because the cardiac muscle does not have sufficient and adequate capacity to regenerate; therefore… Read more about this study

Who is it for?
Ages 30 to 75 years
What is being tested?
Wharton's jelly-derived mesenchymal cells
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteColombia
Study dates
2 Jul 2019to 30 Jun 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

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 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a diagnosis of coronary disease, performed by coronary angiography, requiring conventional coronary revascularization surgery
  • History of myocardial infarction; evidence of akinesia or regional dyskinesia more than 1 week old
  • Ejection fraction less than 40%
  • Age between 30 and 75 years
  • Negative serology for HIV, hepatitis B virus (HBV), and hepatitis C virus HCV
  • Negative pregnancy test for women of childbearing age
  • Patients who sign the informed consent complying with all of the provisions of current regulations in Colombia

Who cannot join

  • History of myocardial infarction with ST-segment elevation within 2 weeks prior to surgery
  • History of myocardial infarction without ST-segment elevation within the previous week (the decision to include these patients within the first week after suffering a non-ST elevation infarction is at the discretion of the research team)
  • Previous history of tachycardia or ventricular fibrillation
  • History of active neoplasia or previous chemotherapy treatment
  • Severe or uncontrolled concomitant disease (i.e., poorly controlled chronic kidney or liver failure)
  • Patients who, due to their place of residence, mental health or social situation, have difficulty meeting the conditions of the protocol
Show all 10Show fewer
  • Women who are pregnant or breast-feeding
  • Patients or legal representatives withdrawing informed consent at any time during the study.
  • Previous history of heart transplant
  • Patients with functional organ impairment: liver function: total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase greater than 2 times the upper reference limit; kidney function: serum creatinine > 1.5 mg/dl or creatinine clearance < 60 ml/min.

Trial locations and contacts

1 site in 1 country.

Luis H Atehortua Lopez, MSc contact

+57 4441333 ext. 3138

horacio.atehortua@sanvicentefundacion.com

Segio Estrada Mira, MSc contact

+57 3014297223

sergio.estrada@udea.edu.co

Colombia1 site

  • Hospital San Vicente Fundación

    Medellín, Antioquia

    Luis H Atehortua, MSc, +57 4441333 ext. 3138, horacio.atehortua@sanvicentefundacion.com

    Sergio Estrada Mira, MSc, +57 3014297223, sergio.estrada@udea.edu.co

Other trials in Colombia

About this study

Official title: Randomized Study as Proof of Concept of Coronary Revascularization Surgery With Injection of Wharton's Jelly-derived Mesenchymal Cells and Placement of an Epicardial Extracellular Matrix Patch Seeded With WJ-MSCs in Patients With Ischemic Cardiomyopathy

Ischemic heart disease is one of the most important causes of mortality and morbidity in the Western world and is a public health problem. Among ischemic heart diseases, myocardial infarction has specific significance because the cardiac muscle does not have sufficient and adequate capacity to regenerate; therefore, necrosis of a region leads to the formation of a fibrous scar. Infarction can lead to a progressive and irreversible decrease in cardiac function, resulting in heart failure (HF) syndrome, depending on the area affected by this scar, via a ventricular remodeling mechanism.

In recent years, HF has been revealed as a major public health problem due to its incidence and its social, economic and especially human impact, as it represents a serious limitation of the quality of life of individuals. The prevalence of HF in the general population of the United States and the United Kingdom is approximately 1%, and in those older than 75 years, the prevalence varies between 5 and 10%. Regarding its prognosis, recent data from the Framingham Study indicate that at 5 years, the mortality rate of HF is 75% in men and 62% in women; the mean mortality rate of all cancers is 50%.

Read more

The molecular basis of congestive HF is the absence of cardiac cells capable of regenerating the heart muscle. Despite the publication of recent studies suggesting the existence of stem cells capable of regenerating cardiomyocytes destroyed because of myocardial infarction, in humans, the capacity of these cells is insufficient to replace the cells destroyed due to necrosis secondary to ischemia.

In recent years, the accumulation of results derived from preclinical studies has allowed the development of the first clinical trials of the feasibility and safety of cardiac regeneration using cellular therapy. Several studies have shown that t cells exist in adult bone marrow, such as mesenchymal stem cells, hematopoietic stem cells and, more recently, multipotent stem cells (MAPC), with the ability to differentiate into endothelial tissue and cardiac muscle, which can contribute to the regeneration of damaged myocardial tissue and improve cardiac function in animal infarction models. However, cell therapy research has moved rapidly toward the use of more undifferentiated cells rather than hematopoietic lineages, such as mesenchymal cells. These cells can be obtained from different sources, with a tendency toward the use of characterized allogeneic cells, which are immediately available in the potential recipient. Given that this type of therapy has not been rigorously investigated in Latin America, we aim to determine the effect of therapy using Wharton's jelly-derived mesenchymal cells (WJ-MSCs) from the human umbilical cord on neomyogenesis in patients with previous myocardial infarction who are undergoing open revascularization. Our hospital has some experience with regenerative therapy, both in patients with acute myocardial infarction and chronic infarction, with encouraging results that support this new phase of inter-institutional research.

Objective: To evaluate the safety and estimate the effect of coronary revascularization accompanied by intramyocardial injection of WJ-MSCs and the placement of an extracellular matrix patch seeded with WJ-MSCs compared to coronary revascularization accompanied by injection of culture medium without the presence of WJ-MSC and placement of an extracellular matrix patch without seeding with WJ-MSC on global and regional cardiac function, myocardial viability and the incidence of adverse effects determined as ventricular arrhythmias.

Read the detailed description

A randomized clinical trial will be conducted as a proof of concept in 40 patients with previous myocardial infarction and a viable myocardial zone with indications for coronary artery bypass grafts. Twenty patients will be included in each treatment arm over 36 months. One group will undergo revascularization surgery, extracellular matrix patch placement and injection of cell culture medium; the other group will undergo revascularization surgery, extracellular matrix patch placement on the epicardial surface with cultured WJ-MSCs and injection of WJ-MSCs around the infarcted zone.

The allocation of treatments will be defined by block sizes of 2, 4 and 6, randomly determined by a random number generator (ralloc, Stata Co. 8,2). This assignment will only be known by the tissue bank that will deliver the syringes with the solution to be administered and the epicardium patches to the study participants.

Being tested
Wharton's jelly-derived mesenchymal cells
Keywords
Heart Failure, Cardiomyopathies, Coronary Artery Disease, Ischemic Dilated Cardiomyopathy
Medical subject headings
Cardiovascular Diseases, Heart Failure, Coronary Artery Disease, Cardiomyopathies

What participants receive

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

  • Wharton's jelly-derived mesenchymal cellsBiological

    Revascularization surgery, placement of an extracellular matrix patch with WJ-MSCs cultured on the epicardial surface and injection of WJ-MSC around the infarcted zone.

Study groups in NCT04011059
Study groupRoleWhat they receive
Comparison/control groupPlacebo comparatorRevascularization surgery, placement of an extracellular matrix patch without WJ-MSCs and injection of culture medium without WJ-MSCs will be performed.
Receives: Biological: Wharton's jelly-derived mesenchymal cells
Experimental groupActive comparatorRevascularization surgery, placement of an extracellular matrix patch with WJ-MSCs cultured on the epicardial surface and injection of WJ-MSCs around the infarcted zone will be performed.
Receives: Biological: Wharton's jelly-derived mesenchymal cells

What is being measured

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

  1. Left ventricular ejection fraction (LVEF)

    Percentage of improvement in left ventricular ejection fraction (LVEF) on transthoracic echocardiography and cardiac magnetic resonance imaging (MRI)

    Measured: 12 months

  2. Final diastolic and systolic volumes

    Percentage of improvement of the final diastolic and systolic volumes on transthoracic echocardiography and cardiac MRI

    Measured: 12 months

  3. Left ventricule viability

    Effect on viability, defined as a percentage of wall involvement, and improvement in segment-to-segment contractility measured with MRI

    Measured: 12 months

  4. Ventricular arrhythmias

    Incidence of ventricular arrhythmias defined as nonsustained ventricular tachycardia (NSTV) or high- or low-grade ventricular extrasystoles

    Measured: 12 months

Secondary outcomes (6)

  1. Estimated functional status

    Recovery of the estimated functional status according to the New York Heart Association (NYHA) classification

    Measured: 12 months

  2. Change in the median score of Quality of life

    Change in the median score for quality of life of the Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    Measured: 12 months

  3. Delayed enhancement of the left ventricle

    Changes in the delayed enhancement of the left ventricle on MRI, defined as percentage of the wall thickness involved when adding each segment visually

    Measured: 12 months

  4. Improvement in the 6-minute walk test

    Improvement in the 6-minute walk test, defined as the percentage of change of the distance traveled

    Measured: 12 months

  5. Mortality at 3 and 12 months due to cardiovascular causes

    Mortality at 3 and 12 months due to cardiovascular causes

    Measured: 12 months

  6. Mortality at 3 and 12 months due to all causes

    Mortality at 3 and 12 months due to all causes

    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 posted8 Jul 2019
  2. Study start2 Jul 2019 (estimated)
  3. Primary completion30 Jan 2022 (estimated)
  4. Study completion30 Jun 2023 (estimated)

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
Model description
A randomized clinical trial will be conducted as a proof of concept in 40 patients with previous myocardial infarction and a viable myocardial zone with indications for coronary artery bypass grafts. Twenty patients will be included in each treatment arm over 36 months. One group will undergo revascularization surgery, extracellular matrix patch placement and injection of cell culture medium; the other group will undergo revascularization surgery, extracellular matrix patch placement on the epicardial surface with cultured WJ-MSCs and injection of WJ-MSCs around the infarcted zone. The allocation of treatments will be defined by block sizes of 2, 4 and 6, randomly determined by a random number generator (ralloc, Stata Co. 8,2). This assignment will only be known by the tissue bank that will deliver the syringes with the solution to be administered and the epicardium patches to the study participants.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04011059
Sponsor's protocol ID
001
Acronym
scorem-cells
Status last verified
Jul 2019
First submitted
15 Jun 2019
Last updated
9 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fisher SA, Doree C, Mathur A, Martin-Rendon E. Meta-analysis of cell therapy trials for patients with heart failure. Circ Res. 2015 Apr 10;116(8):1361-77. doi: 10.1161/CIRCRESAHA.116.304386. Epub 2015 Jan 28.

    PubMed 25632038

  • Velásquez Ó, Senior JM, Cuéllar F, Velásquez M, García LF, Navas C, et al. Autologous intramyocardial transplant of bone marrow derived stem cells for revascularization in ischemic chronic cardiopathy. Rev Col Cardiol [Internet]. 2005 [cited 2018 May 12];12(12):120-5633.

  • Gómez E. Chapter 2. Introducción, epidemiología de la falla cardiaca e historia de las clínicas de falla cardiaca en Colombia. Rev Colomb Cardiol [Internet]. 2016 Mar 1 [cited 2018 May 12];23:6-12.

  • Cowie MR, Mosterd A, Wood DA, Deckers JW, Poole-Wilson PA, Sutton GC, Grobbee DE. The epidemiology of heart failure. Eur Heart J. 1997 Feb;18(2):208-25. doi: 10.1093/oxfordjournals.eurheartj.a015223. No abstract available.

    PubMed 9043837

  • Trainini JC, Herreros J, Coto E otero, Aguilar JC. La "duda clave" de Torrent Guasp. Cirugía Cardiovasc [Internet]. 2011;18(2):77-81

  • Wang WE, Li L, Xia X, Fu W, Liao Q, Lan C, Yang D, Chen H, Yue R, Zeng C, Zhou L, Zhou B, Duan DD, Chen X, Houser SR, Zeng C. Dedifferentiation, Proliferation, and Redifferentiation of Adult Mammalian Cardiomyocytes After Ischemic Injury. Circulation. 2017 Aug 29;136(9):834-848. doi: 10.1161/CIRCULATIONAHA.116.024307. Epub 2017 Jun 22.

    PubMed 28642276

  • Garbern JC, Lee RT. Cardiac stem cell therapy and the promise of heart regeneration. Cell Stem Cell. 2013 Jun 6;12(6):689-98. doi: 10.1016/j.stem.2013.05.008.

    PubMed 23746978

  • Hong KU, Bolli R. Cardiac stem cell therapy for cardiac repair. Curr Treat Options Cardiovasc Med. 2014 Jul;16(7):324. doi: 10.1007/s11936-014-0324-3.

    PubMed 24903489

  • Zwetsloot PP, Vegh AM, Jansen of Lorkeers SJ, van Hout GP, Currie GL, Sena ES, Gremmels H, Buikema JW, Goumans MJ, Macleod MR, Doevendans PA, Chamuleau SA, Sluijter JP. Cardiac Stem Cell Treatment in Myocardial Infarction: A Systematic Review and Meta-Analysis of Preclinical Studies. Circ Res. 2016 Apr 15;118(8):1223-32. doi: 10.1161/CIRCRESAHA.115.307676. Epub 2016 Feb 17.

    PubMed 26888636

  • Menasche P, Hagege AA, Vilquin JT, Desnos M, Abergel E, Pouzet B, Bel A, Sarateanu S, Scorsin M, Schwartz K, Bruneval P, Benbunan M, Marolleau JP, Duboc D. Autologous skeletal myoblast transplantation for severe postinfarction left ventricular dysfunction. J Am Coll Cardiol. 2003 Apr 2;41(7):1078-83. doi: 10.1016/s0735-1097(03)00092-5.

    PubMed 12679204

  • Patel AN, Geffner L, Vina RF, Saslavsky J, Urschel HC Jr, Kormos R, Benetti F. Surgical treatment for congestive heart failure with autologous adult stem cell transplantation: a prospective randomized study. J Thorac Cardiovasc Surg. 2005 Dec;130(6):1631-8. doi: 10.1016/j.jtcvs.2005.07.056. Epub 2005 Oct 26.

    PubMed 16308009

  • American College of Cardiology. K, Malliaras K, Shen D, Tseliou E, Ionta V, Smith J, et al. Journal of the American College of Cardiology. [Internet]. Vol. 59, Journal of the American College of Cardiology. Elsevier Biomedical; 1983 [cited 2018 May 12]. 256-264

  • Tompkins BA, Balkan W, Winkler J, Gyongyosi M, Goliasch G, Fernandez-Aviles F, Hare JM. Preclinical Studies of Stem Cell Therapy for Heart Disease. Circ Res. 2018 Mar 30;122(7):1006-1020. doi: 10.1161/CIRCRESAHA.117.312486.

    PubMed 29599277

  • Caplan AI. All MSCs are pericytes? Cell Stem Cell. 2008 Sep 11;3(3):229-30. doi: 10.1016/j.stem.2008.08.008. No abstract available.

    PubMed 18786406

  • Caplan AI. Adult mesenchymal stem cells for tissue engineering versus regenerative medicine. J Cell Physiol. 2007 Nov;213(2):341-7. doi: 10.1002/jcp.21200.

    PubMed 17620285

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Wharton's jelly-derived mesenchymal cells in people with Cardiovascular Diseases and Heart Failure, run by Hospital San Vicente Fundación at 1 site in Colombia.

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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 9 Jul 2019. 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 Colombia. 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Luis H Atehortua Lopez, MSc (+57 4441333 ext. 3138, horacio.atehortua@sanvicentefundacion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left ventricular ejection fraction (LVEF) (time frame: 12 months). The study lists 4 primary outcomes in all. 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 NCT04011059, which also lists 40 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 9 Jul 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in