NCT04011059: scorem-cells

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

Status unknown Phase 1, PHASE2 Last updated 9 July 2019

What this trial tests

Phase 1, PHASE2 trial testing Wharton's jelly-derived mesenchymal cells in Cardiovascular Diseases in 40 participants. Status unknown.

Timeline

2 July 2019

Primary endpoint
30 January 2022

30 June 2023

Quick facts

Lead sponsor	Hospital San Vicente Fundación
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	2 July 2019
Primary completion	30 January 2022
Estimated completion	30 June 2023
Sites	1 location across Colombia

Drugs / interventions tested

• Wharton's jelly-derived mesenchymal cells — full drug profile →

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Heart Failure — all drugs for Heart Failure →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Mesenchymal Stem Cell Transplantation — all drugs for Mesenchymal Stem Cell Transplantation →

Sponsor

Hospital San Vicente Fundación

Who can join

Adults 30 to 75, any sex, with Cardiovascular Diseases or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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%.

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Next generation of heart regenerative therapies: progress and promise of cardiac tissue engineering.
   Tenreiro MF, Louro AF, Alves PM, Serra M. · · 2021 · cited 98× · PMID 34075050 · DOI 10.1038/s41536-021-00140-4
2. Human Wharton's Jelly-Cellular Specificity, Stemness Potency, Animal Models, and Current Application in Human Clinical Trials.
   Stefańska K, Ożegowska K, Hutchings G, Popis M, et al · · 2020 · cited 52× · PMID 32290584 · DOI 10.3390/jcm9041102
3. Mesenchymal Stem Cell (MSCs) Therapy for Ischemic Heart Disease: A Promising Frontier.
   Poomani MS, Mariappan I, Perumal R, Regurajan R, et al · · 2022 · cited 37× · PMID 35342702 · DOI 10.5334/gh.1098
4. The application of umbilical cord-derived MSCs in cardiovascular diseases.
   Chen Y, Shen H, Ding Y, Yu Y, et al · · 2021 · cited 36× · PMID 34378345 · DOI 10.1111/jcmm.16830
5. Mesenchymal Stem Cells Therapies on Fibrotic Heart Diseases.
   Gubert F, da Silva JS, Vasques JF, de Jesus Gonçalves RG, et al · · 2021 · cited 29× · PMID 34299066 · DOI 10.3390/ijms22147447
6. Umbilical Cord Blood Transplantation: Connecting Its Origin to Its Future.
   Sanchez-Petitto G, Rezvani K, Daher M, Rafei H, et al · · 2023 · cited 26× · PMID 36779789 · DOI 10.1093/stcltm/szac086
7. Wharton's jelly mesenchymal stem cells: Future regenerative medicine for clinical applications in mitigation of radiation injury.
   Sharma P, Maurya DK. · · 2024 · cited 12× · PMID 39086560 · DOI 10.4252/wjsc.v16.i7.742
8. The role of the extracellular matrix in cardiac regeneration.
   Wang X, Yu S, Xie L, Xiang M, et al · · 2025 · cited 7× · PMID 39834404 · DOI 10.1016/j.heliyon.2024.e41157