- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04011059
Randomized Study of Coronary Revascularization Surgery With Injection of WJ-MSCs and Placement of an Epicardial Extracellular Matrix (scorem-cells)
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%.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Luis H Atehortua Lopez, MSc
- Phone Number: 3138 +57 4441333
- Email: horacio.atehortua@sanvicentefundacion.com
Study Contact Backup
- Name: Segio Estrada Mira, MSc
- Phone Number: +57 3014297223
- Email: sergio.estrada@udea.edu.co
Study Locations
-
-
Antioquia
-
Medellín, Antioquia, Colombia
- Hospital San Vicente Fundación
-
Contact:
- Luis H Atehortua, MSc
- Phone Number: 3138 +57 4441333
- Email: horacio.atehortua@sanvicentefundacion.com
-
Contact:
- Sergio Estrada Mira, MSc
- Phone Number: +57 3014297223
- Email: sergio.estrada@udea.edu.co
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Comparison/control group
Revascularization surgery, placement of an extracellular matrix patch without WJ-MSCs and injection of culture medium without WJ-MSCs will be performed.
|
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.
|
Active Comparator: Experimental group
Revascularization 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Left ventricular ejection fraction (LVEF)
Time Frame: 12 months
|
Percentage of improvement in left ventricular ejection fraction (LVEF) on transthoracic echocardiography and cardiac magnetic resonance imaging (MRI)
|
12 months
|
Final diastolic and systolic volumes
Time Frame: 12 months
|
Percentage of improvement of the final diastolic and systolic volumes on transthoracic echocardiography and cardiac MRI
|
12 months
|
Left ventricule viability
Time Frame: 12 months
|
Effect on viability, defined as a percentage of wall involvement, and improvement in segment-to-segment contractility measured with MRI
|
12 months
|
Ventricular arrhythmias
Time Frame: 12 months
|
Incidence of ventricular arrhythmias defined as nonsustained ventricular tachycardia (NSTV) or high- or low-grade ventricular extrasystoles
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimated functional status
Time Frame: 12 months
|
Recovery of the estimated functional status according to the New York Heart Association (NYHA) classification
|
12 months
|
Change in the median score of Quality of life
Time Frame: 12 months
|
Change in the median score for quality of life of the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
|
12 months
|
Delayed enhancement of the left ventricle
Time Frame: 12 months
|
Changes in the delayed enhancement of the left ventricle on MRI, defined as percentage of the wall thickness involved when adding each segment visually
|
12 months
|
Improvement in the 6-minute walk test
Time Frame: 12 months
|
Improvement in the 6-minute walk test, defined as the percentage of change of the distance traveled
|
12 months
|
Mortality at 3 and 12 months due to cardiovascular causes
Time Frame: 12 months
|
Mortality at 3 and 12 months due to cardiovascular causes
|
12 months
|
Mortality at 3 and 12 months due to all causes
Time Frame: 12 months
|
Mortality at 3 and 12 months due to all causes
|
12 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
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- 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.
- 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.
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- 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.
- 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.
- Barminko J, Gray A, Maguire T, Schloss R, Yarmush ML. Mesenchymal Stem Cell Therapy. Mesenchymal Stem Cell Therapy. 405-421, 2013
- Wolfe M, Pochampally R, Swaney W, Reger RL. Isolation and culture of bone marrow-derived human multipotent stromal cells (hMSCs). Methods Mol Biol. 2008;449:3-25. doi: 10.1007/978-1-60327-169-1_1.
- Tanavde V, Vemuri MC. Mesenchymal stromal cells in the clinic: What do the clinical trials say? In: Mesenchymal Stem Cell Therapy. 423-33, 2013
- Wang HS, Hung SC, Peng ST, Huang CC, Wei HM, Guo YJ, Fu YS, Lai MC, Chen CC. Mesenchymal stem cells in the Wharton's jelly of the human umbilical cord. Stem Cells. 2004;22(7):1330-7. doi: 10.1634/stemcells.2004-0013.
- Weiss ML, Anderson C, Medicetty S, Seshareddy KB, Weiss RJ, VanderWerff I, Troyer D, McIntosh KR. Immune properties of human umbilical cord Wharton's jelly-derived cells. Stem Cells. 2008 Nov;26(11):2865-74. doi: 10.1634/stemcells.2007-1028. Epub 2008 Aug 14.
- Bensaid W, Triffitt JT, Blanchat C, Oudina K, Sedel L, Petite H. A biodegradable fibrin scaffold for mesenchymal stem cell transplantation. Biomaterials. 2003 Jun;24(14):2497-502. doi: 10.1016/s0142-9612(02)00618-x.
- Baraniak PR, McDevitt TC. Scaffold-free culture of mesenchymal stem cell spheroids in suspension preserves multilineage potential. Cell Tissue Res. 2012 Mar;347(3):701-11. doi: 10.1007/s00441-011-1215-5. Epub 2011 Aug 11.
- Timmers L, Lim SK, Hoefer IE, Arslan F, Lai RC, van Oorschot AA, Goumans MJ, Strijder C, Sze SK, Choo A, Piek JJ, Doevendans PA, Pasterkamp G, de Kleijn DP. Human mesenchymal stem cell-conditioned medium improves cardiac function following myocardial infarction. Stem Cell Res. 2011 May;6(3):206-14. doi: 10.1016/j.scr.2011.01.001. Epub 2011 Jan 28.
- Chong JJ, Chandrakanthan V, Xaymardan M, Asli NS, Li J, Ahmed I, Heffernan C, Menon MK, Scarlett CJ, Rashidianfar A, Biben C, Zoellner H, Colvin EK, Pimanda JE, Biankin AV, Zhou B, Pu WT, Prall OW, Harvey RP. Adult cardiac-resident MSC-like stem cells with a proepicardial origin. Cell Stem Cell. 2011 Dec 2;9(6):527-40. doi: 10.1016/j.stem.2011.10.002.
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- Beltrami AP, Urbanek K, Kajstura J, Yan SM, Finato N, Bussani R, Nadal-Ginard B, Silvestri F, Leri A, Beltrami CA, Anversa P. Evidence that human cardiac myocytes divide after myocardial infarction. N Engl J Med. 2001 Jun 7;344(23):1750-7. doi: 10.1056/NEJM200106073442303.
- Ghostine S, Carrion C, Souza LC, Richard P, Bruneval P, Vilquin JT, Pouzet B, Schwartz K, Menasche P, Hagege AA. Long-term efficacy of myoblast transplantation on regional structure and function after myocardial infarction. Circulation. 2002 Sep 24;106(12 Suppl 1):I131-6.
- Brooke G, Cook M, Blair C, Han R, Heazlewood C, Jones B, Kambouris M, Kollar K, McTaggart S, Pelekanos R, Rice A, Rossetti T, Atkinson K. Therapeutic applications of mesenchymal stromal cells. Semin Cell Dev Biol. 2007 Dec;18(6):846-58. doi: 10.1016/j.semcdb.2007.09.012. Epub 2007 Sep 18.
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- Nimsanor N, Phetfong J, Plabplueng C, Jangpatarapongsa K, Prachayasittikul V, Supokawej A. Inhibitory effect of oxidative damage on cardiomyocyte differentiation from Wharton's jelly-derived mesenchymal stem cells. Exp Ther Med. 2017 Dec;14(6):5329-5338. doi: 10.3892/etm.2017.5249. Epub 2017 Oct 2.
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Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (NavyGHB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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