Intravenous MSC Therapy on Ischemia-Reperfusion Injury in Patients With Myocardial Infarction

NCT03533153 | Unknown Phase 1

• 1 other identifier: MSC-NanjingUMS
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators scheduled to assess the value of intravenous injection of WJ-MSC in patients with ST-segment elevation myocardial infarction (STEMI).

Conditions

Myocardial Infarction

Keywords

MSC

Outcome Measures

Primary Outcomes (1)

• IS

  The primary endpoint is based on patients' myocardial infarction size (IS) as a result of CMR examination. The detection is recorded in the follow up at Month 3.

  at Month 3 after treatment.

Secondary Outcomes (8)

• MACCE

  within 1 year after PCI.

• MVO and Hemorrhage

  at Day 4 to Day 7 after PCI.

• CMR Markers of Myocardial and Microvascular Damage

  at Month 3 after PCI.

• CK-MB and Troponin

  at baseline and at Hour 6, Hour 12, Hour 24 and Hour 48 after PCI.

• Echocardiographic Changes

  at Hour 6, Week 1, Month 1, Month 6 and Year 1 after PCI.

Study Arms (2)

WJ-MSC cells implantation group

EXPERIMENTAL

MSC cells (allogeneic transplantation from WJ-MSC primary cells); the frequency: for one time within12h after emergency coronary artery revascularization; dose levels: 1X10\^8; method of administration: intravenous injection. Other kinds of treatment are in accordance with the treatment guidelines for MI patients, listed in the column "Conventional drug therapy".

Biological: WJ-MSC cells implantation; Drug: Conventional drug therapy

CTSTMD PBS without WJ-MSC group

PLACEBO COMPARATOR

Saline only was injected in the control group. The frequency: for one time 2-12h after emergency coronary artery revascularization. Dose levels: the same dosage given to MSC group. Method of administration: intravenous injection. Other kinds of treatment are in accordance with the treatment guidelines for MI patients, listed in the column "Conventional drug therapy".

Drug: CTSTMD PBS without WJ-MSC; Drug: Conventional drug therapy

Interventions

WJ-MSC cells implantation BIOLOGICAL

Laboratory of Stem Cell of Drum Tower Hospital, Nanjing University Medical School, is able to provide types of Good Manufacture Practice (GMP) level stem cells and stem cell-based medicinal products. Clinical-grade WJ-MSC primary cells are cultured to 4\~ 8 passages, and the surface markers (CD90+, CD105+, CD45-, CD31-, CD117-) are identified by flow cytometry. WJ-MSC cells are trypsinized and resuspended in the wash buffer of CTSTMD PBS (+Ca2+, +Mg2+). Within 2 hours after enzyme digestion, WJ-MSC cells are shipped to coronary care unit (CCU) and injected into the body.

Also known as: WJ-MSC

WJ-MSC cells implantation group

CTSTMD PBS without WJ-MSC DRUG

For Case-control study only.

Also known as: CTSTMD PBS

CTSTMD PBS without WJ-MSC group

Conventional drug therapy DRUG

All patients undergo guideline-recommended treatment for STEMI, including aspirin (loading dose of 300mg before maintenance dose of 100 mg/d), clopidogrel (loading dose of 300mg before maintenance dose of 75 mg/d) or Ticagrelor (loading dose of 300mg before maintenance dose of 90 mg/d), angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB), β-receptor blockers, statins and nitrate esters.

Also known as: Conventional

CTSTMD PBS without WJ-MSC group; WJ-MSC cells implantation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75;
• First performance of anterior acute ST-segment elevation myocardial infarction (STEMI), Killip grade 2 or below on admission;
• Completing emergency percutaneous coronary intervention within 12h, with TIMI flow grade 0 or 1 (before stent implantation) and 3 (after stent implantation);
• LVEF in echocardiography is 45% or below primary PCI.

You may not qualify if:

• Medical history of Q wave myocardial infarction, significant valve disease, pericarditis, pericardial tamponade, myocardiopathy, chronic heart failure or cardio embolism;
• Non ST-segment elevation myocardial infarction;
• Chronic occlusion in LCX or RCA besides LAD;
• Diagnosed with severe coronary artery disease but not yet causing a loss of heart function;
• Hemodynamic disorders, shock or respiratory failure on admission;
• Atrial fibrillation with warfarin treatment only or at high risk of bleeding;
• Constant tachycardia, malignant arrhythmia, complete atrioventricular block, new-onset complete left bundle branch block (LBBB) or pacemaker implantation;
• Mechanical complications of acute myocardial infarction (interventricular septal defect, rupture of papillary muscle, etc.) or huge left ventricular aneurysm could only be corrected through surgical procedures;
• Chronic pulmonary heart disease (COPD, bronchial asthma, chronic bronchitis, emphysema or pulmonary heart disease), autoimmune disease or patients on immunosuppressive therapy;
• Acute infective disease;
• Hepatitis B/C virus or HIV;
• Blood system diseases (thrombocytopenia, severe anemia, leukemia, etc.);
• Severe renal insufficiency, with creatinine clearance (CCr) \<33 ml/min or serum creatinine \>133 μmol/L;
• Obvious abnormalities in liver function (ALT and AST 3 times higher than the upper limit of normal value);
• Medical history of cerebral hemorrhage;

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Related Publications (4)

• Ahn JM, Park DW, Lee CW, Chang M, Cavalcante R, Sotomi Y, Onuma Y, Tenekecioglu E, Han M, Lee PH, Kang SJ, Lee SW, Kim YH, Park SW, Serruys PW, Park SJ. Comparison of Stenting Versus Bypass Surgery According to the Completeness of Revascularization in Severe Coronary Artery Disease: Patient-Level Pooled Analysis of the SYNTAX, PRECOMBAT, and BEST Trials. JACC Cardiovasc Interv. 2017 Jul 24;10(14):1415-1424. doi: 10.1016/j.jcin.2017.04.037.

  PMID: 28728654 BACKGROUND

• Symons R, Pontone G, Schwitter J, Francone M, Iglesias JF, Barison A, Zalewski J, de Luca L, Degrauwe S, Claus P, Guglielmo M, Nessler J, Carbone I, Ferro G, Durak M, Magistrelli P, Lo Presti A, Aquaro GD, Eeckhout E, Roguelov C, Andreini D, Vogt P, Guaricci AI, Mushtaq S, Lorenzoni V, Muller O, Desmet W, Agati L, Janssens S, Bogaert J, Masci PG. Long-Term Incremental Prognostic Value of Cardiovascular Magnetic Resonance After ST-Segment Elevation Myocardial Infarction: A Study of the Collaborative Registry on CMR in STEMI. JACC Cardiovasc Imaging. 2018 Jun;11(6):813-825. doi: 10.1016/j.jcmg.2017.05.023. Epub 2017 Aug 16.

  PMID: 28823746 BACKGROUND

• Cuculi F, Dall'Armellina E, Manlhiot C, De Caterina AR, Colyer S, Ferreira V, Morovat A, Prendergast BD, Forfar JC, Alp NJ, Choudhury RP, Neubauer S, Channon KM, Banning AP, Kharbanda RK. Early change in invasive measures of microvascular function can predict myocardial recovery following PCI for ST-elevation myocardial infarction. Eur Heart J. 2014 Aug 1;35(29):1971-80. doi: 10.1093/eurheartj/eht434. Epub 2013 Oct 17.

  PMID: 24135835 BACKGROUND

• Robbers LF, Eerenberg ES, Teunissen PF, Jansen MF, Hollander MR, Horrevoets AJ, Knaapen P, Nijveldt R, Heymans MW, Levi MM, van Rossum AC, Niessen HW, Marcu CB, Beek AM, van Royen N. Magnetic resonance imaging-defined areas of microvascular obstruction after acute myocardial infarction represent microvascular destruction and haemorrhage. Eur Heart J. 2013 Aug;34(30):2346-53. doi: 10.1093/eurheartj/eht100. Epub 2013 Apr 17.

  PMID: 23594591 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• BIAO XU, Ph.D.

  Drum Tower Hospital, Nanjing University Medical School

  STUDY CHAIR

Central Study Contacts

ZILUN WEI, PGT

CONTACT

86-18066045583; ljdwdth@outlook.com

JUN XIE, Ph.D.

CONTACT

86-13913859989; darcy_pann@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: May 23, 2018
• Study Start: March 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2025
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share