SINGaporean Program Performed With an eXPANsion Medical Device (SingXpand) (SingXpand)

SINGaporean Program Performed With an eXPANsion Medical Device

The purpose of the pilot study is to evaluate the safety and the individual efficacy of the use of ProtheraCytes® in patients with acute myocardial infarction and decreased ejection fraction. CD34+ cells will be re-injected using a dedicated catheter pushed through the femoral artery up to the left ventricle, thus avoiding open chest surgery.

Study Overview

• Status: Withdrawn
• Conditions: Heart Attack
• Intervention / Treatment: Combination product: Protheracytes

Detailed Description

Primary Objective : The objective is to establish the safety of the interventional procedure beginning at the first G-CSF administration to 6 months after the injection of autologous expanded CD34+ stem cells (ProtheraCytes®) in AMI patients with a LVEF≤45% after PTCA and stent(s) implantation.

Secondary Objective : The objective is to establish the individual efficacy of the interventional procedure beginning at the first G-CSF administration to 6 months after the injection of autologous expanded CD34+ stem cells (ProtheraCytes®) in AMI patients with a LVEF≤45% after PTCA and stent(s) implantation.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169609
    • NHCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. De Novo AMI with or without ST segment elevation and with a detection of rise and/or fall of cardiac biomarker values (troponin) with at least one value above the 99th percentile of the upper reference limit.
2. Anterior wall AMI
3. PTCA and stent(s) implantation (=Day 0)
4. LVEF ≤ 45% after stent(s) implantation: Combination of a LVEF ≤ 45 % and of anterior akinetic segment(s) - by echography at Day 2 ± 1 after stent(s) implantations
5. Age must be ≥ 21 and ≤ 80 years
6. Men and Non-pregnant non-lactating women who take efficacious contraceptive measures such as oral contraceptive medications or efficacious and permanent intra-uterine device (drug eluted or not) (IUD) or subcutaneous permanent contraceptive implants or menopaused women (at least a 2 years confirmed menopause) or surgically sterilized women.
7. Having previously signed a written informed consent prior to any study-specific procedures.

8. LVEF remaining ≤ 45% assessed by a 2nd echography at Day 8 (± 2) after stent(s) implantation.

   If these criteria have been validated, then the following assessments will be carried out only after the 2nd echography

9. LVEF remaining ≤ 45% assessed by cMRI
10. Identification of anterior akinetic segment(s) of interest assessed by cMRI
11. Identification of non-viability of anterior segment(s) of interest assessed by cMRI

Exclusion Criteria:

1. Previous and known symptomatic CHF, from class II to IV (included)
2. History of CABG (Coronary Artery Bypass Surgery) surgery
3. History of former significant mitral valve replacement surgery or heart transplantation.
4. Severe valve disease: mitral, aortic stenosis / insufficiency.
5. Diagnosis of non-ischemic dilated cardiomyopathy due to valvular dysfunction, mitral regurgitation, tachycardia, or myocarditis
6. Aortic stenosis as determined as valve area less than 1 cm2 that prohibits catheter access to LV
7. Presence of a prosthetic / mechanical aortic or mitral valve or heart constrictive device.
8. Documented presence of a known LV thrombus
9. Sepsis
10. Endocarditis
11. Infectious pericarditis
12. Pericardial tamponade
13. Left ventricular aneurysm, collagen tissue disease
14. Severe peripheral vascular disease precluding femoral artery access as determined at the time of original catheterization.
15. Pacemaker, implantable cardiac defibrillator, and intra-cerebral aneurysm clips.
16. History of metallic foreign body in their eye
17. Former or current aortic dissection
18. Inadequate bone marrow function: Haemoglobin < 10 g/dL and Platelet count < 100 x 109 / L
19. Previous G-CSF or other Hematopoietic Growth Factor administrations.
20. Blood transfusion(s) within the previous 4 weeks (to exclude potential non-autologous ACPs (Angiogenic Cells Precursors) in the harvested blood).
21. Hepatic failure or history of liver cirrhosis or hepatic severe impairment.
22. Constitutional or acquired coagulopathy
23. Treated chronic renal failure, or haemodialysis or renal severe impairment (creatinine clearance < 30ml/min).
24. Prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer or previous cancer in complete response without any treatment in the last 5 years.
25. History of prior mediastinal radiation exposure
26. Serious underlying medical conditions at the investigator's discretion, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, active autoimmune disease, Amyotrophic Lateral Sclerosis, Systemic Lupus, Multiple Sclerosis).
27. Chronic immunomodulatory or cytotoxic drug treatment intake.
28. Active bleeding or major surgery within 1 month.
29. Human immunodeficiency HIV1-2, HTLV1, HTLV2
30. History or current Hepatitis B (prior vaccination accepted)
31. History or current Hepatitis C
32. Syphilis
33. Chronic Obstructive Pulmonary Disease.
34. Active participation in any other clinical trials
35. Current or recent treatment (within the 60 days period before PTCA and stent(s) implantation) with another investigational drug or procedure.
36. Any other co-existing conditions that will preclude participation in the study or compromise ability to give informed consent.
37. Requirement of i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump) initiated 24 hours before cMRI.
38. Splenomegaly
39. Phenylketonuria
40. History of iron-Dextran allergy
41. History of murin protein allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Protheracytes; Single arm study : Stem cells injection called Protheracytes	Combination product: Protheracytes; Intramyocardiac (LV) injection of stem cells with a dedicated catheter; Other Names: Biocardia Helix catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE,SAE and AE	Description, incidence and assessment of MACE (Major Adverse Cardiac Events), SAE and AE .	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Cardiac function assessed by cMRI	Assessment of individual change of cardiac function via cardiac MRI performed at screening, and 3, 6 & 12 months after ProtheraCytes® administration.; Assessment of Cardiac Event Free Survival.; Median Time assessment between treatment procedure onset and cardiac relapse.	1 year

Collaborators and Investigators

• Sponsor: CellProthera
• Investigators: Study Director: Frederic Flandrin, CellProthera

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 27, 2018
• Primary Completion (ANTICIPATED): June 30, 2020
• Study Completion (ANTICIPATED): July 31, 2021

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (ACTUAL): December 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Myocardial Infarction
• Other Study ID Numbers: CellProthera

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes