SINGaporean Program Performed With an eXPANsion Medical Device (SingXpand)

NCT04198883 | Withdrawn Phase 1 DMC FDA Device

• 1 other identifier: CellProthera
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Attack

Outcome Measures

Primary Outcomes (1)

• MACE,SAE and AE

  Description, incidence and assessment of MACE (Major Adverse Cardiac Events), SAE and AE .

  1 year

Secondary Outcomes (1)

• Change of Cardiac function assessed by cMRI

  1 year

Study Arms (1)

Protheracytes

EXPERIMENTAL

Single arm study : Stem cells injection called Protheracytes

Combination Product: Protheracytes

Interventions

Protheracytes COMBINATION_PRODUCT

Intramyocardiac (LV) injection of stem cells with a dedicated catheter

Also known as: Biocardia Helix catheter

Protheracytes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Anterior wall AMI
• PTCA and stent(s) implantation (=Day 0)
• 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
• Age must be ≥ 21 and ≤ 80 years
• 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.
• Having previously signed a written informed consent prior to any study-specific procedures.
• 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
• LVEF remaining ≤ 45% assessed by cMRI
• Identification of anterior akinetic segment(s) of interest assessed by cMRI
• Identification of non-viability of anterior segment(s) of interest assessed by cMRI

You may not qualify if:

• Previous and known symptomatic CHF, from class II to IV (included)
• History of CABG (Coronary Artery Bypass Surgery) surgery
• History of former significant mitral valve replacement surgery or heart transplantation.
• Severe valve disease: mitral, aortic stenosis / insufficiency.
• Diagnosis of non-ischemic dilated cardiomyopathy due to valvular dysfunction, mitral regurgitation, tachycardia, or myocarditis
• Aortic stenosis as determined as valve area less than 1 cm2 that prohibits catheter access to LV
• Presence of a prosthetic / mechanical aortic or mitral valve or heart constrictive device.
• Documented presence of a known LV thrombus
• Sepsis
• Endocarditis
• Infectious pericarditis
• Pericardial tamponade
• Left ventricular aneurysm, collagen tissue disease
• Severe peripheral vascular disease precluding femoral artery access as determined at the time of original catheterization.
• Pacemaker, implantable cardiac defibrillator, and intra-cerebral aneurysm clips.

Sponsors & Collaborators

• CellProthera: lead

Study Sites (1)

NHCS

Singapore, 169609, Singapore

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Frederic Flandrin

  CellProthera

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: the design : pilot, single-arm, open-labelled study

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: December 13, 2019
• Study Start: November 27, 2018
• Primary Completion: June 30, 2020
• Study Completion: July 31, 2021
• Last Updated: June 10, 2022

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)