NCT04198883

SINGaporean Program Performed With an eXPANsion Medical Device (SingXpand)

SINGaporean Program Performed With an eXPANsion Medical Device

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: CellProthera · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Heart Attack

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Protheracytes	Intramyocardiac (LV) injection of stem cells with a dedicated catheter

Timeline

• Start date: 2018-11-27
• Primary completion: 2020-06-30
• Completion: 2021-07-31
• First posted: 2019-12-13
• Last updated: 2022-06-10

Locations

1 site across 1 country: Singapore

Regulatory

• FDA-regulated device study