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SINGaporean Program Performed With an eXPANsion Medical Device (SingXpand)

NCT04198883 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2022-06-10

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

Protheracytes

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

Sponsors & Collaborators

  • CellProthera

    lead INDUSTRY

Principal Investigators

  • Frederic Flandrin · CellProthera

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-27
Primary Completion
2020-06-30
Completion
2021-07-31
FDA Device
Yes

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04198883 on ClinicalTrials.gov