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Heart AttackPhase 1/2SingXpandNCT04198883

SINGaporean Program Performed With an eXPANsion Medical Device (SingXpand)

A Phase 1/2 study testing Protheracytes in people with Heart Attack, run by CellProthera at 1 site in Singapore.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Heart Attack
What is being tested?
Protheracytes
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteSingapore
Study dates
27 Nov 2018to 31 Jul 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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.
  • History of metallic foreign body in their eye
  • Former or current aortic dissection
  • Inadequate bone marrow function: Haemoglobin < 10 g/dL and Platelet count < 100 x 109 / L
  • Previous G-CSF or other Hematopoietic Growth Factor administrations.
  • Blood transfusion(s) within the previous 4 weeks (to exclude potential non-autologous ACPs (Angiogenic Cells Precursors) in the harvested blood).
  • Hepatic failure or history of liver cirrhosis or hepatic severe impairment.
  • Constitutional or acquired coagulopathy
  • Treated chronic renal failure, or haemodialysis or renal severe impairment (creatinine clearance < 30ml/min).
  • 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.
  • History of prior mediastinal radiation exposure
  • 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).
  • Chronic immunomodulatory or cytotoxic drug treatment intake.
  • Active bleeding or major surgery within 1 month.
  • Human immunodeficiency HIV1-2, HTLV1, HTLV2
  • History or current Hepatitis B (prior vaccination accepted)
  • History or current Hepatitis C
  • Syphilis
  • Chronic Obstructive Pulmonary Disease.
  • Active participation in any other clinical trials
  • Current or recent treatment (within the 60 days period before PTCA and stent(s) implantation) with another investigational drug or procedure.
  • Any other co-existing conditions that will preclude participation in the study or compromise ability to give informed consent.
  • Requirement of i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump) initiated 24 hours before cMRI.
  • Splenomegaly
  • Phenylketonuria
  • History of iron-Dextran allergy
  • History of murin protein allergy

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • NHCS

    Singapore, 169609

Other trials in Singapore

About this study

Official title: 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.

Read the 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
Being tested
Protheracytes
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProtheracytesCombination product

    Also called Biocardia Helix catheter

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

Study groups in NCT04198883
Study groupRoleWhat they receive
ProtheracytesExperimentalSingle arm study : Stem cells injection called Protheracytes
Receives: Combination Product: Protheracytes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACE,SAE and AE

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

    Measured: 1 year

Secondary outcomes (1)

  1. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2019
  2. Study start27 Nov 2018
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion31 Jul 2021 (estimated)

Why it stopped: Because of the Impact of CoviD19 pandemy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
the design : pilot, single-arm, open-labelled study
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04198883
Sponsor's protocol ID
CellProthera
Acronym
SingXpand
Status last verified
Jul 2019
First submitted
4 Jul 2019
Last updated
10 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Protheracytes in people with Heart Attack, run by CellProthera at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACE,SAE and AE (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04198883.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.

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