SINGaporean Program Performed With an eXPANsion Medical Device (SingXpand) (SingXpand)
Primary Purpose
Heart Attack
Status
Withdrawn
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Protheracytes
Sponsored by
About this trial
This is an interventional treatment trial for Heart Attack
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- NHCS
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Protheracytes
Arm Description
Single arm study : Stem cells injection called Protheracytes
Outcomes
Primary Outcome Measures
MACE,SAE and AE
Description, incidence and assessment of MACE (Major Adverse Cardiac Events), SAE and AE .
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04198883
Brief Title
SINGaporean Program Performed With an eXPANsion Medical Device (SingXpand)
Acronym
SingXpand
Official Title
SINGaporean Program Performed With an eXPANsion Medical Device
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Because of the Impact of CoviD19 pandemy
Study Start Date
November 27, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CellProthera
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Attack
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
the design : pilot, single-arm, open-labelled study
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Protheracytes
Arm Type
Experimental
Arm Description
Single arm study : Stem cells injection called Protheracytes
Intervention Type
Combination Product
Intervention Name(s)
Protheracytes
Other Intervention Name(s)
Biocardia Helix catheter
Intervention Description
Intramyocardiac (LV) injection of stem cells with a dedicated catheter
Primary Outcome Measure Information:
Title
MACE,SAE and AE
Description
Description, incidence and assessment of MACE (Major Adverse Cardiac Events), SAE and AE .
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change of Cardiac function assessed by cMRI
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic Flandrin
Organizational Affiliation
CellProthera
Official's Role
Study Director
Facility Information:
Facility Name
NHCS
City
Singapore
ZIP/Postal Code
169609
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
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SINGaporean Program Performed With an eXPANsion Medical Device (SingXpand)
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