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WithdrawnNCT03272191Updated Sep 5, 2017

Study to Assess Safety & Effects of Autologous ADSCs During Recovery Phase of ST-Elevation MI Effects of Autologous ADSC Implantation During Subacute Recovery Phase of ST-Elevation Myocardial Infarction

An interventional study of Liposuction and stem cell implantation in Subacute Myocardial Infarction, sponsored by Ageless Regenerative Institute. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-09-05.

Sponsored by Ageless Regenerative Institute · Not applicable, Interventional, and Treatment

Why this study was withdrawn
company dissolved
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe? and 2) Is treatment effective in improving cardiac function and clinical outcomes?

Read the detailed description

This will be an open-label, non-randomized multi-center study of ASC implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The injection catheter will be used for delivery of the ASCs therapy.

The adipose tissue specimen will be collected mainly from the patient's abdomen using a liposuction cannula. The adipose tissue may be collected from other areas if necessary The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred to an injection/infusion catheter for delivery into the akinetic myocardial scar in the region of a previous infarct

02

Conditions studied

  • Subacute Myocardial Infarction

Keywords

  • MI
  • Infarction
  • Infarct
  • Subacute MI
  • stem cell
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Males and Females between Age 18 and 80 years.
  • Defined subacute myocardial infarction between 9-90 days from screening
  • Left ventricular ejection fraction at screening of ≤ 50%, with 2 or more contiguous areas of severe wall motion abnormality on resting echocardiography.
  • Patients must have a minimum myocardial wall thickness of 5mm
  • Need or feasibility for re-vascularization has been ruled out by coronary angiogram or noninvasive stress testing.
  • Stable for at least 14 days on optimal medical management including:
  • Plavix/asprin therapy, anticoagulation therapy, cholesterol lowering agent, beta blocker, ACE inhibitor or ARB blocker Up to date on all age and gender appropriate cancer screening per American Cancer Society (Refer to section 9.3 for more details).

Exclusion criteria

Exclusion Criteria:

  • Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
  • Life expectancy \< 6 months due to concomitant illnesses.
  • NYHA CHF Class 4
  • Severe valvular or other non-ischemic myocardial disease.
  • Mechanical complications of the index acute myocardial infarction including but not limited to rupture of the mitral valve with resultant development of mitral regurgitation, rupture of the left ventricular free wall and rupture of the interventricular septum.
  • Previous severe reaction to radiocontrast agents
  • Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
  • Serum creatinine > 2.5 mg/dL or end stage renal disease unless on dialysis.
  • Active infectious disease and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. If the panel includes antibodies to the HBV-cAg and HBV-sAg, then an expert will be consulted as to patient eligibility based on the patient's infectious status
  • Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
  • Patients on chronic immunosuppressive transplant therapy
  • Systolic blood pressure (supine) ≤90 mmHg;
  • Resting heart rate > 100 bpm;
  • Active clinical infection within one week of enrollment.
  • Cerebrovascular accident within 6 months prior to study entry
  • Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
  • History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
  • Unwilling and/or not able to give written informed consent.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • ProcedureLiposuction and stem cell implantation

    The adipose tissue specimen will be collected mainly from the patient's abdomen using a liposuction cannula. The adipose tissue may be collected from other areas if necessary The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred to an injection/infusion catheter for delivery into the akinetic myocardial scar in the region of a previous infarct

05

What researchers measure

Primary outcomes

  1. Improved cardiac function

    Improvement is observed in cardiac function as assessed by echocardiographic LV function (EF)

    Time frame: 3 and 6 months after intervention

Secondary outcomes

  1. Adverse Event

    The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.

    Time frame: Duration of study

06

Study locations

1 site
  • Ageless Regenerative Institute LLC
    Aventura, Florida 33180, United States
07

Registry details

Key details

Study ID
NCT03272191
Lead sponsor
Ageless Regenerative Institute
Responsible party
Sponsor
First posted
Sep 5, 2017
Start date
Sep 2016
Primary completion
Sep 2017 (estimated)
Completion
Dec 2018 (estimated)
Last update
Sep 5, 2017

Study contacts

Sharon McQuillan, MD
principal investigator · Ageless Regenerative Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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