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

NCT03272191 | Withdrawn

• 1 other identifier: ADI-ME-SMI-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Subacute Myocardial Infarction

Keywords

MI; Infarction; Infarct; Subacute MI; stem cell

Outcome Measures

Primary Outcomes (1)

• Improved cardiac function

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

  3 and 6 months after intervention

Secondary Outcomes (1)

• Adverse Event

  Duration of study

Interventions

Liposuction and stem cell implantation PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Ageless Regenerative Institute: lead

Study Sites (1)

Ageless Regenerative Institute LLC

Aventura, Florida, 33180, United States

Location

MeSH Terms

Conditions

Infarction

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Sharon McQuillan, MD

  Ageless Regenerative Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: September 5, 2017
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2018
• Last Updated: September 5, 2017

Record last verified: 2017-07

Locations

US (1)