Safety Analysis of Implantation of Stromal Vascular Fraction

Bioheart

Status

Completed

Conditions

Safety Issues

Treatments

Procedure: Stromal Vascular Fraction

Study type

Interventional

Funder types

Industry

Identifiers

NCT03226093

ADI-SS-001

Details and patient eligibility

About

Stromal vascular fraction (SVF) can be isolated from fat (adipose) tissue in an outpatient in-clinic procedure. Platelet rich plasma (PRP) can be isolated from peripheral blood. The SVF includes a variety of different cells and growth factors where the adipocyte (fat cell) population has been removed. The use of SVF in the clinic for a variety of indications is analyzed for incidences of safety and tolerability.

Enrollment

676 patients

Sex

All

Ages

15 to 97 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 15 and 97
Able and willing to give written informed consent
Up to date on all age and gender appropriate cancer screening

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.
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.
Active infectious disease patients known to have tested positive for HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. Will have an expert 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