Safety Analysis of Implantation of Stromal Vascular Fraction

Safety Issues Clinical Trial

Official title:

Safety Analysis of Implantation of Stromal Vascular Fraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226093
• Other study ID #: ADI-SS-001
• Status: Completed
• Phase: N/A
• First received: July 20, 2017
• Last updated: July 20, 2017
• Start date: January 1, 2015
• Est. completion date: June 1, 2017

Study information

• Verified date: July 2017
• Source: Bioheart, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 676
• Est. completion date: June 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 97 Years

Eligibility

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

Related Conditions & MeSH terms

• Safety Issues

Intervention

Procedure:
• Stromal Vascular Fraction
The fat was separated via centrifuge to isolate the SVF and the cells were delivered intraarticularly, intravenously, intrathecally, or intradiscally directly into the same patient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bioheart, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Collection of adverse events	12 months