NCT03226093

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
676

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

July 20, 2017

Last Update Submit

July 20, 2017

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Collection of adverse events

    12 months

Study Arms (1)

Stromal Vascular Fraction

EXPERIMENTAL

Isolation of SVF from fat tissue for re-administration into the same patient

Procedure: Stromal Vascular Fraction

Interventions

Stromal Vascular FractionPROCEDURE

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

Stromal Vascular Fraction

Eligibility Criteria

Age15 Years - 97 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 21, 2017

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

June 1, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07