MedTrace Logo

Biocellular-Cellular Regenerative Treatment Scaring Alopecia and Alopecia Areata

NCT03078686 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-04-16

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the safety and efficacy of the use of a biocellular mixture of emulsified adipose-derived tissue stromal vascular fraction (AD-tSVF) and high density platelet-rich plasma concentrate (HD- PRP). Additionally, comparison with clinical outcomes of adipose-derived cellular Stromal Vascular Fraction (AD-cSVF) + AD-tSVF + HD PRP; AD-cSVF + emulsified AD-tSVF + HD- PRP; emulsified AD-tSVF + HD PRP + AD-cSVF; AD-cSVF via intravenous infusion in treatment of Scaring Alopecias and Alopecia Areata. Control will be served by use of established clinical protocol of using platelet concentrates with Matristem Matrix (Acel) injected in the same fashion as the other ARMs within this study, and comparative analyses performed at the endpoint of this study.

Conditions

Interventions

PROCEDURE

tSVF by lipoaspiration

Lipoaspiration Harvest tSVF closed syringe microcannula harvest, Tulip GEMS microcannula syringe system

PROCEDURE

PRP Concentration

Preparation of High Density PRP Centrifugation per manufacturer directive, Emcyte II PurePRP System

PROCEDURE

Emulsification tSVF

Preparation of emulsified tSVF harvested adipose; Use of ACM Device; Micronization of tSVF through Sterile Screen

PROCEDURE

cSVF isolation and concentration

Healeon Centrifuge (CC1000) enzymatic digestion, incubation, isolation and neutralization to prepare cSVF concentrates

PROCEDURE

cSVF in Normal Saline IV

cSVF + NS for IV Placement

Sponsors & Collaborators

  • Global Alliance for Regenerative Medicine

    collaborator OTHER

  • Regeneris Medical

    lead OTHER

Principal Investigators

  • Robert W Alexander, MD · GARM-USA

  • Ken Williams, DO · IIMSC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-17
Primary Completion
2025-01-22
Completion
2025-06-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03078686 on ClinicalTrials.gov