AGA Biocellular Stem/Stromal Hair Regenerative Study

Summary

Purpose 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) as compared with adipose-derived cell-enriched SVF (AD-cSVF) + AD-tSVF and HD- PRP concentrates in treatment of androgenetic alopecia (AGA) and Female Pattern Hair Loss (FPHL).

Assigned Interventions

1. HD-PRP + Matristem Matrix (ACell)
2. Experimental: HD-PRP + Emulsified AD-tSVF
3. Experimental: HD- PRP + Emulsified AD-tSVF + Emulsified AD-cSVF Device: Tulip Microcannula Closed Syringe For All Lipoaspiration (2.11 mm Diameter, offset Carraway) Centrifugation technique to acquire concentrated platelets (per manufacturer's approved protocol) Healeon ACM Emulsification System that prepares microcannula harvested AD-tSVF for small needle (25g) retrograde threaded intradermal scalp injection.

Healeon Centricyte 1000 system for cellular isolation of AD-cSVF from AD-tSVF and testing by Flow Cytometry (ORFLO MoxiFlow) Procedure: Closed syringe microcannula lipoaspiration (AD-tSVF) Procedure: Emulsification of AD-tSVF via Healeon ACM Protocol (Newbury Park, CA, USA) Procedure: Biocellular mix of emulsified AD-tSVF and HD-PRP for intradermal injection in scalp; (Arm 2) Procedure: Cellular isolation (AD-cSVF) Centricyte 1000 incubation/shaker system using GMP certified, sterile Liberase MNP-S (Roche #06297790001) for enzymatic digestion manufacturer standard protocol. Creation of emulsified AD-tSVF + PRP + cell-enriched AD-cSVF for intradermal injection in scalp (Arm 3) Sham Comparator: No Fat Control using Emcyte II PRP Concentrate + Matristem (Acell) for subcutaneous scalp injection patterned per square centimeter of scalp. Procedure: Emcyte Pure PRP® II system to concentrate Platelets via using manufacturer standard protocol

Conditions

• Hair Disease

Interventions

PROCEDURE

Intradermal Injection in hair loss

Comparative Injection of Control (PRP \& Acel) in hair loss; 2) Intradermal Injection in hair loss

PROCEDURE

Platelet Rich Plasma

Growth factors and cytokines to promote healing and vascular supply

PROCEDURE

Adipose Derived Stem/Stromal Cells

Harvesting Adipose Lipoaspirate with Microcannula System

PROCEDURE

Stem/Stromal Cellular Isolation (Digestive)

Cell isolation and concentration add back to AD-stem/stromal cells utilizing Centricyte 1000 Protocol

PROCEDURE

MatriStem Matrix (ACell) - Current Standard of Care

PROCEDURE

HD-PRP (High Density Platelet Rich Plasma)

PROCEDURE

Emulsified AD-tSVF

PROCEDURE

Emulsified AD-cSVF

Stem/Stromal Cellular Isolate Added Back to Emulsified AD-tSVF

Sponsors & Collaborators

• Ministry of Health, Honduras

  collaborator OTHER_GOV

• Robert W. Alexander, MD

  collaborator UNKNOWN

• Terry, Glenn C., M.D.

  collaborator INDIV

• Healeon Medical Inc

  lead INDUSTRY

Principal Investigators

• Ryan Welter, MD, PhD, MD,PhD · Regeneris

• Marco Barusco, MD · Brusco Clinic

• Kenneth Williams, DO · Irvine Institute Medicine & Cosmetic Surgery

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-08-14

Primary Completion

2027-07-31

Completion

2028-07-31

Countries

• United States

Study Locations