Clinical Trial: AGA Biocellular Stem/Stromal Hair Regenerative Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Biocellular Regenerative Therapy in Hair Loss: Use of High Density Platelet-Rich Plasma Concentrates and Cell-Enriched Emulsified Adipose-Derived Tissue Stromal Vascular Fraction
Brief 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
- HD-PRP + Matristem Matrix (ACell)
- Experimental: HD-PRP + Emulsified AD-tSVF
- 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 + Ma
Detailed Summary:
Detailed Description:
The cosmetic discipline of hair restoration is rooted in numerous landmark studies and progressive medical science in the medical literature. , , , , With the advent of advance theories and science within the scope of regenerative medicine, numerous reports are noted in the literature. , , , , , using biological modalities, e.g., HD-PRP concentrates defined as > 4-6 times patient circulating baselines, for stimulation of scalp tissues and hair follicles in androgenetic alopecic (AGA).
Design of this study is intended to be a prospective, randomized, multicenter trial with blinding of outcomes for independent observer, clinical provider and patient observation/satisfaction studies. The study proposes adipose-derived (AD) biocellular material when mixed with platelet high density concentrates (HD-PRP) offers a potential advantage for a markedly more effective therapeutic profile in areas of follicular miniaturization, tissue age related senescence, and effect the decreased vascular capabilities by stimulation of vasculoneogenesis. The benefits of using autologous adipose-derived stem/stromal cell (ADSCs) populations are cell proliferation and vasculogenesis that is intrinsically linked with native immunomodulatory capacities. Reports describing the safety and efficacy of this biocellular combination have been reported in peer reviewed literature. , In the second and third arm of this study, the use of regenerative protocols currently being utilized in the treatment of degenerative musculoskeletal conditions is employed. These protocols feature the use of an emulsified AD-tSVF and emulsified cell enriched AD-cSVF containing the full heterogeneous stem/stromal cell population and matrix that is injected into the regions of scalp containing the microenvironment (niche) of the hair follicle. In Arm 3, ce
Sponsor: Healeon Medical Inc
Current Primary Outcome: Safety-Tolerability Assess of SAE/AE Assessment of SAE/AES [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Hair Growth Trichogram [ Time Frame: 12 Months ]Growth Assessment by Trichogram [ Designated as safety issue: No ] Assessment by Trichogram
- Hair Density Trichogram [ Time Frame: 12 Months ]Hair Density Assessment Trichogram [ Designated as safety issue: No ] Assessment by Trichogram
- Global Photometric Scalp Hair [ Time Frame: 12 Months ]Global Photographic assessment scalp hair Photographic assessment of scalp hair by independent observer
- Hair Investigator Satisfaction [ Time Frame: 12 Months ]Hair Investigator Satisfaction Survey [ Designated as safety issue: No ] Assessment of treatment outcome by treating physician
- Patient Satisfaction Survey [ Time Frame: 12 Months ]Patient Satisfaction Survey [Designated as safety issue: No] Assessment of treatment Outcomes by patient.
Original Secondary Outcome: Same as current
Information By: Healeon Medical Inc
Dates:
Date Received: July 27, 2016
Date Started: August 2016
Date Completion: June 2018
Last Updated: March 13, 2017
Last Verified: March 2017
