Clinical Trial: Biocellular-Cellular Regenerative Treatment Scaring Alopecia and Alopecia Areata

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Biocellular Regenerative Therapy in Treating Scaring Alopecias and Alopecia Areata: Use of High Density Platelet-Rich Plasma Concentrates and Cell-Enriched Emulsified Adipose-Derived Tissue Stromal Va

Brief 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.

Detailed Summary:

The aesthetic surgical & cosmetic discipline of hair restoration is rooted in numerous landmark studies and progressive medical science in the medical literature. With the advent of advanced theories and science using cellular and platelet-derived growth factors within the scope of regenerative medicine, have been well established in a number of peer-reviewed publications, The use of biological modalities, e.g., HD-PRP concentrates (defined as > 4-6 times patient circulating baselines), have become recognized in a number of disciplines, including value of stimulation of scalp tissues and hair follicles in androgenetic alopecia (AGA). (See Clinical Trial Study STRAAND). A "retrograde" filling technique creating a potential space and subsequently injecting into this space will insure uniformity of placement and spread of the delivered treatment modality.

This study design is intended to be a prospective, randomized, multi-center trial with blinding of outcomes for independent observers, clinical provider, and patient observation/satisfaction study comparatives. The study proposes adipose-derived cellular and stromal components when mixed with platelet high density concentrates (HD-PRP) offers an advantage to produce a markedly more effective therapeutic profile in in treating patients with scaring alopecia's (SA) and alopecia areata (AA), tissue age related senescence, and encourage vascular capabilities by stimulation of vasculoneogenesis. The benefits of using autologous adipose-derived stem & stromal cell (ADSC) populations are cell proliferation and vasculogenesis that is intrinsically linked with native inflammatory modulation and immunomodulatory capacities. Reports describing the safety and efficacy of this biocellular combination have been reported in peer reviewed literature.

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Sponsor: Regeneris Medical

Current Primary Outcome: Safety of Intervention [ Time Frame: 6 months ]

Assess Adverse Events & Severe Adverse Events


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hair Growth Assessment [ Time Frame: 12 months ]
    Trichogram Assessment Hair Growth
  • Photographic Assessment Scalp Hair [ Time Frame: 12 months ]
    lobal Photographic Assessment of Scalp Hair
  • Investigator Satisfaction Survey [ Time Frame: 12 months ]
    Treating Investigator Outcome Survey
  • Patient Satisfaction Outcome Survey [ Time Frame: 12 months ]
    Patient Assessment of Outcome


Original Secondary Outcome: Same as current

Information By: Regeneris Medical

Dates:
Date Received: March 6, 2017
Date Started: February 17, 2017
Date Completion: June 22, 2019
Last Updated: March 31, 2017
Last Verified: March 2017