AGA Biocellular Stem/Stromal Hair Regenerative Study
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“AGA Biocellular Stem/Stromal Hair Regenerative Study”
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 PRPAR II system to concentrate Platelets via using manufacturer standard protocol
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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
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Biocellular Regenerative Therapy in Hair Loss: Use of High Density Platelet-Rich Plasma Concentrates and Cell-Enriched Emulsified Adipose-Derived Tissue Stromal Vascular Fraction
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NCT02849470
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