AGA Biocellular Stem/Stromal Hair Regenerative Study

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Hair Disease

In brief

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

Key facts

Study ID: NCT02849470
Run by: Healeon Medical Inc
People needed: 0
Starts: 2016-08-14
Expected to finish: 2028-07-31
Last updated by the study team: 2025-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Inclusion Criteria:
Males with a diagnosis of Androgenetic Alopecia (AGA).
Females with a biopsy proven diagnosis of Female Pattern Hair Loss (FPHL) excluding scaring or autoimmune disorders.
Males with hair loss consistent with Grades II, III, IIIA, III-Vertex, IV, IV-A, based on Norwood-Hamilton Scale.
Females with hair loss consistent with Grades I-3, I-4, II-1, II-2 based on the Savin Scale.
Demonstrated ability to legally provide written informed consent and comply with the study requirements
For women of childbearing potential with screening negative pregnancy test and subject agrees to avoid pregnancy with two forms of contraception for the duration of study
Subject is willing to maintain existing and consistent hair length and color.
Ability to complete study procedures, patient surveys, and photodocumentation.
Subject is ≥ 18 years of age.
Five (5) year cancer free period without treatment and no evidence of recurrence

You may not qualify if…

Subjects who have used oral spironolactone, finasteride, dutasteride, minoxidil, or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 12 months of study screening.
Simultaneous treatment with an investigational product or procedure within 30 days, or planned future participation in another clinical study
Subject has previously failed or has been deemed non-responsive to a previous experimental hair loss treatment.
Subject must have no previous hair transplant, PRP, biocellular treatments, micro needling, cold laser therapies, or any other scalp or hair loss treatment.
Subject with previously diagnosed or suspected of having active scaring alopecia, autoimmune diseases such as serum lupus erythematosus, or alopecia areata; unspecified dermatologic condition, or disorders that will make hair growth difficult (such as systemic burns, etc.).
History of or active diagnosis of autoimmune disease or organ transplantation or immunosuppressive medication(s).
Receiving active cancer treatment or have present or previous malignancies except a history of squamous or basal skin cell carcinoma with excision for cure.
Active systemic infection at the time of enrollment. If acquired afterwards, exclusion based on clinical judgment of investigator.
Use of chronic antibiotics and/or systemic corticosteroids.
Use of systemic agents that increase bleeding or clotting, or disorders associated with these effects, including patients receiving GIIB/IIIa inhibitors in the 2 weeks prior to the study procedure through to 1 week after the study procedure.
Clinically significant or current medical or psychiatric illness.
Prior surgery in the treatment area.
Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise dermatologic, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk of increased morbidity or mortality.
Pregnant or lactating female, or women trying to become pregnant.
Known allergic reaction to components of study treatment and/or study injection procedure
Subject has any disorder or any reason that may prevent compliance to study procedures and visits.
Employees or family members of the study staff.
Untreated or uncontrolled thyroid disorder (abnormal TSH/free T4) or diabetes mellitus (HgbA1C > 8.0).
Subject who has a sensitive, irritated, or abraded scalp area.
Women who have an alternate diagnosis that is associated with hair loss.
Clinically significant abnormal findings on laboratory screening panels:
Hemoglobin ≤ 10 g/dL
Hepatic dysfunction, as defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin levels > 1.5 times the upper limit of normal range prior to randomization.
Chronic renal insufficiency as defined as a serum creatinine > 1.2 mg/dL for women and > 1.5 mg/dL for men.
An elevated PT/PTT, INR,

Where it is running

Kenneth Williams, DO — Irvine, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.