AGA Biocellular Stem/Stromal Hair Regenerative Study

NCT02849470 | Withdrawn Phase 1 DMC

• 1 other identifier: GARM 6.1.16
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

1. 1.HD-PRP + Matristem Matrix (ACell)
2. 2.Experimental: HD-PRP + Emulsified AD-tSVF
3. 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.

Conditions

Hair Disease

Keywords

Adipose Stem/Stromal Cells; PRP; SVF; Cell Therapy; Alopecia; GF

Outcome Measures

Primary Outcomes (1)

• Safety-Tolerability Assess of SAE/AE Assessment of SAE/AES

  Safety-Tolerability Assess of SAE/AE

  6 months

Secondary Outcomes (5)

• Hair Growth Trichogram

  12 Months

• Hair Density Trichogram

  12 Months

• Global Photometric Scalp Hair

  12 Months

• Hair Investigator Satisfaction

  12 Months

• Patient Satisfaction Survey

  12 Months

Study Arms (3)

ARM 1

ACTIVE COMPARATOR

Control: 1) HD-PRP + Matristem Matrix (ACell) (Current Standard of Care); 2) Intradermal injections of hair loss 3) Platelet Rich Plasma 4) Matristem Matrix (ACell)

Procedure: Intradermal Injection in hair loss; Procedure: Platelet Rich Plasma; Procedure: MatriStem Matrix (ACell) - Current Standard of Care; Procedure: HD-PRP (High Density Platelet Rich Plasma)

ARM 2

ACTIVE COMPARATOR

1. Experimental: HD-PRP + Emulsified AD-tSVF; Intervention: 2. Platelet Rich Plasma 3. Adipose Derived Stem/Stromal Cells 4. Intradermal injections of hair loss

Procedure: Intradermal Injection in hair loss; Procedure: Platelet Rich Plasma; Procedure: Adipose Derived Stem/Stromal Cells; Procedure: HD-PRP (High Density Platelet Rich Plasma); Procedure: Emulsified AD-tSVF

ARM 3

EXPERIMENTAL

Experimental: HD- PRP + Emulsified AD-tSVF + Emulsified AD-cSVF; Intervention: Intradermal injections of hair loss 1. Platelet Rich Plasma 2. Adipose Derived Stem/Stromal Cells 3. Stem/Stromal Cell Isolation 4. Intradermal injections of hair loss

Procedure: Intradermal Injection in hair loss; Procedure: Platelet Rich Plasma; Procedure: Adipose Derived Stem/Stromal Cells; Procedure: Stem/Stromal Cellular Isolation (Digestive); Procedure: HD-PRP (High Density Platelet Rich Plasma); Procedure: Emulsified AD-tSVF; Procedure: Emulsified AD-cSVF

Interventions

Intradermal Injection in hair loss PROCEDURE

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

Also known as: ARM 1, Matricell (ACell), Platelet Rich Plasma

ARM 1; ARM 2; ARM 3

Platelet Rich Plasma PROCEDURE

Growth factors and cytokines to promote healing and vascular supply

Also known as: ARM 1, ARM 2, ARM 3

ARM 1; ARM 2; ARM 3

Adipose Derived Stem/Stromal Cells PROCEDURE

Harvesting Adipose Lipoaspirate with Microcannula System

Also known as: ARM 2 and ARM 3, Platelet Rich Plasma, Emulsification of Adipose Derived tSVF, Intradermal Injection in hair loss

ARM 2; ARM 3

Stem/Stromal Cellular Isolation (Digestive) PROCEDURE

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

Also known as: ARM 3, Platelet Rich Plasma, Emulsification of Adipose Derived cSVF, Intradermal injection in hair loss

ARM 3

MatriStem Matrix (ACell) - Current Standard of Care PROCEDURE

ARM 1

HD-PRP (High Density Platelet Rich Plasma) PROCEDURE

ARM 1; ARM 2; ARM 3

Emulsified AD-tSVF PROCEDURE

ARM 2; ARM 3

Emulsified AD-cSVF PROCEDURE

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

ARM 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Healeon Medical Inc: lead
• Ministry of Health, Honduras: collaborator
• Robert W. Alexander, MD: collaborator
• Terry, Glenn C., M.D.: collaborator

Study Sites (1)

Kenneth Williams, DO

Irvine, California, 92618, United States

Location

Related Publications (5)

• Understanding Adipose-derived Stromal Vascular Fraction (AD-SVF) Cell Biology and Use on the Basis of Cellular, Chemical, Structural and Paracrine Components: A Concise Review

  BACKGROUND

• Alexander RW, Harrell DB. Autologous fat grafting: use of closed syringe microcannula system for enhanced autologous structural grafting. Clin Cosmet Investig Dermatol. 2013 Apr 8;6:91-102. doi: 10.2147/CCID.S40575. Print 2013.

  PMID: 23630430 BACKGROUND

• Understanding Mechanical Emulsification (Nanofat) Versus Enzymatic Isolation of Tissue Stromal Vascular Fraction (tSVF) Cells from Adipose Tissue: Potential Uses in Biocellular Regenerative Medicine

  BACKGROUND

• Zuk, P., Adipose-Derived Stem Cells in Tissue Regeneration. Review, Hindawi Publlishing Coripration, ISRN Stem Cells, Volume 2013, Artilce ID 713959, http://dx.doi.org/10.1155/2013/713959

  BACKGROUND

• Tobita M, Tajima S, Mizuno H. Adipose tissue-derived mesenchymal stem cells and platelet-rich plasma: stem cell transplantation methods that enhance stemness. Stem Cell Res Ther. 2015 Nov 5;6:215. doi: 10.1186/s13287-015-0217-8.

  PMID: 26541973 BACKGROUND

MeSH Terms

Conditions

Hair Diseases; Alopecia

Interventions

Injections, Intradermal; Digestion

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Hypotrichosis; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Ryan Welter, MD, PhD, MD,PhD

  Regeneris

  STUDY DIRECTOR

• Marco Barusco, MD

  Brusco Clinic

  STUDY DIRECTOR

• Kenneth Williams, DO

  Irvine Institute Medicine & Cosmetic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: July 29, 2016
• Study Start: August 14, 2016
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

US (1)