STYLE -- A Trial of Cell Enriched Adipose For Androgenetic Alopecia

NCT02503852 | Completed Results

• 1 other identifier: 003-A-II
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective of this study is to evaluate the safety and feasibility of the Celution and Puregraft Systems in the processing and preparation of an autologous fat graft enriched with adipose-derived regenerative cells (ADRCs) in the treatment of early alopecia androgenetica.

Conditions

Alopecia, Androgenetic

Keywords

Female Pattern Baldness; Male Pattern Baldness; Genetic Alopecia; Androgenic Alopecia; Hair Loss

Outcome Measures

Primary Outcomes (1)

• Safety & Tolerability Assessment of SAE/AE

  Safety \& Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE

  Enrollment to 52 weeks

Secondary Outcomes (2)

• Terminal (Non-Vellus) Hair Count--Change From Baseline

  Enrollment to 52 weeks

• Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4

  Enrollment to 24 weeks

Study Arms (4)

Fat + High Dose ADRC

EXPERIMENTAL

Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 1,000,000 ADRC prepared with the Celution System per square centimeter of scalp.

Device: Puregraft System; Device: Celution System; Procedure: Kerastem Therapy; Procedure: Liposuction

Fat + Low Dose ADRC

EXPERIMENTAL

Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 500,000 ADRC prepared with the Celution System per square centimeter of scalp.

Device: Puregraft System; Device: Celution System; Procedure: Kerastem Therapy; Procedure: Liposuction

Fat Alone

ACTIVE COMPARATOR

Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.

Device: Puregraft System; Procedure: Liposuction

No Fat Control

PLACEBO COMPARATOR

Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.

Procedure: Liposuction

Interventions

Puregraft System DEVICE

The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.

Fat + High Dose ADRC; Fat + Low Dose ADRC; Fat Alone

Celution System DEVICE

The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.

Fat + High Dose ADRC; Fat + Low Dose ADRC

Kerastem Therapy PROCEDURE

The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.

Fat + High Dose ADRC; Fat + Low Dose ADRC

Liposuction PROCEDURE

Tissue collection involving the micro-harvest of subcutaneous adipose tissue.

Fat + High Dose ADRC; Fat + Low Dose ADRC; Fat Alone; No Fat Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males with a diagnosis of Alopecia Androgenetica
• Females with a diagnosis of Alopecia Androgenetica
• Males with hair loss consistent with Grades III, IIIA, III-Vertex, IV, IV-A, based on Norwood-Hamilton Scale (Figure 1)
• Females with hair loss consistent with Grades I-3, I-4, II-1, II-2 based on the Savin Scale (Figure 2)
• Provide written informed consent and comply with the study requirements
• For women of childbearing potential: Negative pregnancy test at screening visit plus subject agrees to maintain two forms of contraception for the duration of the study.
• Subject is willing to maintain a consistent hair length and natural hair color, without the use of any coloring agents, during the study period.
• Ability to complete study procedures, patient surveys, and pictures.
• Subject is ≥ 18 years of age.
• Body Mass Index \< 40kg/m2

You may not qualify if:

• Subjects who have used minoxidil, or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening
• Treatment with an investigational product or procedure within 30 days or plans to participate in another clinical study
• Subject who has previously failed or has been deemed non-responsive to a previous experimental hair loss treatment.
• Subject must have no previous hair transplant, cell treatment, micro needling, or any other treatment in the last 6 months in the scalp.
• Subject is currently suffering from an active autoimmune disease such as serum lupus erythematosus, or alopecia areata. Subject is currently suffering from dermatologic condition in the treatment area or has a significant scar in the hair treatment area that, in the opinion of the investigator, will make hair growth difficult (such as systemic burns, etc.).
• History of autoimmune disease or organ transplantation or a patient on immunosuppressive medication(s).
• Diagnosis of cancer, receiving active treatment
• Active systemic infection
• Requires chronic antibiotics, systemic corticosteroids
• Use of systemic agents that increase bleeding or clotting, or disorders associated with these effects, including patients receiving GIIB/IIIa inhibitors within 2 weeks prior to the study procedure through to 1 week after the study procedure.
• Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator
• 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
• Pregnant or lactating women or women trying to become pregnant
• Known allergic reaction to components of study treatment and/or study injection procedure

Sponsors & Collaborators

• Kerastem Technologies, LLC: lead

Study Sites (4)

Tower Outpatient Surgery Center--Dr. Joel Aronowitz

Los Angeles, California, 920048, United States

Location

Foundation For Hair Restoration

Miami, Florida, 33143, United States

Location

Glasgold Surgery Group

Highland Park, New Jersey, 08904, United States

Location

Laser & Skin Surgery Center of New York

New York, New York, 10016, United States

Location

Related Publications (2)

• Festa E, Fretz J, Berry R, Schmidt B, Rodeheffer M, Horowitz M, Horsley V. Adipocyte lineage cells contribute to the skin stem cell niche to drive hair cycling. Cell. 2011 Sep 2;146(5):761-71. doi: 10.1016/j.cell.2011.07.019.

  PMID: 21884937 BACKGROUND

• Zhu M, Zhou Z, Chen Y, Schreiber R, Ransom JT, Fraser JK, Hedrick MH, Pinkernell K, Kuo HC. Supplementation of fat grafts with adipose-derived regenerative cells improves long-term graft retention. Ann Plast Surg. 2010 Feb;64(2):222-8. doi: 10.1097/SAP.0b013e31819ae05c.

  PMID: 20098110 BACKGROUND

MeSH Terms

Conditions

Alopecia

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Results Point of Contact

• Title: Eric Daniels, M.D., Chief Medical Officer
• Organization: Kerastem

edaniels@puregraft.com

858.348.8050

Study Officials

• Ken Washenik, MD

  Bosley Medical/NYU

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization via manual treatment assignment by the unblinded Clinical Supply Manager prior to the start of liposuction. Subjects randomized into the study are assigned their study Arm corresponding to the next available number in the computer-generated randomization schedule. Dose preparation ios performed by designated unblinded qualified personnel and supplied to the blinded treating team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects arm randomized prior to liposuction 2:2:2:1 ratio to one of 4 Arms. Low Dose ADR, High Dose ADRC, non enriched fat only, and no fat (control normal saline).

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 21, 2015
• Study Start: November 1, 2015
• Primary Completion: March 2, 2018
• Study Completion: March 2, 2018
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)