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Trial record 1 of 1 for:    Kerastem
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STYLE -- A Trial of Cell Enriched Adipose For Androgenetic Alopecia (STYLE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02503852
First Posted: July 21, 2015
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kerastem Technologies, LLC
  Purpose
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.

Condition Intervention Phase
Alopecia, Androgenetic Device: Puregraft System Device: Celution System Procedure: Kerastem Therapy Procedure: Liposuction Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Subcutaneous Transplantation of Autologous Cell Enriched Adipose Tissue For Follicular Niche Stimulation in Early Stage Alopecia Androgenetica (STYLE): a Randomized, Blinded, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Kerastem Technologies, LLC:

Primary Outcome Measures:
  • Safety & Tolerability Assessment of SAE/AE [ Time Frame: 6 months ]
    Assessment of SAE/AE


Secondary Outcome Measures:
  • Hair Growth Assessment by Trichogram [ Time Frame: 6 months ]
    Assessment by Trichogram

  • Hair Density Assessment by Trichogram [ Time Frame: 6 months ]
    Assessment by Trichogram

  • Global Photography Photographic assessment of scalp hair [ Time Frame: 6 months ]
    Photographic assessment of scalp hair

  • Hair Investigator Satisfaction Survey [ Time Frame: 6 months ]
    Assessment of treatment outcome by treating physician


Enrollment: 70
Study Start Date: November 2015
Estimated Study Completion Date: October 31, 2017
Estimated Primary Completion Date: October 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fat + High Dose ADRC
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
The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Device: Celution System
The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Procedure: Kerastem Therapy
The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Procedure: Liposuction
Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
Experimental: Fat + Low Dose ADRC
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
The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Device: Celution System
The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Procedure: Kerastem Therapy
The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Procedure: Liposuction
Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
Experimental: Fat Alone
Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.
Device: Puregraft System
The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Procedure: Liposuction
Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
Sham Comparator: No Fat Control
Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.
Procedure: Liposuction
Tissue collection involving the micro-harvest of subcutaneous adipose tissue.

Detailed Description:

The STYLE Trial is a prospective, randomized, multi-center device trial intended to evaluate the safety and efficacy 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. Patients may be included if they are undergoing an elective cosmetic liposuction. Following informed consent and screening evaluations, eligible subjects will undergo pre-operative testing. Subjects will then undergo a fat harvest using local anesthesia with or without conscious sedating. Subjects will be randomly assigned to receive a fat graft cell enriched with ADRCs (available in two different doses),a fat graft without cell enrichment using a visually-matched blood saline solution (fat alone control), or a saline injection (no-fat control) in a 2:2:2:1 ratio.

While undergoing liposuction, lipoaspirate will be processed in the Puregraft System to remove the lipoaspirate of impurities and in the Celution System to isolate and concentrate ADRCs. After the liposuction is completed), patients will have, under a ring block local anesthesia (see further description below), a subcutaneous scalp injection of either Puregraft purified autologous fat or saline (no-fat control) followed by a separate second injection, of either ADRCs (available in two different doses),a visually-matched blood saline solution (fat alone control), or saline (no-fat control) in a 2:2:2:1 ratio.

The STYLE Clinical Trial will have a sample size of 70 patients at up to eight (8) centers.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males with a diagnosis of Alopecia Androgenetica
  2. Females with a diagnosis of Alopecia Androgenetica
  3. Males with hair loss consistent with Grades III, IIIA, III-Vertex, IV, IV-A, based on Norwood-Hamilton Scale (Figure 1)
  4. Females with hair loss consistent with Grades I-3, I-4, II-1, II-2 based on the Savin Scale (Figure 2)
  5. Provide written informed consent and comply with the study requirements
  6. 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.
  7. Subject is willing to maintain a consistent hair length and natural hair color, without the use of any coloring agents, during the study period.
  8. Ability to complete study procedures, patient surveys, and pictures.
  9. Subject is ≥ 18 years of age.
  10. Body Mass Index < 40kg/m2

Exclusion Criteria:

  1. 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
  2. Treatment with an investigational product or procedure within 30 days or plans to participate in another clinical study
  3. Subject who has previously failed or has been deemed non-responsive to a previous experimental hair loss treatment.
  4. Subject must have no previous hair transplant, cell treatment, micro needling, or any other treatment in the last 6 months in the scalp.
  5. 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.).
  6. History of autoimmune disease or organ transplantation or a patient on immunosuppressive medication(s).
  7. Diagnosis of cancer, receiving active treatment
  8. Active systemic infection
  9. Requires chronic antibiotics, systemic corticosteroids
  10. 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.
  11. Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator
  12. Prior surgery in the treatment area
  13. 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
  14. Pregnant or lactating women or women trying to become pregnant
  15. Known allergic reaction to components of study treatment and/or study injection procedure
  16. Subject has any disorder that may prevent compliance to study procedures and visits
  17. Subject who is part of the study staff, a family member or friend
  18. Diabetes or thyroid disorder
  19. Subject who has a sensitive, irritated, or abraded scalp area.
  20. Women who have an alternate diagnosis that is associated with hair loss.
  21. Body Mass Index < 18kg/m2
  22. Clinically significant abnormal findings on laboratory screening panels, including hemoglobin ≤ 10 g/dL.
  23. Hepatic dysfunction, as defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin levels > 1.5 times the upper limit of normal range (x ULN) prior to randomization.
  24. Chronic renal insufficiency as defined as a serum creatinine > 1.2 mg/dL for women and > 1.5 mg/dL for men.
  25. An elevated PT/PTT, INR, or platelet count < 100 x 109/L
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503852


Locations
United States, California
Tower Outpatient Surgery Center--Dr. Joel Aronowitz
Los Angeles, California, United States, 920048
United States, Florida
Foundation For Hair Restoration
Miami, Florida, United States, 33143
United States, New Jersey
Glasgold Surgery Group
Highland Park, New Jersey, United States, 08904
United States, New York
Laser & Skin Surgery Center of New York
New York, New York, United States, 10016
Sponsors and Collaborators
Kerastem Technologies, LLC
Investigators
Principal Investigator: Ken Washenik, MD Bosley Medical/NYU
  More Information

Publications:
Responsible Party: Kerastem Technologies, LLC
ClinicalTrials.gov Identifier: NCT02503852     History of Changes
Other Study ID Numbers: 003-A-II
First Submitted: July 17, 2015
First Posted: July 21, 2015
Last Update Posted: August 21, 2017
Last Verified: August 2017

Keywords provided by Kerastem Technologies, LLC:
Female Pattern Baldness
Male Pattern Baldness
Genetic Alopecia
Androgenic Alopecia
Hair Loss

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical