ClinicalTrials.gov
ClinicalTrials.gov Menu

Biocellular-Cellular Regenerative Treatment Scaring Alopecia and Alopecia Areata (SAAA)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03078686
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : August 27, 2018
Sponsor:
Collaborator:
Global Alliance for Regenerative Medicine
Information provided by (Responsible Party):
Ryan Welter, MD, PhD, Regeneris Medical

Brief Summary:
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). Additionally, comparison with clinical outcomes of adipose-derived cellular Stromal Vascular Fraction (AD-cSVF) + AD-tSVF + HD PRP; AD-cSVF + emulsified AD-tSVF + HD- PRP; emulsified AD-tSVF + HD PRP + AD-cSVF; AD-cSVF via intravenous infusion in treatment of Scaring Alopecias and Alopecia Areata. Control will be served by use of established clinical protocol of using platelet concentrates with Matristem Matrix (Acel) injected in the same fashion as the other ARMs within this study, and comparative analyses performed at the endpoint of this study.

Condition or disease Intervention/treatment Phase
Alopecia Areata Scarring Alopecia Procedure: tSVF by lipoaspiration Procedure: PRP Concentration Procedure: Emulsification tSVF Procedure: cSVF isolation and concentration Procedure: cSVF in Normal Saline IV Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biocellular Regenerative Therapy in Treating Scaring Alopecias and Alopecia Areata: Use of High Density Platelet-Rich Plasma Concentrates and Cell-Enriched Emulsified Adipose-Derived Tissue Stromal Vascular Fraction (AD-tSVF)
Actual Study Start Date : February 17, 2017
Estimated Primary Completion Date : January 22, 2019
Estimated Study Completion Date : June 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control ARM 1
Control: 1) HD-PRP + Matristem Matrix (ACell) (Current Standard of Care); 2) Platelet Rich Plasma Concentrate)
Procedure: PRP Concentration
Preparation of High Density PRP Centrifugation per manufacturer directive, Emcyte II PurePRP System

Experimental: Emulsification tSVF + PRP ARM 2
HD-PRP + Emulsified AD-tSVF; Intervention: Platelet Rich Plasma Concentrate
Procedure: tSVF by lipoaspiration
Lipoaspiration Harvest tSVF closed syringe microcannula harvest, Tulip GEMS microcannula syringe system

Procedure: PRP Concentration
Preparation of High Density PRP Centrifugation per manufacturer directive, Emcyte II PurePRP System

Procedure: Emulsification tSVF
Preparation of emulsified tSVF harvested adipose; Use of ACM Device; Micronization of tSVF through Sterile Screen

Experimental: Emulsification tSVF + PRP + cSVF ARM 3
tSVF; PRP; cSVF cell enriched biocellular therapeutic mix
Procedure: tSVF by lipoaspiration
Lipoaspiration Harvest tSVF closed syringe microcannula harvest, Tulip GEMS microcannula syringe system

Procedure: PRP Concentration
Preparation of High Density PRP Centrifugation per manufacturer directive, Emcyte II PurePRP System

Procedure: Emulsification tSVF
Preparation of emulsified tSVF harvested adipose; Use of ACM Device; Micronization of tSVF through Sterile Screen

Procedure: cSVF isolation and concentration
Healeon Centrifuge (CC1000) enzymatic digestion, incubation, isolation and neutralization to prepare cSVF concentrates

Experimental: cSVF in Normal Saline IV ARM 4
cSVF + Normal Saline IV (500 cc) Infusion
Procedure: tSVF by lipoaspiration
Lipoaspiration Harvest tSVF closed syringe microcannula harvest, Tulip GEMS microcannula syringe system

Procedure: cSVF isolation and concentration
Healeon Centrifuge (CC1000) enzymatic digestion, incubation, isolation and neutralization to prepare cSVF concentrates

Procedure: cSVF in Normal Saline IV
cSVF + NS for IV Placement




Primary Outcome Measures :
  1. Safety of Intervention [ Time Frame: 6 months ]
    Assess Adverse Events & Severe Adverse Events


Secondary Outcome Measures :
  1. Hair Growth Assessment [ Time Frame: 12 months ]
    Trichogram Assessment Hair Growth

  2. Photographic Assessment Scalp Hair [ Time Frame: 12 months ]
    lobal Photographic Assessment of Scalp Hair

  3. Investigator Satisfaction Survey [ Time Frame: 12 months ]
    Treating Investigator Outcome Survey

  4. Patient Satisfaction Outcome Survey [ Time Frame: 12 months ]
    Patient Assessment of Outcome



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 to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males with a biopsy proven diagnosis of a Scaring alopecia (SA) or Alopecia Areata (AA)
  2. Females with a biopsy proven diagnosis of Scaring alopecia (SA) or Alopecia Areata (AA)
  3. Demonstrated ability to legally provide written informed consent and comply with the study requirements
  4. 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
  5. Subject is willing to maintain existing and consistent hair length and color.
  6. Ability to complete study procedures, patient surveys, and photodocumentation.
  7. Subject is ≥ 18 years of age.
  8. Five (5) year cancer free period without treatment and no evidence of recurrence

Exclusion Criteria:

  1. 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.
  2. Simultaneous treatment with an investigational product or procedure within 30 days, or planned future participation in another clinical study
  3. Subject has previously failed or has been deemed non-responsive to a previous experimental hair loss treatment.
  4. Subject must have no recent PRP, biocellular treatments, micro needling, cold laser therapies, or any other scalp or hair loss treatment.
  5. Subject with previously diagnosed or suspected unspecified dermatologic condition, or disorders that will make hair growth difficult (such as systemic burns, etc.).
  6. History of or active diagnosis of systemic autoimmune disease or organ transplantation or immunosuppressive medication(s).
  7. Receiving active cancer treatment or have present or previous malignancies except a history of squamous or basal skin cell carcinoma with excision for cure.
  8. Active systemic infection at the time of enrollment. If acquired afterwards, exclusion based on clinical judgment of investigator.
  9. Use of chronic antibiotics and/or systemic corticosteroids.
  10. 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.
  11. Clinically significant or current medical or psychiatric illness.
  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 of increased morbidity or mortality.
  14. Pregnant or lactating female, 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 or any reason that may prevent compliance to study procedures and visits.
  17. Employees or family members of the study staff.
  18. Untreated or uncontrolled thyroid disorder (abnormal TSH/free T4) or diabetes mellitus (HgbA1C > 8.0).
  19. Subject who has a sensitive, irritated, or abraded scalp area.
  20. Clinically significant abnormal findings on laboratory screening panels:

    • Hemoglobin > or = 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.
    • Elevated PT/PTT, INR,
    • Platelet count < 100 x 109/L

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): NCT03078686


Contacts
Contact: Ryan Welter, MD, PhD 508.345.5492 r.welter@regenerismedical.com
Contact: Ken Williams, DO 1.949.333.2999 drwilliams@iimsc.org

Locations
United States, California
Kenneth Williams, DO Recruiting
Irvine, California, United States, 92618
Contact: Ken Williams, DO    949-333-2999    drwilliams@iimcs.org   
Principal Investigator: Ryan Welter, MD, PhD         
United States, Massachusetts
Regeneris Medical Recruiting
North Attleboro, Massachusetts, United States, 02760
Contact: Ryan JP Welter, MD    508-345-5492    r.welter@regenerismedical.com   
Contact: Gabrielle Lewis    508.316.4268    g.lewis@regenerismedical.com   
Principal Investigator: Glenn C Terry, MD         
Principal Investigator: Robert W Alexander, MD         
Principal Investigator: Ryan JP Welter, MD,PhD         
United States, Montana
Regenevita LLC Recruiting
Stevensville, Montana, United States, 59870
Contact: Robert W Alexander, MD    406-777-5312    rwamd@garm-usa.com   
Contact: Susan Riley, CMA, Tech    +1.406.777.5312    irbtrials@gmail.com   
Sub-Investigator: Glenn C Terry, MD         
Principal Investigator: Robert W Alexander, MD         
Principal Investigator: Ryan Welter, MD, PhD         
Sub-Investigator: Robert Niedbalski, DO         
Sub-Investigator: Lawrence Samuels, MD         
Sub-Investigator: Marco Barusco, MD         
Principal Investigator: Ken Williams, DO         
Sponsors and Collaborators
Regeneris Medical
Global Alliance for Regenerative Medicine
Investigators
Study Director: Robert W Alexander, MD GARM-USA
Principal Investigator: Ken Williams, DO IIMSC

Publications:
Alexander, R.W., Understanding Adipose-Derived Stromal Vascular Fraction (AD-SVF) Cell Biology and Use on The Basis of Cellular, Chemical, and Paracrine Components. J of Prolo (2012), e855-869

Responsible Party: Ryan Welter, MD, PhD, Principal Investigator, Regeneris Medical
ClinicalTrials.gov Identifier: NCT03078686     History of Changes
Other Study ID Numbers: SAAA-GARM 1
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ryan Welter, MD, PhD, Regeneris Medical:
Stem Cells,PRP, tSVF,cSVF,Alopecia Areata,Scarring Alopecia

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Cicatrix
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Fibrosis
Pathologic Processes