Biocellular-Cellular Regenerative Treatment Scaring Alopecia and Alopecia Areata

NCT03078686 | Unknown DMC

• 1 other identifier: SAAA-GARM 1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Alopecia Areata; Scarring Alopecia

Keywords

Stem Cells,PRP, tSVF,cSVF,Alopecia Areata,Scarring Alopecia

Outcome Measures

Primary Outcomes (1)

• Safety of Intervention

  Assess Adverse Events \& Severe Adverse Events

  6 months

Secondary Outcomes (4)

• Hair Growth Assessment

  12 months

• Photographic Assessment Scalp Hair

  12 months

• Investigator Satisfaction Survey

  12 months

• Patient Satisfaction Outcome Survey

  12 months

Study Arms (4)

Control ARM 1

ACTIVE COMPARATOR

Control: 1) HD-PRP + Matristem Matrix (ACell) (Current Standard of Care); 2) Platelet Rich Plasma Concentrate)

Procedure: PRP Concentration

Emulsification tSVF + PRP ARM 2

EXPERIMENTAL

HD-PRP + Emulsified AD-tSVF; Intervention: Platelet Rich Plasma Concentrate

Procedure: tSVF by lipoaspiration; Procedure: PRP Concentration; Procedure: Emulsification tSVF

Emulsification tSVF + PRP + cSVF ARM 3

EXPERIMENTAL

tSVF; PRP; cSVF cell enriched biocellular therapeutic mix

Procedure: tSVF by lipoaspiration; Procedure: PRP Concentration; Procedure: Emulsification tSVF; Procedure: cSVF isolation and concentration

cSVF in Normal Saline IV ARM 4

EXPERIMENTAL

cSVF + Normal Saline IV (500 cc) Infusion

Procedure: tSVF by lipoaspiration; Procedure: cSVF isolation and concentration; Procedure: cSVF in Normal Saline IV

Interventions

tSVF by lipoaspiration PROCEDURE

Lipoaspiration Harvest tSVF closed syringe microcannula harvest, Tulip GEMS microcannula syringe system

Emulsification tSVF + PRP + cSVF ARM 3; Emulsification tSVF + PRP ARM 2; cSVF in Normal Saline IV ARM 4

PRP Concentration PROCEDURE

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

Control ARM 1; Emulsification tSVF + PRP + cSVF ARM 3; Emulsification tSVF + PRP ARM 2

Emulsification tSVF PROCEDURE

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

Emulsification tSVF + PRP + cSVF ARM 3; Emulsification tSVF + PRP ARM 2

cSVF isolation and concentration PROCEDURE

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

Emulsification tSVF + PRP + cSVF ARM 3; cSVF in Normal Saline IV ARM 4

cSVF in Normal Saline IV PROCEDURE

cSVF + NS for IV Placement

cSVF in Normal Saline IV ARM 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males with a biopsy proven diagnosis of a Scaring alopecia (SA) or Alopecia Areata (AA)
• Females with a biopsy proven diagnosis of Scaring alopecia (SA) or Alopecia Areata (AA)
• 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 recent PRP, biocellular treatments, micro needling, cold laser therapies, or any other scalp or hair loss treatment.
• Subject with previously diagnosed or suspected unspecified dermatologic condition, or disorders that will make hair growth difficult (such as systemic burns, etc.).
• History of or active diagnosis of systemic 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

• Regeneris Medical: lead
• Global Alliance for Regenerative Medicine: collaborator

Study Sites (3)

Kenneth Williams, DO

Irvine, California, 92618, United States

RECRUITING

Regeneris Medical

North Attleboro, Massachusetts, 02760, United States

RECRUITING

Regenevita LLC

Stevensville, Montana, 59870, United States

RECRUITING

Related Publications (13)

• Alexander RW. Biocellular Regenerative Medicine: Use of Adipose-Derived Stem/Stromal Cells and It's Native Bioactive Matrix. Phys Med Rehabil Clin N Am. 2016 Nov;27(4):871-891. doi: 10.1016/j.pmr.2016.06.005.

  PMID: 27788905 BACKGROUND

• Li MD, Atkins H, Bubela T. The global landscape of stem cell clinical trials. Regen Med. 2014 Jan;9(1):27-39. doi: 10.2217/rme.13.80. Epub 2013 Nov 18.

  PMID: 24236476 BACKGROUND

• Hoareau L, Bencharif K, Girard AC, Gence L, Delarue P, Hulard O, Festy F, Roche R. Effect of centrifugation and washing on adipose graft viability: a new method to improve graft efficiency. J Plast Reconstr Aesthet Surg. 2013 May;66(5):712-9. doi: 10.1016/j.bjps.2012.12.033. Epub 2013 Jan 26.

  PMID: 23357708 BACKGROUND

• Conde-Green A, de Amorim NF, Pitanguy I. Influence of decantation, washing and centrifugation on adipocyte and mesenchymal stem cell content of aspirated adipose tissue: a comparative study. J Plast Reconstr Aesthet Surg. 2010 Aug;63(8):1375-81. doi: 10.1016/j.bjps.2009.07.018. Epub 2009 Aug 12.

  PMID: 19679523 BACKGROUND

• Kurita M, Matsumoto D, Shigeura T, Sato K, Gonda K, Harii K, Yoshimura K. Influences of centrifugation on cells and tissues in liposuction aspirates: optimized centrifugation for lipotransfer and cell isolation. Plast Reconstr Surg. 2008 Mar;121(3):1033-1041. doi: 10.1097/01.prs.0000299384.53131.87.

  PMID: 18317153 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

• Koh YJ, Koh BI, Kim H, Joo HJ, Jin HK, Jeon J, Choi C, Lee DH, Chung JH, Cho CH, Park WS, Ryu JK, Suh JK, Koh GY. Stromal vascular fraction from adipose tissue forms profound vascular network through the dynamic reassembly of blood endothelial cells. Arterioscler Thromb Vasc Biol. 2011 May;31(5):1141-50. doi: 10.1161/ATVBAHA.110.218206. Epub 2011 Mar 10.

  PMID: 21393582 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

• Gentile P, Garcovich S, Bielli A, Scioli MG, Orlandi A, Cervelli V. The Effect of Platelet-Rich Plasma in Hair Regrowth: A Randomized Placebo-Controlled Trial. Stem Cells Transl Med. 2015 Nov;4(11):1317-23. doi: 10.5966/sctm.2015-0107. Epub 2015 Sep 23.

  PMID: 26400925 BACKGROUND

• Gentile P, Orlandi A, Scioli MG, Di Pasquali C, Bocchini I, Cervelli V. Concise review: adipose-derived stromal vascular fraction cells and platelet-rich plasma: basic and clinical implications for tissue engineering therapies in regenerative surgery. Stem Cells Transl Med. 2012 Mar;1(3):230-6. doi: 10.5966/sctm.2011-0054. Epub 2012 Feb 22.

  PMID: 23197782 BACKGROUND

• 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

  BACKGROUND

• Elmaadawi IH, Mohamed BM, Ibrahim ZAS, Abdou SM, El Attar YA, Youssef A, Shamloula MM, Taha A, Metwally HG, El Afandy MM, Salem ML. Stem cell therapy as a novel therapeutic intervention for resistant cases of alopecia areata and androgenetic alopecia. J Dermatolog Treat. 2018 Aug;29(5):431-440. doi: 10.1080/09546634.2016.1227419. Epub 2018 Mar 6.

  PMID: 27553744 BACKGROUND

• Aronowitz JA, Lockhart RA, Hakakian CS, Birnbaum ZE. Adipose Stromal Vascular Fraction Isolation: A Head-to-Head Comparison of 4 Cell Separation Systems #2. Ann Plast Surg. 2016 Sep;77(3):354-62. doi: 10.1097/SAP.0000000000000831.

  PMID: 27220016 BACKGROUND

MeSH Terms

Conditions

Alopecia Areata; Alopecia

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert W Alexander, MD

  GARM-USA

  STUDY DIRECTOR

• Ken Williams, DO

  IIMSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Welter, MD, PhD

CONTACT

508.345.5492; r.welter@regenerismedical.com

Ken Williams, DO

CONTACT

1.949.333.2999; drwilliams@iimsc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 13, 2017
• Study Start: February 17, 2017
• Primary Completion: January 22, 2025
• Study Completion: June 22, 2025
• Last Updated: April 16, 2020

Record last verified: 2020-04

Locations

US (3)