Biocellular-Cellular Regenerative Treatment Scaring Alopecia and Alopecia Areata

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Brief Title

Biocellular-Cellular Regenerative Treatment Scaring Alopecia and Alopecia Areata

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)

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.
    

Detailed Description

      The aesthetic surgical & cosmetic discipline of hair restoration is rooted in numerous
      landmark studies and progressive medical science in the medical literature. With the advent
      of advanced theories and science using cellular and platelet-derived growth factors within
      the scope of regenerative medicine, have been well established in a number of peer-reviewed
      publications, The use of biological modalities, e.g., HD-PRP concentrates (defined as > 4-6
      times patient circulating baselines), have become recognized in a number of disciplines,
      including value of stimulation of scalp tissues and hair follicles in androgenetic alopecia
      (AGA). (See Clinical Trial Study STRAAND). A "retrograde" filling technique creating a
      potential space and subsequently injecting into this space will insure uniformity of
      placement and spread of the delivered treatment modality.

      This study design is intended to be a prospective, randomized, multi-center trial with
      blinding of outcomes for independent observers, clinical provider, and patient
      observation/satisfaction study comparatives. The study proposes adipose-derived cellular and
      stromal components when mixed with platelet high density concentrates (HD-PRP) offers an
      advantage to produce a markedly more effective therapeutic profile in in treating patients
      with scaring alopecia's (SA) and alopecia areata (AA), tissue age related senescence, and
      encourage vascular capabilities by stimulation of vasculoneogenesis. The benefits of using
      autologous adipose-derived stem & stromal cell (ADSC) populations are cell proliferation and
      vasculogenesis that is intrinsically linked with native inflammatory modulation and
      immunomodulatory capacities. Reports describing the safety and efficacy of this biocellular
      combination have been reported in peer reviewed literature.

      In the second and third arms of this study, use of regenerative protocols currently being
      extensively been utilized in the treatment of degenerative musculoskeletal conditions and
      plastic surgical procedures have been safely and effectively employed. These protocols
      feature the use of an emulsified AD-tSVF + HD PRP (ARM 2) compared to use of emulsified
      AD-tSVF + AD-cSVF (cell enrichment) + HD PRP (ARM 3) containing the full heterogeneous
      stem/stromal cell population and its native bioactive matrix. Addressing regions of scalp
      dermis containing the microenvironment (niche) of the hair follicle, progenitor tissues
      ("bulge").

      In ARM 3, addition of cellular enrichment of the emulsified AD-tSVF is accomplished via a
      semi-automated, closed sterile system (Healeon CentriCyte 1000 system) which effectively
      isolates and concentrate the cellular elements. The AD-cSVF is then mixed with high-density
      platelet rich plasma (HD-PRP) concentrates with emulsified AD-tSVF tissues prior to targeted
      scalp injections. This injected cell-enriched product contains the bioactive native adipose
      tissue scaffolding, autologous HD-PRP, and cell-enriched adipose stem/stromal cellular
      concentrations of stromal/stem cells.

      In ARM 4 of this study, the addition of intravenous cellular deployment of isolated cSVF is
      performed following without direct injection to scalp sites. Observations in other trials
      have suggested that increased hair growth in shaft size, coloration and speed is noted in the
      majority of parenterally treated patients as an observed effect of infusions. In the future,
      clinical trial extension of this study will combine both the components shown in ARM 3 and
      add a concomitant ARM 4 to evaluate potential of stimulation of proliferative and
      regenerative potentials in the form of combined therapy.

      It has been noted by several investigators that parenteral us of AD-cSVF has had an
      unexpected outcome of improve hair growth and color change. All of the study ARMs (with
      exception of comparative control ARM 1) are tested by flow cytometry for viabilities and
      numbers, which will be statistically compared to outcomes following the study completion to
      examine whether a statistically significant difference in results follows with each ARM can
      be shown.

      The goal of this study is to demonstrate the safety and efficacy of each ARM. Biocellular
      injections into the scalp of men and women with a diagnosis of scaring alopecias and alopecia
      areata, with full reporting of AE and SAE (adverse events). In the intradermal injection
      portions of the study, the biocellular material is injected 3-5 mm in depth within the
      mid-reticular dermis to upper subcutaneous fat layer of the scalp. Placement of the
      biocellular and cell-enriched biocelluar is intended to examine changes associated with
      changes of the miniaturized hair follicle. It is hypothesized that delivery a milieu of
      stroma and stem/stromal cells will facilitate regenerative changes of the treatment sites. In
      addition to providing native bioactive tissue scaffolding, and a greater number of
      stromal/stem cells to the tissues surrounding the follicular niche will result in a positive
      effect.

      Use of small needles for delivery is made possible with incorporating the novel use of
      emulsification of adipose tissue complex (lipoaspirates) This emulsified AD-tSVF and HD PRP
      methodology reduces surgeon injection pressure requirements resulting with use of smaller
      gauge needles. When clinically compared to the use of much larger needles required to inject
      non-emulsified AD-tSVF, it is an improvement on current techniques. A "retrograde" filling
      technique creating a potential space and subsequently injecting into this space the
      biocellular material as the needle is withdrawn is advanced in this study.

      Successful stem/stromal cell-enrichment of AD-tSVF and HD PRP biocellular mixture has been
      reported in numerous peer-reviewed and published clinical experiences of injections for
      structural tissue augmentation in plastic surgery, chronic wound therapies, and ultrasound
      guided musculoskeletal treatments in orthopedic & sports medicine.

      Standard venipuncture for obtaining circulating whole blood is concentrating platelet
      components to create a low hematocrit HD-PRP using FDA approved E USA) Emcyte II following
      manufacturer's guidelines. Small volume closed syringe microcannula lipoaspiration is used to
      acquire AD-tSVF tissues(Tulip Medical GEMS, San Diego, CA,, followed by emulsification via
      the Healeon ACM System (Newbury Beach, CA, USA. Cellular testing of samples in Arm 2-4 will
      be performed by flow cytometry (ORFLO, MoxiFlow, Ketchum, ID, USA) for viability and cell
      concentrations.

      A detailed patient medical history, study informed consent, and screening evaluations will
      determine eligibility and candidacy for the study and complying with the inclusion/exclusion
      criteria.

      Recording of the platelet pre-operative measured baselines and achieved HD PRP concentrates,
      flow cytometric examination of cell viability, and cell counts of AD-cSVF should be completed
      on each patient. Biocellular injections and treatment will be given on two (2) separate
      procedures three (3) months apart. Follow up clinical examinations are to be performed at 6
      months and 1 year period with completion of outcomes analyses including independent observer,
      clinician, and subject satisfaction. The volume of the therapueutic mix will be the
      standardized in volume for all trial ARMs.

      Immediate reporting to the study group for all AR and SAR will be documented and recorded for
      the safety records directly to Ken Williams, DO, as Co-Principal Investigator. This Clinical
      Trial will have a sample size of 60 patients at up to six (6) centers utilizing this
      protocol.
    


Study Type

Interventional


Primary Outcome

Safety of Intervention

Secondary Outcome

 Hair Growth Assessment

Condition

Alopecia Areata

Intervention

tSVF by lipoaspiration

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

60

Start Date

February 17, 2017

Completion Date

June 22, 2025

Primary Completion Date

January 22, 2025

Eligibility 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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Robert W Alexander, MD, 508.345.5492, [email protected]al.com

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03078686

Organization ID

SAAA-GARM 1


Responsible Party

Principal Investigator

Study Sponsor

Regeneris Medical

Collaborators

 Global Alliance for Regenerative Medicine

Study Sponsor

Robert W Alexander, MD, Study Director, GARM-USA


Verification Date

April 2020