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AGA Biocellular Stem/Stromal Hair Regenerative Study (STRAAND)

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: NCT02849470
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : November 7, 2019
Sponsor:
Collaborators:
Ministry of Health, Honduras
Robert W. Alexander, MD
Terry, Glenn C., M.D.
Information provided by (Responsible Party):
Healeon Medical Inc

Brief Summary:

Purpose 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) as compared with adipose-derived cell-enriched SVF (AD-cSVF) + AD-tSVF and HD- PRP concentrates in treatment of androgenetic alopecia (AGA) and Female Pattern Hair Loss (FPHL).

Assigned Interventions

  1. HD-PRP + Matristem Matrix (ACell)
  2. Experimental: HD-PRP + Emulsified AD-tSVF
  3. Experimental: HD- PRP + Emulsified AD-tSVF + Emulsified AD-cSVF Device: Tulip Microcannula Closed Syringe For All Lipoaspiration (2.11 mm Diameter, offset Carraway) Centrifugation technique to acquire concentrated platelets (per manufacturer's approved protocol) Healeon ACM Emulsification System that prepares microcannula harvested AD-tSVF for small needle (25g) retrograde threaded intradermal scalp injection.

Healeon Centricyte 1000 system for cellular isolation of AD-cSVF from AD-tSVF and testing by Flow Cytometry (ORFLO MoxiFlow) Procedure: Closed syringe microcannula lipoaspiration (AD-tSVF) Procedure: Emulsification of AD-tSVF via Healeon ACM Protocol (Newbury Park, CA, USA) Procedure: Biocellular mix of emulsified AD-tSVF and HD-PRP for intradermal injection in scalp; (Arm 2) Procedure: Cellular isolation (AD-cSVF) Centricyte 1000 incubation/shaker system using GMP certified, sterile Liberase MNP-S (Roche #06297790001) for enzymatic digestion manufacturer standard protocol. Creation of emulsified AD-tSVF + PRP + cell-enriched AD-cSVF for intradermal injection in scalp (Arm 3) Sham Comparator: No Fat Control using Emcyte II PRP Concentrate + Matristem (Acell) for subcutaneous scalp injection patterned per square centimeter of scalp. Procedure: Emcyte Pure PRP® II system to concentrate Platelets via using manufacturer standard protocol


Condition or disease Intervention/treatment Phase
Hair Disease Procedure: Intradermal Injection in hair loss Procedure: Platelet Rich Plasma Procedure: Adipose Derived Stem/Stromal Cells Procedure: Stem/Stromal Cellular Isolation (Digestive) Procedure: MatriStem Matrix (ACell) - Current Standard of Care Procedure: HD-PRP (High Density Platelet Rich Plasma) Procedure: Emulsified AD-tSVF Procedure: Emulsified AD-cSVF Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biocellular Regenerative Therapy in Hair Loss: Use of High Density Platelet-Rich Plasma Concentrates and Cell-Enriched Emulsified Adipose-Derived Tissue Stromal Vascular Fraction
Actual Study Start Date : August 14, 2016
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hair Problems

Arm Intervention/treatment
Active Comparator: ARM 1
Control: 1) HD-PRP + Matristem Matrix (ACell) (Current Standard of Care); 2) Intradermal injections of hair loss 3) Platelet Rich Plasma 4) Matristem Matrix (ACell)
Procedure: Intradermal Injection in hair loss
Comparative Injection of Control (PRP & Acel) in hair loss; 2) Intradermal Injection in hair loss
Other Names:
  • ARM 1
  • Matricell (ACell)
  • Platelet Rich Plasma

Procedure: Platelet Rich Plasma
Growth factors and cytokines to promote healing and vascular supply
Other Name: ARM 1, ARM 2, ARM 3

Procedure: MatriStem Matrix (ACell) - Current Standard of Care
Procedure: HD-PRP (High Density Platelet Rich Plasma)
Active Comparator: ARM 2
  1. Experimental: HD-PRP + Emulsified AD-tSVF;

    Intervention:

  2. Platelet Rich Plasma
  3. Adipose Derived Stem/Stromal Cells
  4. Intradermal injections of hair loss
Procedure: Intradermal Injection in hair loss
Comparative Injection of Control (PRP & Acel) in hair loss; 2) Intradermal Injection in hair loss
Other Names:
  • ARM 1
  • Matricell (ACell)
  • Platelet Rich Plasma

Procedure: Platelet Rich Plasma
Growth factors and cytokines to promote healing and vascular supply
Other Name: ARM 1, ARM 2, ARM 3

Procedure: Adipose Derived Stem/Stromal Cells
Harvesting Adipose Lipoaspirate with Microcannula System
Other Names:
  • ARM 2 and ARM 3
  • Platelet Rich Plasma
  • Emulsification of Adipose Derived tSVF
  • Intradermal Injection in hair loss

Procedure: HD-PRP (High Density Platelet Rich Plasma)
Procedure: Emulsified AD-tSVF
Experimental: ARM 3

Experimental: HD- PRP + Emulsified AD-tSVF + Emulsified AD-cSVF; Intervention: Intradermal injections of hair loss

  1. Platelet Rich Plasma
  2. Adipose Derived Stem/Stromal Cells
  3. Stem/Stromal Cell Isolation
  4. Intradermal injections of hair loss
Procedure: Intradermal Injection in hair loss
Comparative Injection of Control (PRP & Acel) in hair loss; 2) Intradermal Injection in hair loss
Other Names:
  • ARM 1
  • Matricell (ACell)
  • Platelet Rich Plasma

Procedure: Platelet Rich Plasma
Growth factors and cytokines to promote healing and vascular supply
Other Name: ARM 1, ARM 2, ARM 3

Procedure: Adipose Derived Stem/Stromal Cells
Harvesting Adipose Lipoaspirate with Microcannula System
Other Names:
  • ARM 2 and ARM 3
  • Platelet Rich Plasma
  • Emulsification of Adipose Derived tSVF
  • Intradermal Injection in hair loss

Procedure: Stem/Stromal Cellular Isolation (Digestive)
Cell isolation and concentration add back to AD-stem/stromal cells utilizing Centricyte 1000 Protocol
Other Names:
  • ARM 3
  • Platelet Rich Plasma
  • Emulsification of Adipose Derived cSVF
  • Intradermal injection in hair loss

Procedure: HD-PRP (High Density Platelet Rich Plasma)
Procedure: Emulsified AD-tSVF
Procedure: Emulsified AD-cSVF
Stem/Stromal Cellular Isolate Added Back to Emulsified AD-tSVF




Primary Outcome Measures :
  1. Safety-Tolerability Assess of SAE/AE Assessment of SAE/AES [ Time Frame: 6 months ]
    Safety-Tolerability Assess of SAE/AE


Secondary Outcome Measures :
  1. Hair Growth Trichogram [ Time Frame: 12 Months ]
    Growth Assessment by Trichogram [ Designated as safety issue: No ] Assessment by Trichogram

  2. Hair Density Trichogram [ Time Frame: 12 Months ]
    Hair Density Assessment Trichogram [ Designated as safety issue: No ] Assessment by Trichogram

  3. Global Photometric Scalp Hair [ Time Frame: 12 Months ]
    Global Photographic assessment scalp hair Photographic assessment of scalp hair by independent observer

  4. Hair Investigator Satisfaction [ Time Frame: 12 Months ]
    Hair Investigator Satisfaction Survey [ Designated as safety issue: No ] Assessment of treatment outcome by treating physician

  5. Patient Satisfaction Survey [ Time Frame: 12 Months ]
    Patient Satisfaction Survey [Designated as safety issue: No] Assessment of treatment Outcomes by patient.



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inclusion Criteria:

    1. Males with a diagnosis of Androgenetic Alopecia (AGA).
    2. Females with a biopsy proven diagnosis of Female Pattern Hair Loss (FPHL) excluding scaring or autoimmune disorders.
    3. Males with hair loss consistent with Grades II, III, IIIA, III-Vertex, IV, IV-A, based on Norwood-Hamilton Scale.
    4. Females with hair loss consistent with Grades I-3, I-4, II-1, II-2 based on the Savin Scale.
    5. Demonstrated ability to legally provide written informed consent and comply with the study requirements
    6. 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
    7. Subject is willing to maintain existing and consistent hair length and color.
    8. Ability to complete study procedures, patient surveys, and photodocumentation.
    9. Subject is ≥ 18 years of age.
    10. 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 previous hair transplant, PRP, biocellular treatments, micro needling, cold laser therapies, or any other scalp or hair loss treatment.
  5. Subject with previously diagnosed or suspected of having active scaring alopecia, autoimmune diseases such as serum lupus erythematosus, or alopecia areata; unspecified dermatologic condition, or disorders that will make hair growth difficult (such as systemic burns, etc.).
  6. History of or active diagnosis of 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. Women who have an alternate diagnosis that is associated with hair loss.
  21. Clinically significant abnormal findings on laboratory screening panels:

    • Hemoglobin ≤ 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.
    • An elevated PT/PTT, INR,
    • platelet count < 100 x 109/L

Exclusion Criteria:

-


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): NCT02849470


Contacts
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Contact: Kenneth Williams, DO 949-333-2999 drwilliams@iimcs.org
Contact: Robert W. Alexander, MD 406.777.5312 rwamd@cybernet1.com

Locations
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United States, California
Kenneth Williams, DO Recruiting
Irvine, California, United States, 92618
Sponsors and Collaborators
Healeon Medical Inc
Ministry of Health, Honduras
Robert W. Alexander, MD
Terry, Glenn C., M.D.
Investigators
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Study Director: Ryan Welter, MD, PhD, MD,PhD Regeneris
Study Director: Marco Barusco, MD Brusco Clinic
Principal Investigator: Kenneth Williams, DO Irvine Institute Medicine & Cosmetic Surgery

Publications:
Understanding Adipose-derived Stromal Vascular Fraction (AD-SVF) Cell Biology and Use on the Basis of Cellular, Chemical, Structural and Paracrine Components: A Concise Review
Alexander, R. Use of Disposable Microcannula System For Low Pressure, Preparation, and Placement of Small Volume Autologous Fat Grafting With Activated High-Density Platelet Rich Plasma (HD-PRP). Clin, Cosm, Investig Derm. 2013; 6: 91-102.
Understanding Mechanical Emulsification (Nanofat) Versus Enzymatic Isolation of Tissue Stromal Vascular Fraction (tSVF) Cells from Adipose Tissue: Potential Uses in Biocellular Regenerative Medicine
Zuk, P., Adipose-Derived Stem Cells in Tissue Regeneration. Review, Hindawi Publlishing Coripration, ISRN Stem Cells, Volume 2013, Artilce ID 713959, http://dx.doi.org/10.1155/2013/713959

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Responsible Party: Healeon Medical Inc
ClinicalTrials.gov Identifier: NCT02849470     History of Changes
Other Study ID Numbers: GARM 6.1.16
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Healeon Medical Inc:
Adipose Stem/Stromal Cells
PRP
SVF
Cell Therapy
Alopecia
GF
Additional relevant MeSH terms:
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Hair Diseases
Skin Diseases
Complement Factor H
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs