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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02849470|
Recruitment Status : Enrolling by invitation
First Posted : July 29, 2016
Last Update Posted : August 3, 2022
|First Submitted Date ICMJE||July 27, 2016|
|First Posted Date ICMJE||July 29, 2016|
|Last Update Posted Date||August 3, 2022|
|Actual Study Start Date ICMJE||August 14, 2016|
|Estimated Primary Completion Date||July 31, 2024 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Safety-Tolerability Assess of SAE/AE Assessment of SAE/AES [ Time Frame: 6 months ]
Safety-Tolerability Assess of SAE/AE
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||AGA Biocellular Stem/Stromal Hair Regenerative Study|
|Official Title ICMJE||Biocellular Regenerative Therapy in Hair Loss: Use of High Density Platelet-Rich Plasma Concentrates and Cell-Enriched Emulsified Adipose-Derived Tissue Stromal Vascular Fraction|
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).
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
The cosmetic discipline of hair restoration is rooted in numerous landmark studies and progressive medical science in the medical literature. , , , , With the advent of advance theories and science within the scope of regenerative medicine, numerous reports are noted in the literature. , , , , , using biological modalities, e.g., HD-PRP concentrates defined as > 4-6 times patient circulating baselines, for stimulation of scalp tissues and hair follicles in androgenetic alopecic (AGA).
Design of this study is intended to be a prospective, randomized, multicenter trial with blinding of outcomes for independent observer, clinical provider and patient observation/satisfaction studies. The study proposes adipose-derived (AD) biocellular material when mixed with platelet high density concentrates (HD-PRP) offers a potential advantage for a markedly more effective therapeutic profile in areas of follicular miniaturization, tissue age related senescence, and effect the decreased vascular capabilities by stimulation of vasculoneogenesis. The benefits of using autologous adipose-derived stem/stromal cell (ADSCs) populations are cell proliferation and vasculogenesis that is intrinsically linked with native immunomodulatory capacities. Reports describing the safety and efficacy of this biocellular combination have been reported in peer reviewed literature. , In the second and third arm of this study, the use of regenerative protocols currently being utilized in the treatment of degenerative musculoskeletal conditions is employed. These protocols feature the use of an emulsified AD-tSVF and emulsified cell enriched AD-cSVF containing the full heterogeneous stem/stromal cell population and matrix that is injected into the regions of scalp containing the microenvironment (niche) of the hair follicle. In Arm 3, cellular enrichment of the emulsified AD-tSVF is accomplished via a semi-automated, closed sterile system (Healeon CentriCyte 1000 system) to isolate and concentrate AD-cSVF. The AD-cSVF is then mixed with high-density platelet rich plasma (HD-PRP) concentrates and emulsified AD-tSVF tissues (AD-tSVF) prior to scalp injection. This injected cell-enriched product contains native adipose tissue scaffolding, autologous HD-PRP, and enriched adipose stem/stromal cell-enriched concentration of stromal/stem cells (AD-cSVF).
The goal of this study is to demonstrate the safety and efficacy of the HD-PRP + AD-tSVF + AD-cSVF biocellular injections into the scalp of men and women with a diagnosis of non-scaring alopecias, with full reporting of AE and SAE (adverse events). The biocellular material is injected 3-5 mm in depth within the mid-reticular dermis to upper subcutaneous fat layer of the scalp for the purpose of regenerating the miniaturized hair follicle, and delivering a milieu of stromal/stem cells that facilitate regenerative changes within the tissue sites. In addition to providing tissue scaffolding, and a greater number of stromal/stem cells to the tissues surrounding the follicular niche, the novel use and emulsification of AD tissues with cell-enriched biocellular material permits ergonomic facilitation of layered injection patterns in the scalp with small gauge (25-27 gauge) needles This emulsified AD Biocellular methodology reduces injection pressure requirements using 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.
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 surgery. 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.
All patients will undergo venipuncture for obtaining HD-PRP concentrates following FDA approved Emcyte II manufacturer's guidelines. Those patients having biocellular treatment with also undergo a small volume closed syringe microcannula lipoaspiration to acquire AD-tSVF tissues, which will be emulsified via the Healeon ACM System per manufacturer's guidelines. Cellular testing of samples in Arm 2 and Arm 3 will be performed by flow cytometry (ORFLO, MoxiFlow, Ketchum, ID, USA) for viability and cell concentrations. The trial will include the biocellular mixture of HD-PRP + emulsified AD-tSVF (Arm 2) and/or, HD-PRP + emulsified AD-tSVF + AD-cSVF (Arm 3). Study will utilize a standardized high-density PRP concentration system on all patients in the same volume. The definition of HD-PRP concentrates is a minimum =/>4 times patient circulating platelet counts.
A detailed patient medical history, informed consent, and screening evaluation will determine eligibility and candidacy for the study. Each patient will undergo a small volume lipoaspiration (defined as <100 cc) under local anesthesia with, or without, oral sedation. Candidates will be assigned to one of three treatment ARMs. The treatment ARMS are: ARM 1: HD-PRP + Matristem Matrix (A-Cell) (control); ARM 2: HD-PRP + emulsified AD-tSVF; and, ARM 3: HD-PRP + emulsified AD-tSVF + cell-enriched AD-cSVF. All patients will receive a standard ring block local anesthesia of the scalp treatment areas, followed by retrograde injection pattern of the biocellular material.
Recording of the platelet baseline and treatment concentrates, flow cytometric examination of cell viability, and cell counts of AD-cSVF will 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 1year period with completion of outcomes analyses including independent observer, clinician, and subject satisfaction. The volume of the HD-PRP concentrates 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 Principal Clinical Investigator. This Clinical Trial will have a sample size of 60 patients at up to six (6) centers utilizing the same protocols, equipment and reporting requirements.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 1
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Hair Disease|
|Study Arms ICMJE||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Enrolling by invitation|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||July 31, 2025|
|Estimated Primary Completion Date||July 31, 2024 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT02849470|
|Other Study ID Numbers ICMJE||GARM 6.1.16|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Current Responsible Party||Healeon Medical Inc|
|Original Responsible Party||Robert W. Alexander, MD, FICS, Healeon Medical Inc, Principal Investigator, Science|
|Current Study Sponsor ICMJE||Healeon Medical Inc|
|Original Study Sponsor ICMJE||Same as current|
|PRS Account||Healeon Medical Inc|
|Verification Date||August 2022|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP