Biocellular Regenerative Therapy in Hair Loss: Use of High Density Platelet-Rich Plasma Concentrates and Cell-Enriched Emulsified Adipose-Derived Tissue Stromal Vascular Fraction
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Safety-Tolerability Assess of SAE/AE Assessment of SAE/AES
研究概览
简要总结
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
- HD-PRP + Matristem Matrix (ACell)
- Experimental: HD-PRP + Emulsified AD-tSVF
- 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
详细描述
Detailed Description:
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Males with a diagnosis of Androgenetic Alopecia (AGA).
- •Females with a biopsy proven diagnosis of Female Pattern Hair Loss (FPHL) excluding scaring or autoimmune disorders.
- •Males with hair loss consistent with Grades II, III, IIIA, III-Vertex, IV, IV-A, based on Norwood-Hamilton Scale.
- •Females with hair loss consistent with Grades I-3, I-4, II-1, II-2 based on the Savin Scale.
- •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
排除标准
- •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 previous hair transplant, PRP, biocellular treatments, micro needling, cold laser therapies, or any other scalp or hair loss treatment.
- •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.).
- •History of or active diagnosis of 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.
- •Active systemic infection at the time of enrollment. If acquired afterwards, exclusion based on clinical judgment of investigator.
- •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.
- •Employees or family members of the study staff.
- •Untreated or uncontrolled thyroid disorder (abnormal TSH/free T4) or diabetes mellitus (HgbA1C > 8.0).
- •Subject who has a sensitive, irritated, or abraded scalp area.
- •Women who have an alternate diagnosis that is associated with hair loss.
- •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:
结局指标
主要结局
Safety-Tolerability Assess of SAE/AE Assessment of SAE/AES
时间窗: 6 months
Safety-Tolerability Assess of SAE/AE
次要结局
- Hair Growth Trichogram(12 Months)
- Hair Investigator Satisfaction(12 Months)
- Hair Density Trichogram(12 Months)
- Global Photometric Scalp Hair(12 Months)
- Patient Satisfaction Survey(12 Months)