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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Safety of Intervention
研究概览
简要总结
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.
详细描述
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.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
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 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.
- •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.
- •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
结局指标
主要结局
Safety of Intervention
时间窗: 6 months
Assess Adverse Events \& Severe Adverse Events
次要结局
- Photographic Assessment Scalp Hair(12 months)
- Hair Growth Assessment(12 months)
- Investigator Satisfaction Survey(12 months)
- Patient Satisfaction Outcome Survey(12 months)
研究者
Ryan Welter, MD, PhD
Principal Investigator
Regeneris Medical