FIG 1. denovo human hairfollicle INVITROHAIR PCT filed, with confirmed properties (dermal papila, hair matrix, outer and inner root sheath) 

“Initially we had no intention to replicate hair, because we were hesitant to participate in an industry facing a lot of criticism from all scientific fields for raising patient expectations and then not being able to deliver satisfactory results.”

“Various conducted stainings of our prototypes confirmed that INVTROHAIR patent protected and produced a fully formed -entirely- human hairfollicle with the potential for being transplanted into the human scalp, bringing total disruption to the hairtransplant and haircosmetics industry. However, given the world wide  prevalence of ALOPECIA we see it as our mission to support scientific and clinician colleagues with our invention as it‘s evident that the entire field can’t be covered by one single company“.

Up today there is a variety of methods for tissue fabrication for multiple tissue types (Patentapplication US20170130192A1; Patent application US6096347A; Patent JP5893786B2; Patentapplication WO2017077985A1).

Evidently, none of them successfully developed in vitro hair follicles, or tissue sheets containing hair follicles, or integrate biodegradable material scaffolds for aiding the generation of asymmetry in the structure of said tissue sheets or in the shafts of said hair follicles.

The lack of bioengineered hair follicles and hair follicle containing sheets with defined position of hair shafts, result in the use of natural sources for cosmetic surgeries, such us allogeneic donated human hair samples. Finally, the use of allogeneic material imposes immunological incompatibility. On the other hand, using autogenous stem cells to derive the aforementioned hair follicles results in a situation of autotransplantation, which eliminates the risk of immune activation and rejection of follicle implants.

Our invention describes a method for deriving hair follicles and sheets containing hairfollicles using autogenous sources, and can be implemented in good manufacturing procedures pipelines and xeno free conditions. Furthermore, using as source biodegradable grids containing and carrying said hair follicles, facilitates the downstream surgical process by augmenting the hair follicle count used and handled per surgical step.

Nevertheless we must conduct our work as accurate and as precise as possible. This requires time and detailed analysis of the patients pathogenesis.

NON APPROVED STEMCELL THERAPIES

At INVITROHAIR we strictly campaign against the unethical and dangerous practice of non approved stemcell therapies and associated assays. Despite we produce patented bioengineered de novo human hairfollicles for transplantation and compound testing; we will implement, with the utmost scientific and technological rigor, procedures in absolute accordance with the respective governmental regulations.

Below we cite passages of a report in order to raise awareness and communicate our clear position against those unregulated procedures. All testing offers from aside our firm are related to the identification of patients specific pathology, within the use of all available high technology applications on the market. Under no circumstances we perform any unproven or dangerous procedures on patients or participants in clinical trials or compassionate use experiments. 


FIG. 2. Stem Cell Types and Conditions Marketed * Data from stem cell business websites were collected and analyzed for claims related to the use of (A) specific types of stem cells marketed for (B) a range of conditions. 


Many of these [unregulated stem cell clinics] marketing claims raise significant ethical issues given the lack of peer-reviewed evidence that advertised stem cell interventions are safe and efficacious for the treatment of particular diseases. Such promotional claims also generate regulatory concerns due to apparent noncompliance with federal regulations. 
One unanticipated interpretive challenge we encountered is that many businesses advertise both stem cell inter- ventions and platelet rich plasma (PRP) procedures either as the basis for separate treatments or as combination ‘‘cell therapies.’’ Though not an actual stem cell product, PRP is sometimes marketed as an autologous ‘‘stem cell treatment’’ derived from peripheral blood. In such cases, the rhetoric of ‘‘stem cells’’ is presumably used as a marketing hook intended to attract potential customers (Turner, 2015b). 

*Leigh Turner1,* and Paul Knoepfler2,3,*
1Center for Bioethics, School of Public Health, and College of Pharmacy, University of Minnesota, Minneapolis, MN 55455, USA 2Department of Cell Biology and Human Anatomy, University of California, Davis, Davis, CA 95616, USA 3Institute of Pediatric Regenerative Medicine, Shriners Hospital For Children Northern California, Sacramento, CA 95817, USA *Correspondence: turne462@umn.edu (L.T.), knoepfler@ucdavis.edu (P.K.) http://dx.doi.org/10.1016/j.stem.2016.06.007

INCIDENCE OF TYPE 2 DIABETES MELLITUS IN MEN RECEIVING STEROID 5α-REDUCTASE INHIBITORS LIKE DUTASTERIDE AND FINASTERIDE.

At INVITROHAIR we strictly oppose the unethical and dangerous practice of the prescription OEM labeled and custom produced steroid 5α-reductase inhibitors. Various studies showed correlative „incidences of type 2 diabetes mellitus in men receiving steroid 5α-reductase inhibitors.“

As it’s common practice in hair clinics to modify and sell relabeled Dutasteride and Finasteride compounds - supplied by contract pharmacies- unfortunately, the associated risk of development of Type II Diabetes Mellitus is not emphasized and researched in an appropriate manner.

A recent short term experimental medicine study showed that dutasteride induces insulin resistance -a major risk factor for type 2 diabetes- however, neither finasteride nor the α blocker tamsulosin had this effect. Moreover, dutasteride administered for three weeks promotes hepatic steatosis, although this result was not found for finasteride. Traish and colleagues reported increased blood glucose and glycated haemoglobin A1c after approximately three years of dutasteride treatment, but did not assess the effect of finasteride. These findings are consistent with increased susceptibility to diet induced obesity, impaired glucose tolerance, and fatty liver reported inSrd5a1-/- mice; similar changes were found in obese rats receiving dual 5α-reductase inhibitors.

The results of the study are alarming and are showcasing perfectly that the repurpose and modifications of chemical compounds and molecules are a dead end for sustainable Alopecia treatments, however it potentially could make clinical applications and studies on the efficacy, dosage and therapies of steroid 5α-reductase inhibitors obsolete.

The study results and concludes further, that of „ total of 69794 patients received at least two prescriptions of dutasteride, finasteride, or tamsulosin (fig 1). After we applied exclusions, 55 275 participants remained; 39 005 patients using 5α-reductase inhibitors were included (8231 dutasteride and 30 774 finasteride) and 16270 receiving tamsulosin. At baseline, patients receiving dutasteride or finasteride were older, had more comorbidities, except for dyslipidaemia, and used more oral corticosteroids and cardiovascular drugs than those receiving tamsulosin ... There were fewer differences in baseline characteristics between the dutasteride and finasteride groups, with no differences in body mass index. When we included patients receiving dutasteride combined with tamsulosin or finasteride combined with tamsulosin the numbers increased by 599 and 2622, respectively [......] Men using steroid 5α-reductase inhibitors [.....] appear to be at a modest increased risk of developing type 2 diabetes. […] the decision to prescribe 5α-reductase inhibitors for men with metabolic disease must be considered carefully in the context of other risk factors for type 2 diabetes.“


*Fig 2 | Cumulative incidence of type 2 diabetes in Clinical Practice Research Datalink cohort over study period: main cohort (adjusted), and adjusted for propensity score


At INVITROHAIR 털의 Ltd. we believe that-  with  introducing the study named : „Incidence of type 2 diabetes mellitus in men receiving steroid 5α-reductase inhibitors [Dutasteride/Finasteride]: population based cohort study“, by Li Wei, Edward Chia-Cheng Lai, Yea-Huei Kao-Yang,Brian R Walker, Thomas M MacDonald, Ruth Andrew - which is  indicating a clear correlation between Dutasteride/Finasteride and Diabetes Mellitus Type II - we have sustainable solutions in regards to regenerative medicine and tissue engineering for transplantation of our HAIROID™️ PATENTS into the patients scalp. With prevalence calculations on  Alopecia ranging from 18% to 50,1% of the worldwide (female/male) population [Male Androgenetic Alopecia: Population-Based Study in 1,005 Subjects DS Krupa Shankar et.al; Study of the International Epidemiology of Androgenetic Alopecia in Young Caucasian Men Using Photographs From the Internet, Yaniv Shalom et.al] INVITROHAIR 털의 Ltd. has the potential to spearhead a untamed and indefinite big market and to treat various patient-populations.