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October 23, 2017CANADA HAIRCELL CLINICAL PROTOCOLBackground:Hair loss, whether focal or effecting the entire scalp, is a major personal health problem for millions of people around the world. This condition has many causes, and effects people as young as their teenage years. There are many treatments on the market, but most are not based on very little if any science, and offer little benefit in most patients.HairCell is a totally scientifically proven approach that is based on use of a combination of non-invasive bioelectric signals to stimulate the scalp to turn on expression of local proteins that drive native stem cell Recruitment, Proliferation, and Differentiation to achieve local hair regeneration. In addition, all subjects will receive local delivery of amniotic fluid, which contains contains over 240 proteins that lead to development of all tissues and organs in the body, and is nature’s fluid that bathes developing babies in the womb. This is the first pure science-based approach to treat hair loss, and promises to be the most effective treatment ever developed.The study will randomize patients to this regimen alone, or to receive in addition, a Tesla Brush for home use. This brush has shown significant benefit to a number of patients with no adverse effects. It is approved by the Canadian regulatory authorities.Study Description: This is a prospective, non-randomized, open label, consecutive series study to evaluate the safety and feasibility of a series of treatments to the scalp of patients with hair loss. The treatment will include either bioelectric stimulation controlled protein expression and local delivery of amniotic fluid for the treatment to induce hair regeneration, or that treatment delivered in the clinic plus the use of the Tesla Brush at home.The study, including protocol and consent form, will have been approved without stipulations by a local or certified Institutional Review Board as meeting safe and good clinical practice before any subject will be enrolled.Target Number Enrolled: 30Number of Enrolling Sites: 1PROTOCOL:Inclusion Criteria: Age 18-60 yrs of age Subjects must be in good health with a BMI < 35. Must have one of three types of hair loss:A. Male pattern Baldness not due to chemotherapyB. Significant area of Hair ThinningC. Focal Alopecia of at least a 3cm x 3cm area on the scalp which shows evidence of hair loss without scarring or traumatic injury Willing to be present for the required treatment/study visits. Able and willing to give informed consent and follow study instructions and requirements. Must speak, read, and understand EnglishExclusion Criteria: Use of other treatments to improve hair growth, including topical medications, oral medications, meso-therapy, non-ablative fractional laser treatment, low-level laser therapy, inter-follicular PRP(Platelet Rich Plasma) injection, or hair transplantation within the preceding 3 months. History of bleeding disorder Current use of any anti-platelet or anticoagulant medication including aspirin, Plavix, warfarin, or other oral anticoagulant Allergic to lidocaine, epinephrine, cephalosporins, penicillins or chlorhexidine gluconate Individuals with a propensity for keloid scar formation Individuals with diminished decision-making capacity Current Smoking and use of other tobacco use.Pregnancy or current breast feeding for femalesTreatment Groups:Bioelectric Stimulation aloneBioelectric Stimulation Plus Amniotic Fluid injectionsBioelectric Stimulation Plus Amniotic Fluid Plus the Tesla BrushCross Over Option:All patients will have the option at the end of the initial 6 week treatment period to elect to cross over to the Group 3 treatment group for another 6 week period of treatment. They will have photos taken of the treatment area before beginning a second treatment period.Screening:Any subject with any of the three forms of hair loss described in the Inclusion Criteria who meet all Inclusion and none of the Exclusion criteria, will be eligible for participation. Each potential subject will have a brief history and examination performed by the Investigator, and if acceptable, will be provided with an overview of the study and offered an opportunity to review the Consent Form. If they choose to participate, and sign the Consent form, they will be enrolled in the study, and randomized one of the treatment groups described above.Screening Evaluation:All patients interested in enrolling in the study will have a screening evaluation to assure the safety and tolerability of the treatment regimen on a peripheral site such as arm or leg, before use on the scalp, by placement of two patch electrodes for transmitting the specific bioelectric signals. A bioelectric stimulation signal generator that has been previously tested and proven to be capable of delivering the required current, will be attached to the electrodes placed on the calf of the subject. Then the stimulator will be turned on and run through up to a 20 minute cycle of escalating micro-currents to a peak of 1.0 volts to test tolerability in each patient. If there is no significant skin irritation or pain or adverse effect at the end of the bioelectric stimulation, the patient will be eligible for participation in the study. Photo:All eligible subjects will then have a baseline photo taken with a Smart Phone camera of the requested treatment area prior to beginning treatment, to be compared to a photo of the same area at the end of the treatment period, and then at 1 & 3 months post treatment. This photo and all follow up photos will be forwarded to the data center.Treatment Regimen:Each patient will agree pre-treatment to be randomized to one of the treatment arms and have signed a consent form before any therapy can be given. The three treatment options are listed above.All treatment components will be provided to the clinic, including the bioelectric stimulators and amniotic fluid and DermaPen, which will be delivered in the office, as well as a Tesla Brush to those randomized to the treatment group, for daily use at home.Treatment Schedule:Bioelectric StimulatorAll participants will receive treatment with Bioelectric Stimulation. This will be delivered by placement of either two standard gel patch electrodes for those with male pattern baldness, or a head set this will be worn only for the 20 minute duration of the treatment for those with hair thinning or alopecia, for transmission of the specific bioelectric signals to the predetermined area of the scalp selected by the subject and investigator for treatment.All subjects will then have the level of micro-current of 0.1 volts delivered to either an arm of leg to prove tolerability and freedom from any adverse effects that would limit the 12 weeks of therapy.If the test stimulation is well tolerated, the patient will receive the bioelectric stimulation for a period of 20 minutes/treatment 2-3 times/week via the electrodes or headgear. Amniotic Fluid:(Group 2)Following delivery of the bioelectric stimulation, each subject randomized to Group 2 will then have a series of injections of the Amniotic Fluid via the DermaPen delivered by the Investigator. Treatments will be given once/week on the same day of the week for the entire 12 week treatment period, with at least five days between each treatment, ideally delivered on the same day each week.Amniotic Fluid will be injected once/week at one of the clinic visits each week on the same day of the week, in a total amount of 1-2 mls in 5-10 sites in the area of desired hair growth. A total of 4 ml may be used in up to 10 sites for patients with baldness. The fluid will be delivered by the DermaPen microneedle device which will be provided to the clinic and has an ability to be used for all patients with new cartridges.TeslaBrush: (Group 3)The subjects assigned to Group 3 will also receive a Tesla Brush for use at home for maximum periods of 15 minutes/day throughout the 12 week period of treatment.The medical professional will be fully instructed on the use of the Teslabrush according to the user guide provided with each device, and record the type brush assigned to each patient, HW or HB. The medical professional will adjust the output of the device in the clinic to identify the comfortable setting for each patient, and instruct the patient that this is the setting to be used for all home treatment, and will be reaffirmed at each clinic visit. Stopping Rules:Treatment will be stopped for any complaint by the patient of significant pain or discomfort, or local adverse effect. The patient will be allowed to return to treatment after a minimum of two days.Follow Up Evaluations:6, 12 weeks: Each patient will have a photo taken with the camera provided or available at the end of 6 weeks of treatment, and then again at the completion of the 12 week Treatment Period, of the same area identified pre-treatment.Each subject will also have a brief interview inquiring about any adverse effects noted by the subject since enrolling in the study, and an examination by the Principal Investigator for any scalp damage or injury. Grading Hair Growth:Both the subject and the investigator will independently grade the level of response and hair growth as Mild, Good, or Very Good.The patient will also be asked to return to the clinic for follow up at1 month post treatment: Repeat Photo, History, and Examination3 months post treatment: Repeat Photo, History, and ExaminationEnd Points:Primary Outcome Measure: All changes will be a comparison from baseline to after 6 and 12 weeks of treatment. End Points include Amount of Hair Growth Change in Hair Density(measured as number of hairs/cm2)Change in Hair Thickness Each of these 3 end points will be assessed independently by both the treating clinician and the patient.Secondary Outcome Measures: Incidence of treatment-related adverse events by the end of the treatment period to include but not limited to: local itching, bleeding, bruising, pain, or swelling of the scalp, headache, nausea visual changes, or palpitations. Data Analysis:Data will be collected for each patient at the specified times post treatment when the last enrolled subject has reached the 3 month post treatment time point. All data will compared between the subjects assigned to the Tesla Brush or primary treatment alone. There will be a separate analysis of patients who elect to cross over to a second course of treatment using the Group 3 combination therapy. All photos for each subject will be analyzed by an independent observer, who will be blinded to the treatment arm received by each patient. This assessment will be compared to the grade of improvement judged by the Investigator and the subject. Additional subjects may be enrolled into the study if approved by the IRB and Sponsor. ................
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