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Oud 14 maart 2017, 15:44   #1
inham123
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Replicel 24 maanden efficacy and 5 jaar safety data release

http://replicel.com/20170314-2/

Citaat:
RepliCel’s Phase 1 Clinical Trial For Hair Loss Succeeds In Meeting Primary Endpoints
Five-year safety data firmly establishes product safety and confirms ongoing clinical and product development strategy

VANCOUVER, BC – March 14, 2017 – RepliCel Life Sciences Inc. (OTCQB:REPCF) (TSXV:RP) (FRA6P2) (“RepliCel” or the “Company”), a clinical stage regenerative medicine company developing unique biologic products for pattern baldness and thinning hair, aging and sun-damaged skin, and chronic tendon degeneration, today announced the successful completion of its first-in-human clinical study of the Company’s autologous cell therapy for the treatment of androgenetic alopecia (pattern baldness).

The Company reports the trial succesfully met its endpoints and sets the stage for next steps in the ongoing research and development of its product, RCH-01, for the treatment of male and female androgenetic alopecia. “As we march toward commercialization of this product based on this first-in-human data, our aim is to revolutionize the way we prevent, treat, and even reverse hair loss,” stated RepliCel President and CEO, R. Lee Buckler.

Safety
The five-year trial data set has confirmed the complete safety profile of a high-dose of dermal sheath cup cells (DSCC) for patients with pattern baldness due to androgenetic alopecia.

These DSCC form the basis for the Company’s RCH-01 product. The long-term safety of DSCC injections was demonstrated through multiple physician, patient and independent measures of local and systemic tolerance including evaluation of adverse events with respect to causality, incidence, severity and seriousness. No serious adverse events were reported over the entire 60.5-month follow-up period of the trial. Local injection tolerance was confirmed with only a few minor scalp irritations reported around injection sites that resolved quickly soon after injection. Furthermore, histopathological evaluation of injection site biopsies taken six, 12, and 24 months after injection did not reveal any pathology that was suggestive of tumour, granuloma or foreign body formation. An analysis of injection site biopsies taken 60.5 months after injection is currently ongoing with results expected in the next few weeks. Long-term systemic safety of RCH-01 was also confirmed as none of the systemic adverse events reported during the extended safety evaluation were related to treatment.

Indications of Potential Efficacy
The trial was designed to gather data related to the product’s potential efficacy through 24 months post-injection, but was not designed for statistical significance related to any efficacy endpoints. The efficacy data collected from all 19 patients, while not statistically significant, provides useful and potentially exciting insights into the product’s potential for the treatment of those with androgenetic alopecia.

“We have a much greater understanding and opportunity for further insights from the hair density responses recorded in this first-in-human trial,” stated RepliCel President and CEO, R. Lee Buckler. “This data will feedback into our R&D programs and help us develop the best possible product and treatment protocol for men and women suffering from androgenetic alopecia.”

The seven top-tier responders in the trial saw >10% increase in hair density at six months post-injection (see May 17, 2012 announcement). At 24 months, the average hair density increase for these same seven participants was 8.3% over baseline, and three of these seven trial participants maintained a >10% increase in density over baseline. The largest increase in hair density over baseline observed in this group was a 21% increase at 24 months.

The top 10 participants reported at least a 5% or greater increase in hair density at six months post-injection with an average increase of 11.8% (as reported in the May 17, 2012 announcement). This group demonstrated a sustained response at 24 months which averaged a 4.2% increase over baseline hair density. While there was a high degree of variability in hair density between individual participants at 24 months post-injection compared to baseline, an overall stabilization of hair loss was observed among all the patients treated per protocol.

Management Commentary
“The purpose of collecting efficacy data in these early-stage trials,” stated RepliCel’s Clinical Consultant, Darrell Panich, “is for our clinical team and management to obtain data that can be used to inform basic decisions about further development, provide provocative insights into the product’s potential, and – perhaps most importantly – provide useful feedback which we can use to drive decisions about process and product development, ongoing research, and future clinical trial parameters.”

“We are very pleased with the unquestionable safety profile of RCH-01,” stated RepliCel’s co-founder and Chief Medical Officer, Dr. Rolf Hoffmann. “Five-year safety follow-up is rare for cell therapy products and demonstrates our commitment to the highest quality of clinical research. Furthermore, the efficacy signals we see validate the research and development strategy we have had in place since we saw the six-month post-injection data in 2012.”

Hoffmann continued: “Over the past 36 months, we have invested a great deal in both basic research and manufacturing optimization which we believe will be critical to minimizing batch-to-batch variability and further improving efficacy. We have invested in process and product development initiatives including a modified tissue culture technique, improved culture media with addition of 12 new ingredients, introduction of a cell activity promoting step, and cryopreservation storage to improve cell stability and viability. We believe these programs have already resulted in a significantly more robust and better-defined product than the one used in this trial by many measures and look forward to translating our continued R&D into next-phase clinical trials in due course.”

“This trial involved the injection of a very high dose of DSCC in order to identify any potential toxicity ceiling in accordance with the primary safety objectives of the trial. The efficacy data we saw in this trial, together with recent animal research data, suggests that long-term survival of injected cells improves both with smaller dose size and with several sessions of injections spaced-out over a set time course to cumulatively increase injected cell numbers,” stated RepliCel’s co-founder and Chief Scientific Officer, Dr. Kevin McElwee. “We expect cell number and long-term cell survival to be correlative with hair density efficacy. Next-phase trials will be designed to test repeated injection sessions with smaller cell doses than were used in this study.”

“Furthermore,” continued McElwee, “with this 24-month post-injection data, and the availability of patient biopsy material and DSCC, we are now able to commence gene expression analysis with a goal of identifying the differences between products which result in superior responses and those that produce less-than-optimal responses. Ultimately, the goal here is to correlate and optimize cell dose and use repeat treatment sessions to achieve peak efficacy in terms of increased hair density.”

“In summary,” stated RepliCel’s President and CEO, R. Lee Buckler, “we are very pleased with the results of this first-in-human study and are excited to move this product forward into the next phases of development.”

Buckler concluded: “The analysis of data collected from this study, and the direction it gives our research and development programs, will support further optimization of the RCH-01 treatment to be evaluated in future phase II clinical trials. This data, combined with results expected next year from the Shiseido-funded study ongoing in Japan, will support future negotiations with regulators and licensees as we march toward RCH-01 commercialization. Additionally, we are confident that using RepliCel’s RCI-02 injection device (currently under development) in future trials will better control the dose, distribution, and depth of injections to the scalp of study participants. We expect this to further positively impact the product’s efficacy and the uniformity of response.”

About the RCH-01 Clinical Trial (2011 – 2017)
The TS001-2009 first-in-human clinical trial was designed to test the safety and efficacy of dermal sheath cup cells (DSCC are the basis for the Company’s current RCH-01 product) in men and women with androgenetic alopecia. The primary protocol objective of the study was to assess the local (at treatment sites) safety profile of injections. Secondary protocol objectives were to assess systemic (whole-body) safety and local efficacy (hair growth at treatment sites). A total of 19 subjects (10 male and nine female) were recruited for the trial and all of them completed 24-month post injection follow-up visits. Seventeen of those patients went on to complete a full five years of extended safety evaluations to provide information on the long-term safety of DSCC injections. For further details about the trial design, endpoints, etc see https://www.clinicaltrials.gov/ct2/show/NCT01286649.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company’s product pipeline is comprised of two recently completed clinical trials (RCT-01 for tendon repair and RCS-01 for skin rejuvenation), as well as, its RCH-01 hair restoration product under exclusive license by Shiseido Company for certain Asian countries. All product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles. RepliCel has also developed a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Please visit http://replicel.com/ for additional information.

For more information, please contact:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com
Ik ga ervan uit dat de citaat uit de eerste dikgedrukte tekst betekent dat ze over een paar weken de efficacy data voor 5 jaar bekend maken. Zal erg spannend worden. Volgend jaar in de tweede helft van 2018 komt de data van Shisedo's eigen studie naar de Replicel technologie uit. Na het publiceren van deze studie mag Shisedo in rap tempo de technologie op de markt brengen in Azie, en Replicel verwacht dat ze dit eind 2018 of begin 2019 doen.

Twee grote vraagtekens:
1. De studie is op vrouwen en mannen gedaan, maar ik kan niets vinden over hoe goed het per geslacht werkt? Weet iemand dit?
2. Ik kan ook niet vinden op welk deel van het hoofd dit getest wordt, het werd op vrouwen met Ludwig-schaal haarverlies getest dus ik ga ervan uit niet alleen op de kruin? Weet iemand dit?

Hier is de thread erover op hairlosstalk forums: https://www.hairlosstalk.com/interac...103266/page-36

Hun originele 6 maanden efficacy data is hier te vinden: http://replicel.com/wp-content/uploa...s-Nov-2012.pdf

Als je dat PDF-bestand er bij pakt terwijl je de geciteerde tekst leest dan is het duidelijker wat voor resultaten ze hebben, want ze verwijzen steeds naar hun 6 maanden efficacy data.

Laatst gewijzigd door inham123; 14 maart 2017 om 16:08
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Oud 14 maart 2017, 19:05   #2
Pionier
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"an overall stabilization of hair loss was observed among all the patients treated per protocol."

Dit hier is het belangrijkste, we mogen minstens stabilisatie verwachten en dit zonder bijwerkingen.

Een echte doorbraak imo.

Dit in combinatie met een ht, is een oplossing.

Maar ben wel benieuwd of men 1 injectie/jaar of om de 5 jaar ofzo moet zetten...
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Oud 14 maart 2017, 20:34   #3
Hater
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Dit is de goeie shit, ik zat ook al een beetje te volgen op hairlosstalk.

Dit is het enige waar wij op kunnen hopen
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Oud 14 maart 2017, 21:24   #4
inham123
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Oorspronkelijk geplaatst door Pionier Bekijk bericht

Maar ben wel benieuwd of men 1 injectie/jaar of om de 5 jaar ofzo moet zetten...
5 jaar efficacy data komt waarschijnlijk in een paar weken.

Ik zat net te denken en zelfs de personen die minder haar dan baseline hebben hadden stablisatie. Het kan zo zijn dat de mensen die onder baseline zitten wel haarhegroei hebben gehad, maar dat die hergroei lichter was dan het verlies van bestaande haren voordat de stabilisatie van het haarverlies door de behandeling in werking trad. Dat is wel een grote aannamen uiteraard.

Blijkbaar heeft de haarwetenschapper(?) Jahoda eind jaren 90 DSC-cellen van zijn haar in de arm van zijn vrouw geinjecteerd, waarna er haargroei plaatsvond.

Als ze die haargroei kunnen perfectioneren dan zou mogelijk HTs niet meer nodig zijn in de toekomst.

Een ander voordeel is dat deze behandeling (als het uiteraard ook echt werkt en Replicel belazerd de boel niet) het mogelijk maakt om niet-permanent haar permanent te maken, dus mogelijk maakt het het aantal grafts van de donorregio bij een haar transplantatie groter.
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Oud 19 maart 2017, 12:04   #5
zyzzalive
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Snel op de markt brengen dit. Replicel behandeling met HT en je hoeft niet misschien niet meer aan het gif wat finasteride heet.
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Oud 29 maart 2017, 09:03   #6
nicolaasdk
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Vergif? Als je 5 liter water achter elkaar opdrinkt is water ook vergif. Gevoeligheid verschilt per persoon en is dosis afhankelijk.
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Oud 1 april 2017, 22:48   #7
zyzzalive
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Oorspronkelijk geplaatst door nicolaasdk Bekijk bericht
Vergif? Als je 5 liter water achter elkaar opdrinkt is water ook vergif. Gevoeligheid verschilt per persoon en is dosis afhankelijk.
Jij vergelijkt finasteride met water? Nou succes ermee dan
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Oud 2 april 2017, 17:50   #8
HairCoach
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Je hebt de keuze om finasteride te gebruiken en je huidige haardos nog enkele jaren te behouden OF om niks te gebruiken en het verder zien afnemen.

Niks moet....Als je het vergif vindt, vooral links laten liggen.

En nee, daarmee zeg ik niet dat het een snoepje zonder risico is.
__________________
Regime:
Finasteride(2001 tot 2003, herstart 02-2008 -> ) op di, do, za en zo,
Dutasteride 0,5mg op ma, wo en vr
Tuinen Super Haar Formule
Omega 3
Biotine (3000mcg per dag)
Vitamine D3 (2000mcg)
Toco-Sorb (1x/dag)
Spiruella MSM (6000mg per dag)
Revita & Alpecin Shampoo

Behandelingen:
1e HT: 2000; 650 grafts FUT dr. Feriduni inhammen.
2e HT: 2001; 700 grafts FUT dr. Villnow verdichting/herstel 1e behandeling.
3e HT: 07-2014; 2240 grafts FUE herstel eerdere behandelingen - Prohair
4e HT: 09-2016; 800 grafts Verdichting / Herstel haarlijn FUE - Kliniek Veldhoven.
5e HT: 12-2017; 600 grafts temples FUE - Kliniek Veldhoven


Status:
NW1
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