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Ale_86
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www.youtube.com/watch?v=gnrb3LBMV64
Intervista di un membro di un forum americano con quelli di Replicel.
Qui sotto un altro utente del forum riassume i punti salienti:
The Japanese trial phase was listed TBD in their presentations because of the nature of Japanese regulation differences (3:50).
They clarified that IPS cell usage was a misunderstanding (4:40, 32:25). Shiseido are going to use DSC cells; same as RepliCel.
Converted hair follicles with DSC cells will be potentially permanent, but not all follicles may be converted with one injection. This is still a hypothesis though (6:55).
Shiseido may only be trialing a single dosage (8:30).
Cannot store cells for follow-up and would require a new sample, but potentially can be done off-label (9:15).
Cells do not lose inductive properties over time. They have stored cells for a year and technically can last years (11:25).
Next Phase trials in Japan and should start within the next couple of months (12:20). RepliCel will be starting their trial in Germany in 2016 (13:00).
The Phase II delay was caused by GE (14:30). The issue was because of discontinuation of culture medium. It takes 12 weeks per experiment to culture/verify data (15:40), hence the long delays.
There is no ruling whether the German regulators will accept the new culturing method, therefore, there is risk that they will have to restart their trials (17:20).
There may be synergy effect using RepliCel with Histogen, but probably not necessary (21:30). Trialing them together would be difficult (23:00). This would be a Phase 4 trial (post market).
Shiseido will start trials first (24:25).
RepliCel will try to find minimum dosage used to regrow hair (25:40).
They will not try wounding, since act of injecting is effectively a wound itself (27:00). They are not believers in wounding it appears (27:20). Hellouser doesn't sound to be much of a fan either ( 29:30).
SwissTemples is an example that even with miniaturization there are still hair cells and thus should be responsive to treatment (31:50).
Shiseido is working with Harvard on other techniques, but for this product the development is collaborative between RepliCel and Shiseido (32:25).
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1384 replies since 5/5/2011, 10:40 99546 views
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