-
Just received this email update, it seems they have dropped a test participant to keep to their desired time frame:
VANCOUVER, BC – September 7, 2011 - RepliCel Life Sciences Inc. is pleased to report that the final study participant has received injections of hair follicle cells prepared using RepliCel™ technology. This milestone marks the end of the treatment phase of the TS001-2009 clinical trial in which a total of nineteen participants received injections. To date, no serious adverse events have been reported post-injection. Please note that recruitment of subjects was closed at nineteen (rather than the planned twenty) to allow for timely processing of interim analysis data from the six-month follow-up time point. This interim analysis is scheduled to take place in Q1, 2012.
-
Originally Posted by Zoidberg
Just received this email update, it seems they have dropped a test participant to keep to their desired time frame:
VANCOUVER, BC – September 7, 2011 - RepliCel Life Sciences Inc. is pleased to report that the final study participant has received injections of hair follicle cells prepared using RepliCel™ technology. This milestone marks the end of the treatment phase of the TS001-2009 clinical trial in which a total of nineteen participants received injections. To date, no serious adverse events have been reported post-injection. Please note that recruitment of subjects was closed at nineteen (rather than the planned twenty) to allow for timely processing of interim analysis data from the six-month follow-up time point. This interim analysis is scheduled to take place in Q1, 2012.
Wow I'm excited to see the results.
-
Originally Posted by Zoidberg
Just received this email update, it seems they have dropped a test participant to keep to their desired time frame:
VANCOUVER, BC – September 7, 2011 - RepliCel Life Sciences Inc. is pleased to report that the final study participant has received injections of hair follicle cells prepared using RepliCel™ technology. This milestone marks the end of the treatment phase of the TS001-2009 clinical trial in which a total of nineteen participants received injections. To date, no serious adverse events have been reported post-injection. Please note that recruitment of subjects was closed at nineteen (rather than the planned twenty) to allow for timely processing of interim analysis data from the six-month follow-up time point. This interim analysis is scheduled to take place in Q1, 2012.
god help them help me
-
Some news from Replicel i received today:
"RepliCel Injects Final Patient with Hair Follicle Cells in its First-In-Man Clinical Trial TS001-2009
VANCOUVER, BC – September 7, 2011 - RepliCel Life Sciences Inc. (the “Company” or “RepliCel”) (OTCBB: REPCF) is pleased to report that the final study participant has received injections of hair follicle cells prepared using RepliCel™ technology. This milestone marks the end of the treatment phase of the TS001-2009 clinical trial in which a total of nineteen participants received injections. To date, no serious adverse events have been reported post-injection. Please note that recruitment of subjects was closed at nineteen (rather than the planned twenty) to allow for timely processing of interim analysis data from the six-month follow-up time point. This interim analysis is scheduled to take place in Q1, 2012.
In the next stage of the TS001-2009 trial, the post-injection follow-up period, subjects return to the study centre to have their health closely monitored to ensure that there have been no adverse effects associated with receiving the injections and to determine the hair growth stimulating efficacy of the hair follicle cell injections.
Once the final patient has completed their six-month follow-up visit, an interim analysis of all collected data will be performed to assess the primary outcome measure of the TS001-2009 study. The analysis will involve assessment of the local (at treatment sites) safety profile of autologous hair follicle cells compared to placebo as defined by AEs with respect to their causality, incidence, severity and seriousness. Secondary outcome measures of systemic (overall) safety (through review of adverse events in a similar fashion as described above) and efficacy (hair growth at treatment sites) will also be performed at this time. Subjects will participate in the post-injection follow-up period of the study until August 2013 and final analysis of safety data should be available in late 2013. "
Six months later from the first patient injection, no side effects. Lets get this safety issue solved and move.
-
Administrator
RepliCel Interview - Spencer Kobren Speaks With David Hall
-
Ah thank you that was needed
-
****, 2015? Will it come out earlier in Europe or Asia`?
-
Originally Posted by krewel
****, 2015? Will it come out earlier in Europe or Asia`?
This is a good thing as far as safety is concerned. Remember, it helps everyone involved to get it right the first time. If they rushed it and some minor defects showed up later on, the FDA would squash the whole thing like they've done with cholesterol drugs, etc.
-
Originally Posted by Bronson
This is a good thing as far as safety is concerned. Remember, it helps everyone involved to get it right the first time. If they rushed it and some minor defects showed up later on, the FDA would squash the whole thing like they've done with cholesterol drugs, etc.
I thought FDA is something thats not needed in Europe and Asia? Shit, this is bad news. I'll be one of RichardDawkins gang now, hahaha.
-
Hi, has anyone in the UK signed up for the clinical trials of RepliCel? And if so, have you received any confirmation, notification or communication? Thanks.
Tags for this Thread
Posting Permissions
- You may not post new threads
- You may not post replies
- You may not post attachments
- You may not edit your posts
Forum Rules
|
» IAHRS
» The Bald Truth
» americanhairloss.org
|
Bookmarks