andrei_eremenko
Experienced Member
- Reaction score
- 2
some good news from TrichoScience:
"We received written approval to conduct the study on November 11, 2010 from the Georgian National Bioethics Committee. Biopsies from the 20 patients participating in the TS001-2009 study will be collected during the month of December 2010 and sent to Innovacell Biotechnologie AG in Innsbruck, Austria for processing. The study product will be ready for injection into study participants about mid-February 2011. At this time, participants will not only receive an injection of their replicated cells on one part of the scalp, but will also receive an injection of placebo (cellular transport medium without replicated cells) on the other side of the scalp. This will allow for better assessment of the safety and efficacy of our technology.
"We anticipate collecting data from the 6 month time point in early September 2011. This data will allow for analysis of our primary endpoint of the study in the form of an interim analysis. Patients will continue participating in the study through early 2013 when the 24-month visits will be conducted.
The first patient was enrolled into the trial on December 7, 2010. The remaining patients will be enrolled at the end of January 2011, following the Georgian orthodox holiday season.
Regulatory approval for our technology is subject to different regulations for different jurisdictions. Initiating human trials requires different depths and volume of pre-clinical research prior to approval for first-in-man trials. However, common to virtually all jurisdictions, is to demonstrate in humans the safety of the technology. Our first trial has been developed to prove safety first and efficacy second.
Commercial approval will require that safety has been demonstrated. However, commercial sales will only require that we demonstrate efficacy to the public. We will not be required to get approval from private or government insurance plans with respect to pharmacoeconomics, as the product purchase decision is not medical, but rather personal."
"We received written approval to conduct the study on November 11, 2010 from the Georgian National Bioethics Committee. Biopsies from the 20 patients participating in the TS001-2009 study will be collected during the month of December 2010 and sent to Innovacell Biotechnologie AG in Innsbruck, Austria for processing. The study product will be ready for injection into study participants about mid-February 2011. At this time, participants will not only receive an injection of their replicated cells on one part of the scalp, but will also receive an injection of placebo (cellular transport medium without replicated cells) on the other side of the scalp. This will allow for better assessment of the safety and efficacy of our technology.
"We anticipate collecting data from the 6 month time point in early September 2011. This data will allow for analysis of our primary endpoint of the study in the form of an interim analysis. Patients will continue participating in the study through early 2013 when the 24-month visits will be conducted.
The first patient was enrolled into the trial on December 7, 2010. The remaining patients will be enrolled at the end of January 2011, following the Georgian orthodox holiday season.
Regulatory approval for our technology is subject to different regulations for different jurisdictions. Initiating human trials requires different depths and volume of pre-clinical research prior to approval for first-in-man trials. However, common to virtually all jurisdictions, is to demonstrate in humans the safety of the technology. Our first trial has been developed to prove safety first and efficacy second.
Commercial approval will require that safety has been demonstrated. However, commercial sales will only require that we demonstrate efficacy to the public. We will not be required to get approval from private or government insurance plans with respect to pharmacoeconomics, as the product purchase decision is not medical, but rather personal."
