Note: Erica Jonlin, the author of the report and the regulatory manager at the University of Washington Institute for Stem Cell and Regenerative Medicine.
He states that “Differing standards for the NIH Stem Cell Registry and FDA approval render most federally funded hESC lines unsuitable for clinical use,” Cell Stem Cell, 14:139-40, 2014
:-) So, as a result, I would interpret this to mean, that ACTC stem cell qualified under the FDA guidelines. AND, ACTC is way ahead of the other stem cell biotech companies because '''''That’s because the FDA’s guidelines for using human-derived products require that donors be screened for a number of diseases.''''' “
Jonlin told the Scientiest, ""I can say most assuredly that most of the originating donors did not undergo the screening because it was never required,” My conclusion is that ACT's stem cell on NIH registry is one of the only hESC lines SUITABLE for clinical use SINCE FDA approved their trials. ACT is the hidden gem in the Stem Cell arena. Thank goodness that Dr. Lanza has taken so long (i.e. over 10 years) to get to this point. Good luck longs.
Again, when this news get out, ACT will be over the hump finally.
Sentiment: Strong Buy
Your going to have the bashers working overtime with that post....
i wonder if their daddy jim cramer will pay for all their meta carple tunnel syndrome they will be experiencing over the next few weeks.......
while i lmwao at the coallittlepecker clan and his cramer minions....
Sentiment: Strong Buy
Well, the author of the last SA article yesterday SAID, ""In fact, I did a simple search using the terms "iSPC induced pluripotent stem cells" and guess who was the first company name to populate the search results. Drum roll, please...yes, ACTC."" AND, ""
Advanced Cell is still the only company that I have found, with statistical relevance, that procures cells without destruction to the human embryo. Until that method is duplicated, Advanced Cell is sitting in a very strong position.""
Well, I agree. that, ACTC is the only player in the stem cell arena and is in a VERY strong position. Good luck longs. :-)
Sentiment: Strong Buy
Re: :-) So, as a result, I would interpret this to mean, ........
The Scientist Magazine
Stem Cell Lines Not Fit for Clinic
Most stem cell lines registered with the NIH don’t comply with the FDA’s guidelines for human use, according to a new report.
By Kerry Grens | February 6, 2014
Re: He states that “Differing standards for the NIH Stem Cell Registry and FDA approval render most federally funded hESC lines unsuitable for clinical use,” Cell Stem Cell, 14:139-40, 2014
Re: I don't think ACT has ever been eligible for federal funding.
NIH Approves Advanced Cell Technology's Stem Cell Line for Federal Funding
Access to Federal Funding Could Accelerate Clinical Development
June 11, 2010, WORCESTER, MA - Advanced Cell Technology, Inc. ("ACT”; OTCBB: ACTC) announced today that human embryonic stem cell (hESC) line MA135 was unanimously approved for federal funding at the 100th Meeting of the Advisory Committee to the Director (ACD) National Institutes of Health (NIH). In addition to MA135, seven additional stem cell lines derived at ACT are currently under review by the NIH. Five of these lines were produced without embryo destruction using ACT's proprietary single-blastomere "embryo-safe” technology. The federal funding could accelerate the company's clinical activities.
There were previously only 67 hESC lines eligible for use in NIH-funded research. "We are extremely pleased with the NIH's decision to add this line to their registry,” said Robert Lanza, M.D., Chief Scientific Officer of ACT. "This decision facilitates the use of embryonic stem cells as a potential source of replacement cells to treat a wide range of human diseases.”
"This approval is a watershed moment for the company, because it provides the company with the opportunity to pursue non-dilutive federally funded research programs utilizing a stem cell line derived solely by technology that we deployed,” said William M. Caldwell IV, Chairman and Chief Executive Officer of ACT. "We are optimistic that we will secure approval for additional lines using our single-cell blastomere technology in the coming months as the NIH finalizes their Proposed Rule Making expanding the definition of what will constitute a stem cell line that is eligible for federal funding. We applaud the NIH for its ongoing efforts to make more stem cell lines available to the scientific community.”