Embryonic Stem Cell treatment for Stargardt 's starting soon

A company call Advanced Cell Technology based in Massachusetts has applied for an IND (investigational new drug) application with the FDA.  This application would allow them to start a phase 1 trial for using Embryonic Stem Cells to treat Stargardt 's disease in 12 people. 

This would be only the 2nd time the FDA approves the use of Embryotnic Stem Cells for treatment.  The 1st was for the treatment of paraplegics but that study has been on hold since January.

ACT has had promising results with curing macular problems in rats and in other animal trials.  This would be a milestone for medicine in general opening up a new field called Regenerative Medicine.

Here is ACT's press release in its entirety.

WORCESTER, Mass., Sept 22 (BUSINESS WIRE)—Advanced Cell Technology, Inc. (OTCBB:ACTC.PK–News) provided an update on pre-clinical activities in preparation of its first IND filing with the Food and Drug Administration for its retinal pigment epithelium (RPE) cell program for the treatment of various eye diseases. In the next few weeks, the Company will be completing the preclinical work necessary for filing the IND. To date, no adverse events have occurred in testing. The results will be part of the submission which Advanced Cell expects to submit to the FDA prior to the end of the year.

“We are very pleased with the long-term safety and efficacy data,” said Dr. Robert Lanza, ACT’s Chief Scientific Officer. “We have carried out pre-clinical studies using these cells in multiple animal models, and to-date have not seen any teratoma formation or untoward pathological reactions. We are optimistic that human embryonic stem cells (hESCs) will serve as a potentially safe and inexhaustible source of RPE for the treatment of a range of macular degenerative diseases.”

“We are pleased with the progress we have made in preparation for the FDA submission,” said William M. Caldwell IV, Advanced Cell’s Chairman and CEO. “In the retina, compromised RPE function can lead to deteriorated vision and photoreceptor loss in both age-related macular degeneration and other forms of degenerative eye disease. We look forward to further studying the role that our RPE cells can play in providing a potential solution to this problem.”

This is very exciting and we'll have to keep an eye on this company and this trail.

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Update: The application has been approved!