Tissue Therapies Limited has announced that it has overcome a major hurdle in the race to use human embryonic stem cells for medical treatment with the discovery that its VitroGro® technology can be used to replace animal or human serum in the culture of human embryonic stem cells.
Research conducted at Queensland University of Technology's Institute of Health and Biomedical Innovations showed that human embryonic stem cells can be grown using Tissue Therapies' VitroGro®, eliminating the need to use human or animal serum to culture cells.
Tissue Therapies CEO Dr Steven Mercer said the breakthrough finding potentially removed one of the most significant obstacles to approved use of stem cell therapies.
Dr Mercer said the American Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA) had been extremely concerned that the use of animal- or human-derived serum to grow human embryonic stem cells could result in the transmission of infections to humans treated with these cells.
"Until now, there have been no alternatives to serum for the growth of human embryonic stem cells, and this has been a major impediment to the ultimate approval of stem cell therapies for human treatment," Dr Mercer said.
"The QUT research proves that the presence of Tissue Therapies' VitroGro® allows human embryonic stem cells to be grown through more than 20 generations without serum, with no impact on the integrity of the cells," he said.
"This is a unique and exciting scientific discovery with huge implications for the scientific, medical research, and therapeutic uses of human embryonic stem cells," Professor Upton said.
Dr Mercer said the discovery had significant potential to accelerate the practical application of human stem cell therapies to develop cures for a wide range of devastating diseases.
"The eradication of animal or human serum from the stem cell culture process removes one of the most serious and difficult heath regulatory objections to the use of stem cell therapies in humans," he said.
"Tissue Therapies is currently in negotiations with a number of large international companies who supply cell culture products or use various types of human stem cells."
"We will be working with them to translate this into practical clinical outcomes for patients, as well as commercial returns for Tissue Therapies shareholders."
"This research validates and demonstrates the versatility and power of the VitroGro® technology," Dr Mercer said.
"We expect to confirm additional clinical applications of the VitroGro® technology over the next 12 months."