Cytori has announced it has been informed that seven new investigator-initiated clinical studies in Japan using adipose-derived regenerative cells have been approved by local ethical committees.
The approvals are at leading academic university hospitals and include a diverse group of therapeutic applications.
All seven studies are investigator-initiated and to be performed under local and country guidelines. Cytori, who will not sponsor these studies, will continue work with country authorities, such as the Ministry of Health and Labor in Japan, to obtain specific regulatory approvals for its products. Data from these investigator-initiated studies may benefit Cytori in the future by establishing and broadening the utility for Cytori's Celution System platform currently sold in more than 30 countries around the world.
"There is a real groundswell of interest within the medical community to explore the full potential of adipose-derived regenerative cells," said Marc H. Hedrick, M.D., President of Cytori Therapeutics. "In countries where we have regulatory approval today, there may be an emerging market for the sale of Celution Systems for cell processing and for translational research similar to the work being performed in Japan."
Investigator-initiated studies are sponsored entirely by each hospital, which independently oversees data monitoring and reporting. The breadth of applications being investigated reflects the broad potential for adipose-derived regenerative cells. The indications being investigated in the seven new studies are as follows:
- Restoration and reconstruction of facial wasting induced by HIV therapy
- Restoration of speech from vocal cord paralysis
- Breast reconstruction after cancer treatment without radiation therapy
- Healing of chronic wounds
- Chronic liver insufficiency and cirrhosis
- Urinary incontinence in female patients
- Peripheral vascular disease