In December 2008 Cytori announced the following (excerpts):
Cytori (NASDAQ: CYTX) announced that the first patient was enrolled in an investigator-initiated study using adipose-derived stem and regenerative cells to treat the chronic effects of radiation-induced local tissue injury. The 30-patient study is being conducted independently by Nagasaki University Hospital in Japan.
Radiation-related tissue injury, poor wound healing, and deep skin ulcers are among the serious effects of cancer therapy and may also occur from exposure to nuclear materials. "Currently, few treatment options exist for these patients," said Dr. Sadinori Akita, assistant professor of surgery at Nagasaki University and principal investigator of the study. "Based on the early result of the first case and the more than 300 various clinical cases performed to date using the Celution 800 System output, we believe Cytori's regenerative medicine technology has the potential to become a standard of care for a very large group of patients with injuries resulting from radiation exposure."
Nagasaki University is sponsoring one of several independent, investigator-initiated clinical studies, which are expected to begin around the world in 2008 and 2009 using Cytori's Celution(R) 800 System. "This study is important to Cytori," said Marc H. Hedrick, M.D., president of Cytori. "Our Celution(R) System will be used by a worldwide leader in radiation damage research and creating potential opportunities for Cytori to work more closely with the WHO and IARC. Ultimately these relationships in combination with a successful study could result in the Celution(R) System becoming a standard therapy for radiation-related disease."
You can download the full announcement radiation-dec 08.pdf10.35 KB15/06/2012, 14:02:
What this concept of several independant studies around the world would entail, became clear when Sadorori Akita et al published a paper on their studies sometime in 2009-
As you can read in the last line- the goal of the study was a bit more than just radiation wound healing- its aim was to establish a global strategy for natural- and man-made disasters i.e. one can assume that Fukushima has been a practical test for the scientists at Nagasaki- the city where the second A-bomb exploded ending WW II. As you read in this paper from Akita- download akita-2010-radiation.pdf5.01 MB15/06/2012, 14:02-, he started off with BM cells, but switched to ADRCs with amazing succes late in 2008, but more about that later- first the "materials" used in this clinic-basically there are three components-
1. ADRCs from Celution (well known I guess) 2. Terudermis scaffold ( see picture below) 3. fibroblast growthfactor(also picture below)-
Regular readers of this site will remember those ingredients- they are also described in my Editor´s notes article- "Are the Olympus folks visionary?"
Terudermis is the silicon/collagen scaffold sold by Olympus-Terumo Biomaterials and the bFGF growth factor is for the Japanese trials delivered by Kaken, but the Olympus-Terumo JV licenced all RIGHTS TO THE PRODUCT FOR THE US AND EUROPE in 2009 shortly after commencement of the clinic.
Any doubts by anybody who are "behind the scenes" of this trial and promoted its start ?????????????
Early in 2010 Akita presented the results of the first three patients treated at the annual congress of the Academy of Wound Healing in Paris-download paper-akita-france.pdf1.9 MB15/06/2012, 13:59 before showing the same here, I suggest you view this video of the very first patient with Akita
explaining the procedure. The patient was a beautiful 89 year old lady- at the same time proving that fat cells are still very viable at an old age. Additionally you will hear Aki
ta speak for a few minutes on treating a male patient with HIV induced lipodystrophy of his face. This was an additional small trial conducted at Nagasaki and should be completed by now.
The same can be said of the 30 patient radiation wound trial- this probably moved also to Europe where the main competence centre for wound healing is in Montpellier, France (Luc Teot). The waiting really is for the initiators of the trial to come to terms and start marketing the procedure after EMA approval is received. The results for this unmet need are so convincing that hardly any doubt exists about its efficacy and safety.
The pictures are really impressive (case one is the old lady from the video):
In June 2012, we are roughly three years after the above video was produced in Nagasaki, which proved that the most dreadful chronic radiation wounds could be healed in about three months.
The controlling partner (67%) in the JV, Olympus has been rattled by its big accounting scandal, so probably has to decide whether to continue the path they clearly have been taking from 2004 to 2010 or dispose of their stake in the JV, which in my mind is worth north of 1 Bio$, looking at the assets of the JV.
Very difficult decision surely and most likely the main reason why Cytori hasnt been able "to wrestle down" a partner deal with the organization that has been instrumental in bringing the technology to the point where it is today. Coming back to the original goal of the Nagasaki group, which entails not only localized treatment of acute-or chronic radiation wounds, there could very well be a role for ADRCs in the systemic treatment of radiation injury-
Therapeutic management of radiation injury
For treatment of systemic radiation injuries, stockpiled stem cells should be globally available through medical assistance network system under WHO-REMPAN, in which Nagasaki University is highly involved in its activity, or other international frameworks. Early resurfacing of the damaged skin and subcutaneous tissues is as important as hematological and intestinal system resuscitation Also, therapeutic guidelines for systemic radiation injuries are anticipated from practical and regulatory view points. Highlighting innovative technology and devices as well as currently existing medicines and devices is expected for the sake of preparing to treat “systemic” radiation injuries most effectively.
Therapeutic regimens of radiation injuries used to be dependent on each subspecialty in the medical filed such as internal medicine, radiology, and surgery. Recent establishment of wound care specialty was mostly led by plastic surgeons, but other supporting specialists such as nurses, dermatologists, and gastrointestinal physicians and surgeons may be practically handling these rare but of significant impact “radiation injuries” as a interdisciplinary
approaches. Therefore, more specialization for “radiation injuries” may be required.