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TOPIC: Hamstring injury study to be initiated

Hamstring injury study to be initiated 13 Jan 2014 07:48 #1208

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Cytori has received Investigational Device Exemption (IDE) approval from the FDA to begin a prospective clinical trial to evaluate the safety and feasibility of Cytori Cell Therapy as a potential treatment for hamstring injuries. The trial, referred to as RECOVER, will begin as a ten-patient, open label study in 2014. Following a 90-day assessment of the first ten patients, Cytori is approved by the FDA to expand RECOVER to a multi-dose, multi-center, double-blind, placebo-controlled trial. Cytori Cell Therapy is derived from the Company’s Celution® System, which enables access to a patient’s own adipose-derived regenerative cells (ADRCs) at the point-of-care.

RECOVER will evaluate Cytori Cell Therapy in patients with Grade II tears of the hamstring muscle. RECOVER will initially enroll ten patients in the United States. The first ten patients will be given one of two doses of Cytori Cell Therapy in an open-label manner, with the first five patients receiving the lower dose and the second five patients receiving the higher dose. Once the safety and feasibility of administering Cytori Cell Therapy has been confirmed in the first ten patients (Part A), Cytori has the option to expand RECOVER to include an additional 60-patients in the multi-center, double-blind, placebo-controlled phase of the trial (Part B). The 60 patients would be divided into three groups of 20 patients. Patients in a given group will receive a lower dose, a higher dose or placebo. The study would assess safety and tolerability and evaluate the effect of the cells on how fast the muscle tear heals (ultrasound and MRI), muscle strength, muscle function and pain. The timeline to complete the first phase of the study will be provided once the trial is initiated and Cytori is able to forecast enrollment.

“We have been studying ADRCs in acute and chronic muscle injuries in the heart for more than a decade and Cytori Cell Therapy is thought to play a role in improving perfusion and reducing inflammation in damaged cardiac muscle,” said Christopher J. Calhoun, Chief Executive Officer of Cytori. “Similarly, we believe ADRCs could support healing in injured skeletal muscle such as that of a hamstring injury. Initially, RECOVER involves a minimal, incremental investment for the first ten patients. If successful, RECOVER may provide an accelerated path to market in the U.S. targeting the millions of recreational and professional sports injuries that occur each year.”

Cytori is building a cell therapy sports medicine business. In the U.S., the Company is pursuing a clinical development strategy initially with the RECOVER trial. Internationally, the Company is in the process of initiating two multi-center registries for related indications in countries where the Celution® System is available for commercial use. The ACHILLES Registry will collect data from patients with muscle and ligament injuries treated with Cytori Cell Therapy and the RELIEVE Registry will collect data from patients with osteoarthritis. Both registries will collect patient data and may support future regulatory and reimbursement efforts.

About Hamstring Injury

Hamstring injuries are a persistent problem among elite and amateur athletes given the high incidence and recurrence rates, as well as the lengthy recovery time. According to the Journal of Orthopaedic & Sports Physical Therapy, nearly one third of hamstring injuries recur within the first year following a return to sport, with subsequent injuries often being more severe than the original.

About Cytori Cell Therapy and ADRCs

Cytori Cell Therapy is a proprietary formulation of a patient’s own regenerative cells derived from their own adipose (fat) tissue that is delivered in the same surgical procedure using the Company’s Celution® System. Adipose tissue is the richest source of stem and regenerative cells in the body. This mixed population of cells, collectively referred to as ADRCs, is accessible at the point-of-care through the Celution® System for use in the same patient, creating new treatment opportunities for currently unmet medical needs. ADRCs collectively contribute to the healing process via cell-to-cell signaling, supporting improved blood flow and regulation of the inflammatory response.

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Hamstring injury study to be initiated 13 Jan 2014 07:57 #1209

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Cytori is building a cell therapy sports medicine business. In the U.S., the Company is pursuing a clinical development strategy initially with the RECOVER trial. Internationally, the Company is in the process of initiating two multi-center registries for related indications in countries where the Celution® System is available for commercial use. The ACHILLES Registry will collect data from patients with muscle and ligament injuries treated with Cytori Cell Therapy and the RELIEVE Registry will collect data from patients with osteoarthritis. Both registries will collect patient data and may support future regulatory and reimbursement efforts.


As we know- status August 2013- there were 10 Ortho/Sports Medicine studies underway outside the US



Some of them will end up in these mentioned registries I presume.

One of the known users of Cytori Cell Therapy is Ramon Cugat- medical doctor for the FC Barcelona- the second best soccer team on the world- it is believed he already treated some high profile soccer players-

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Hamstring injury study to be initiated 13 Jan 2014 08:07 #1210

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I think this should not be that much of a big surprise- the international work probably shows that it works well.

If this trial goes fast and is successful (as I expect)- this will get the Celution in orthopedic practices and "off-label" use will catapult this thing for all kind of ortho and other uses. :grin:

the start of :vegas:
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Hamstring injury study to be initiated 13 Jan 2014 08:09 #1211

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Maybe they can use the NEW generation Celution already- I hear it is ready and in testing.... :nice:

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Hamstring injury study to be initiated 13 Jan 2014 08:50 #1212

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If a player like Messi has a hamstring injury, the cost is huge. These players bring in millions, not only in merchandising but also with the goals they score. Messi has one of the highest hit ratio's ever.
If he can recover a couple of weeks earlier than with 'classic' treatment, it's worth a lot of $$$$$
As a matter of fact, he played this WE coming back from an injury.... (but he didn't score)

"He definitely needed to rest physically because he had already suffered this [injury] and there was no other option than to stop playing," Fábregas said to Marca. "He had four or five injuries in a row in a muscle that he uses a lot in accelerating from a standstill, which is what sets him apart. He had to stop no matter what and he'll be like a bull when he is back."

Fas, an injury in a muscle...that sounds treatable with Cytori technology... :-)

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Hamstring injury study to be initiated 13 Jan 2014 10:03 #1213

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Fas or others who wish to comment:

1. Given Cytori's experience with different EU regulations in each individual country hampering progress and one reason for holding off on ADVANCE trial....what are the chances these international trials will be limited to one or possibly two countries ?

2. What are the chances that these trial applications will also be sponsored by EU governments saving Cytori valuable cash ?

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Hamstring injury study to be initiated 13 Jan 2014 11:00 #1215

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On 1- Calhoun already has mentioned some of the countries that sponsor Celution trials- UK, Germany, France, Italy and Switzerland- thats already 5 known and there should be a dozen. Thats already quite a lot more than 2.

Hedge- I think Cytori wanted the focus off Europe, simply since japan is more promising- but than again- most studies- 34 are in Europe, which is simply self-driving. At one point in time that means specific claims i.e. approvals and 3-4 years later reimbursement.

As mentioned before- ADVANCE will likely be picked up by private investigators and the result recorded in registries already set up.

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Hamstring injury study to be initiated 13 Jan 2014 13:01 #1216

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Fas..I dont know why only the EU came to mind for these new international trials. Thanks for clarifying.

Hopefully they are sponsered...although the double edge sword is we rarely get the data in a timely fashion that way.

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Hamstring injury study to be initiated 14 Jan 2014 09:38 #1220

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Dr. Hammer posted the Cytori news at LinkedIn, so my priority was the comment on that-

Thanks for posting this Richard. Since I have a known positive "bias" towards the Cytori technology, I preferred to wait and see if somebody else had an interest and therefore did not post myself.
Maybe I can put a few footnotes. The most relevant events leading up to this planned trial in the US, was the broad therapeutic claim on the extraction device Celution, that Cytori received from the European Competent Authority in August 2012. The claim was for : "Deficiencies or injury to: skin, fat, muscle and fascia" and this allowed doctors in Europe to do similar treatments as Dr.Purita did on Bartolo Colons pitching arm with the blessing of regulatory authorities.
To my knowledge- several progressive doctors in the orthopedic space took advantage of this and several KOLs (Key Opinion Leaders) have worked on advancing the technology. One of those- as an example is Dr. Ramon Cugat, medical doctor of FC Barcelona-known Cytori Cell Therapy user- who was quoted recently as:
“Mesenchymal stem cells have had a big impact on orthopaedic surgery over a short period of time,” said Ramon Cugat, MD, PhD, who is president of the medical council for the Catalan Soccer Delegation’s Health Insurance Company under the Spanish Soccer Federation. “This impact continues to grow on a daily basis. “The big difference between treating with cells and traditional treatments is that cells focus on regeneration,” said Cugat, an Orthopaedics Today Europe Editorial Board member. “Until now, orthopaedic surgery has focused on restoring the anatomy and recovering function. Now it is time to work with biology.”
For Cytori investors, this US trial probably is the only thing they look at- for me- somebody who tends to be more interested in the progress of technological development, the registries which are being launched in Europe now will have a much more relevant and important impact in moving forward therewith.
And probably are also more relevant for third parties with deep pockets, who have similar attitudes


So- maybe I will listen to the Biotech presentation now.... :joy:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
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