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TOPIC: Cugat starts another meniscus study in Europe

Cugat starts another meniscus study in Europe 10 Feb 2015 08:03 #3371

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02/10/2015
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that the first patient was enrolled and treated this week in a single arm, open label investigator initiated trial of Cytori Cell Therapy in patients undergoing surgery for traumatic meniscal injuries in the knee.

The principal investigator and treating surgeon was Dr. Ramon Cugat, Co-Director of the Orthopedic Institute, Hospital Quiron Barcelona. This is a parallel study to an ongoing evaluation of Cytori Cell Therapy for anterior cruciate ligament (ACL) repairs. Although follow up is ongoing in the ACL trial, preliminary results presented at the Barcelona Knee Symposium in November 2014, indicated no safety related concerns and possible efficacy.

“Dr. Cugat is a leading expert in treating traumatic knee injuries in elite athletes,” said Dr. Marc H. Hedrick, President and CEO of Cytori Therapeutics. “These trials are important to Cytori because, at minimal cost to us, they provide additional clinical evidence that our therapy can be safely used in treating a multitude of knee conditions.”

The meniscus investigator initiated trial is a two center phase I study of the safety and efficacy of Cytori’s ECCM-50 adipose derived regenerative cell therapy delivered by injection into the surgically repaired meniscus in up to 60 patients. A number of exploratory endpoints will be measured related to functional recovery of the patient after surgical repair. Similar to the ACL repair study, the goal of this trial is to assess whether Cytori Cell Therapy can be safely delivered to the meniscus and whether efficacy can be observed.

“Tears to the meniscus are problematic injuries for active individuals, particularly athletes. Based on the early results from a recent series of 20 patients treated for complete anterior cruciate ligament injuries, we are eager to evaluate whether augmentation surgery with Cytori Cell Therapy will lead to quicker and more complete healing,” said Dr. Ramon Cugat.

The endpoints for the trial include patient reported outcomes questionnaires of pain, function and activity, including the Knee Injury and Osteoarthritis Outcome Score (KOOS), knee pain assessed by visual analogue score, Lysholm Knee Scoring Scale, Tegner Activity Scale, and the Lower Extremity Functional Scale. In addition, the study will evaluate the structure of the meniscus through Magnetic Resonance Imaging (MRI). Patient reported outcome assessments will be performed before and 60, 90, 180 and 365 days after surgery and with MRI before and at 90, 180 and 365 days after surgery.

Preliminary ACL study results demonstrated the procedure was feasible and not associated with safety issues above that seen with a standard small volume liposuction. All patients recovered without any complications. The results were compared to a historical control group of patients who had the same surgical procedure by the same surgical team but without other interventions. Overall, recovery from pain and ability to return to daily activities appeared to be accelerated as a result of the therapeutic enriched bone-patellar tendon-bone transplant. The patient questionnaires and serial MRI scans of the knees following cell therapy were consistent with accelerated healing of the graft. Dr. Cugat and his team are obtaining one year follow up information on the treated patients and intend to report and publish these results in the near future.

ACL and meniscus tears are among the most common sports-related knee injuries and often are sustained simultaneously. According to the American Academy of Orthopedic Surgeons, ACL injuries have an annual incidence of more than 200,000 cases with nearly half undergoing surgical reconstruction. Further, an estimated 850,000 patients undergo surgical procedures to address meniscus injuries each year.
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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:

Cugat starts another meniscus study in Europe 10 Feb 2015 11:30 #3372

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Do you think we will get any information , news or results that are actually meaningful, instead of these pointless tidbits of information that do nothing to enhance shareholder value. Beyond just beginning to look like this company has been a fraud selling snake oil. Fed Up and pissed off. Whoever the new guy is in charge of IR obviously does not know what IR stands for as he does not return calls or e-mails. Wish I could wake up from this nightmare and have my lost money still in the bank. Fas expect any answers to your questions ?What's it been a year now ?
What's your buddy Dov have to say ?

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Cugat starts another meniscus study in Europe 14 Feb 2015 15:18 #3402

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Fas,

It seems the 20 patient study by Dr Cugat was just for fun! Now we are starting with a 60 patient PHASE I trial. Why is this study not a phase II trial? At this pace, the phase III trial should be completed in 2021....

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Cugat starts another meniscus study in Europe 14 Feb 2015 17:44 #3403

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DOV-

Yes- that was my first reaction too a few days ago.

They only plausible reason I came up with, was that ACL is the "big pop" when all four major tendons in the knee gets torn.

This study seem to deal with knee problems in general and also handles lesser serious issues.

Either that- or the "rules in Europe have changed" which I hope that have not. :really:

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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:

Cugat starts another meniscus study in Europe 14 Feb 2015 22:17 #3405

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Not only is it phase 1...why is it such a big phase 1 ? :bang:

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Cugat starts another meniscus study in Europe 15 Feb 2015 10:33 #3406

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I think the key here is that this is and "investigator initiated" open label study. It is not Cytori's study, although they are probably subsidizing its cost to some extent. Safety has already been demonstrated in much more complicated indications. Another example is how Athersys went DIRECTLY to Phase II on stroke, after demonstrating safety in other indication, with an allogeneic therapy. If Cytori felt this study was worth the investment at this time, with their limited resources, it would have been a Phase II. I think Mr. Cugat is simply trying to incorporate the therapy into his practice and that is why this is not phase II double blinded and placebo controlled. A low cost way to get more data. Just my hunch.

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Cugat starts another meniscus study in Europe 15 Feb 2015 11:19 #3407

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Yes- that all could play a role too.

Another issue is the population- The ACL clinic was done with professional athletes in their prime,

They heal differently than an average man/woman 50 years of age with a BMI of lets say 29 or so. :whistle:

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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:

Cugat starts another meniscus study in Europe 15 Feb 2015 14:54 #3408

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Whatever the motivation for the Cugat trial of 60 patients it still continues to be very positive in providing additional information about how ADRC facilitate healing in a difficult to treat indication. If he is incorporating the procedure in his practice and CYTX is subsidizing the cost that's OK with me as it indicates that Cugat sees this in a very positive light. Hopefully Cytori will have had a hand in the trial design so that the data conforms to a high standard for Registry purposes.

Lets not forget that the Scleroderma trial also came out of an "investigator initiated open label trial". :yep:

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Cugat starts another meniscus study in Europe 16 Feb 2015 09:43 #3415

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***Lets not forget that the Scleroderma trial also came out of an "investigator initiated open label trial".***

Lets not forget how LONG it takes for so few patients to be enrolled and then to hear the data and we are still some time before the next phase is complete and reimbursed. If we had revenues, real revenues I would be more agreeable on the subject but we have always been 6 months from BK in the 8 years I have been here and have about 2 months or less of available cash now.

BTW...this whole healing faster pitch may not fly with the general public. Think Swiss bone study. We need indications where ADRC's not only provide better healing but simpler, less invasive healing or even sole source of healing. Having to go through a full surgical procedure, same as always but adding some ADRC's (which means a additional lipo) just to save a few weeks recovery and maybe better healing isn't necessarily something the masses will clamor for let alone insurance companies wanting to pay for as necessary.

IMHO, 60 is a large number for "playing" for a near broke company to supplement and if the is a longer term plan they should have communicated it. :bash:

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