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Author Topic: TissueGene-C articular cartilage regeneration studies  (Read 20549 times)

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Offline bananzaboy

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #15 on: October 30, 2012, 09:32:29 PM »
Hi Skierboy. Thanks for keeping us updated. Glad you are doing well. There is always something new to research!

Just came across this and thought it would be applicable to this thread rather than start a brand new one.

http://www.sciencedaily.com/releases/2012/10/121029154322.htm


Offline skierboy

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #16 on: March 12, 2013, 02:28:02 PM »
That Duke study is very positive.  Within the next 10 years we should be real improvement in cartilage regeneration as a viable alternative to knee replacement so long as the patient is not "bone on bone" already.

Now to report on my progress to date with TissueGene-C (TG-C):

I go in for my 18-month review of the TissueGene-C injection next week.  Overall I am very pleased with the results.  My ability to use my left knee has increased since my last exam six months ago.  I can perform some exercises involving the knee that I could not half a year ago and that I was no way able to do before I received the injection.  I haven't had to go in for any hyaluronic acid injections in the knee for the past 8 months and feel no need to do so now.  I used to have to get them every 6 months.

My biggest problem has been discovering that I have numerous bone spurs in the left knee joint that really limit doing anything "extreme" with the knee.  I attribute these spurs to the microfracture procedure performed on the knee about 4.5 years ago.  I knew within months after that procedure that I had developed a bone spur on the lateral side of the knee.  But it was not until the most recent X-ray of my left knee that we saw the other bone spurs in the joint.  When I first was examined to see whether I qualified for the TissueGene-C study 18 months ago, one couldn't see squat regarding lateral side of this knee--it looked like a cloud bank blotting everything out.  I assume that was the second-class cartilage that had been created by the microfracture procedure.  But a year later, we got a much clearer X-ray--which was additional proof to me that the TissueGene-C substance had done a lot to replace the weak second-class cartilage with real articular cartilage.  But that clearer image also disclosed the bone spurs lurking there.

Unfortunately the Korean product can't resolve bone spurs.  I may have them for life.  I've been doing a lot more swimming as a cardiovascular workout and very little cycling over the past 6 months.  But cartilage wise, that knee is much improved.

The latest press release by the U.S. company handling the FDA study is at http://www.tissuegene.com/news/releases.html.  They seem to be making slow but steady progress toward getting FDA approval for single-injection use of the product.  My understanding is that they want that ASAP to get some initial return on investment while they forge ahead with testing of multiple-injection trials that will likely begin sometime later this year.  Enrollment in the Phase II study is now closed.  Your best bet is to wait till they announce the Phase III study and volunteer, though I assume 1/3 of the participants in that may receive a placebo, just as was done for the Phase II.  But maybe not.

I'll have to check through this KneeGeeks site to see if there are any good approaches to removing bone spurs, but the little I've heard thus far does not make me optimistic.   :'(  But that's a secondary concern compared to my knee arthritis over the past decade.  So overall, I'm in a good frame of mind.   :)
Nov 04 -- LK debridement
Sep 08 -- LK microfracture
May 11 -- RK meniscus trim
Sep 11 -- LK TissueGene-C injection

Offline mccartjt

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #17 on: February 12, 2014, 10:39:15 PM »
Skierboy

Thanks for your updates below. I just emailed Tissue Gene to see if they have any more updates on this. It would be heaven to be able to go for a run with decent knees! Anyway my back isn't too clever either. The faster the medical industry can get answers to joint problems so much the better for us all be it discs in the back or cartilage in the knee.

Do post back and let us know how you are getting on. As far as your bone spurs go I am sure at some stage they could be removed and then a new injection of the material to completely fix your issues maybe a course of action?

JM

Offline MDAL

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #18 on: February 14, 2014, 09:41:38 PM »
I certainly hope that if this is true and not another BS, it comes to the market soon!

Link:

http://www.clinicaltrials.gov/ct2/show/NCT01221441?term=NCT01221441&rank=1

Offline MDAL

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #19 on: March 04, 2014, 08:08:08 PM »
There seems to be something going on with this. In china they came up with something that also works through TGF-β1, only different methodology than TissueGene-C

http://ryortho.com/breaking/hydrogel-plus-stromal-cells-repairs-cartilage/

I am always a bit skeptical with these things, but there is some level of replication around... Let's hope so.
« Last Edit: March 04, 2014, 08:13:30 PM by MDAL »

Offline mccartjt

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #20 on: February 10, 2015, 02:26:46 AM »
That Duke study is very positive.  Within the next 10 years we should be real improvement in cartilage regeneration as a viable alternative to knee replacement so long as the patient is not "bone on bone" already.

Now to report on my progress to date with TissueGene-C (TG-C):

I go in for my 18-month review of the TissueGene-C injection next week.  Overall I am very pleased with the results.  My ability to use my left knee has increased since my last exam six months ago.  I can perform some exercises involving the knee that I could not half a year ago and that I was no way able to do before I received the injection.  I haven't had to go in for any hyaluronic acid injections in the knee for the past 8 months and feel no need to do so now.  I used to have to get them every 6 months.

My biggest problem has been discovering that I have numerous bone spurs in the left knee joint that really limit doing anything "extreme" with the knee.  I attribute these spurs to the microfracture procedure performed on the knee about 4.5 years ago.  I knew within months after that procedure that I had developed a bone spur on the lateral side of the knee.  But it was not until the most recent X-ray of my left knee that we saw the other bone spurs in the joint.  When I first was examined to see whether I qualified for the TissueGene-C study 18 months ago, one couldn't see squat regarding lateral side of this knee--it looked like a cloud bank blotting everything out.  I assume that was the second-class cartilage that had been created by the microfracture procedure.  But a year later, we got a much clearer X-ray--which was additional proof to me that the TissueGene-C substance had done a lot to replace the weak second-class cartilage with real articular cartilage.  But that clearer image also disclosed the bone spurs lurking there.

Unfortunately the Korean product can't resolve bone spurs.  I may have them for life.  I've been doing a lot more swimming as a cardiovascular workout and very little cycling over the past 6 months.  But cartilage wise, that knee is much improved.

The latest press release by the U.S. company handling the FDA study is at http://www.tissuegene.com/news/releases.html.  They seem to be making slow but steady progress toward getting FDA approval for single-injection use of the product.  My understanding is that they want that ASAP to get some initial return on investment while they forge ahead with testing of multiple-injection trials that will likely begin sometime later this year.  Enrollment in the Phase II study is now closed.  Your best bet is to wait till they announce the Phase III study and volunteer, though I assume 1/3 of the participants in that may receive a placebo, just as was done for the Phase II.  But maybe not.

I'll have to check through this KneeGeeks site to see if there are any good approaches to removing bone spurs, but the little I've heard thus far does not make me optimistic.   :'(  But that's a secondary concern compared to my knee arthritis over the past decade.  So overall, I'm in a good frame of mind.   :)

Skierboy

Do you have any updates on this procedure?

Thanks

JM

Offline MDAL

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #21 on: February 10, 2015, 09:17:11 PM »

Skierboy

Do you have any updates on this procedure?

Thanks

JM

JM:

He is not too active in the forums. He has his email posted in one of his posts (you can look). I once emailed him to know how things were going and he was kind enough to answer back with a lot of extra and detailed information. He said back then that things were still improving.

Perhaps you can email him, since he is not too active in the forums.




Offline Sturge08

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #22 on: October 29, 2015, 03:10:02 PM »
These results show some promise

http://www.tissuegene.com/download/TGI%20Present%20PII%20Data%20ICRS%20and%20ASGCT.pdf

Data Presented at the World Congress of the International Cartilage Repair Society and the American Society of Gene & Cell Therapy
Rockville, Md. May 11, 2015 – TissueGene Inc. is pleased to announce that Dr. Moon Jong Noh, VP of Research & Development, will present phase 2 clinical data for TG-C at both the 12th World Congress of the International Cartilage Repair Society (ICRS) and the 18th meeting of the American Society of Gene & Cell Therapy (ASGCT). Dr. Noh presented a poster at ICRS on Saturday May 9th, and he will follow with an oral presentation at ASGCT on Friday May 15th.
TG-C is an allogeneic (donor) cell therapy involving human chondrocytes (cartilage cells) that have been genetically modified to produce the therapeutic growth factor TGF-ß1 and has been developed to induce cartilage regeneration in patients with osteoarthritis. In a primary analysis of the phase 2 clinical study results, TG-C showed a statistically significant improvement over placebo in the change from baseline in both pain (VAS) and function (IKDC) scores. The MRI analysis showed cartilage regeneration evidence in selected TG-C treated patients. On the basis of this compelling phase 2 data, TissueGene is preparing to initiate phase 3 trials of TG-C in patients with osteoarthritis of the knee.

Offline Sturge08

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #23 on: October 29, 2015, 03:13:08 PM »
http://www.tissuegene.com/download/TGI%20Announces%20SPA%20Agreement%20with%20FDA%20for%20PIII%20clinical%20trial%20of%20Invossa.pdf

ROCKVILLE, MARYLAND, May 15, 2015 -- TissueGene, Inc. announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design, endpoints and statistical analysis plan for a Phase 3 clinical trial for InvossaTM, an allogeneic cell therapy for osteoarthritis of the knee. There are an estimated 9 million Americans suffering from osteoarthritis of the knee, one of the leading causes of disability in the United States.
As noted by the FDA in its May 15, 2015 letter to TissueGene, “[W]e have determined that the design and planned analyses of your study sufficiently address the study objectives and this study is adequately designed to provide the necessary data that, depending upon outcome, could support a license application submission for drug approval.”
This double-blinded randomized controlled trial will enroll approximately 1,020 patients with osteoarthritis of the knee. Patients will receive an injection of either InvossaTM or a placebo. The trial is designed to evaluate improvement in knee function and pain and perhaps most importantly, disease modification as measured by joint space width. As per the SPA, the Company plans to use data from the trial as the basis for submission of a Biologics License Application (BLA) for InvossaTM. Subject to BLA approval, InvossaTM would be the first disease modifying osteoarthritis drug (DMOAD) marketed for the treatment of osteoarthritis of the knee.
Mr. Woosok Lee, President and CEO, commented, “The SPA agreement is a major milestone for us as it represents the first clearly defined development and regulatory pathway for the approval of InvossaTM for the treatment of osteoarthritis of the knee. As we've mentioned previously, reaching agreement with the FDA on the SPA was our number one priority. "We look forward to initiating this trial as soon as possible and are excited to continue to work with all of the parties that have and will be instrumental in our development of this important cell therapy product."
Phase 3 data from a separate clinical trial in Korea by TissueGene’s licensee, Kolon Life Science, Inc, is expected in September of 2015 with BLA submission to the Korean Ministry of Food and Drug Safety (MFDS) by later this year. “We anticipate commercialization of InvossaTM by early next year in Korea and look forward to its expansion in the Asian market,” said Mr. Lee.

Offline Sturge08

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Offline skierboy

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #25 on: June 13, 2017, 12:01:13 PM »
The TissueGene material worked well for approximately 5 years.  Then there was pretty rapid deterioration of the cartilage in that knee.  I had a total knee replacement (TKR) done on April 24th of this year.  By that point I was apparently bone on bone and had not been walking with a totally straight leg for some months.  My PT now includes stretching out the Achilles tendon and hamstring so that I can walk with full extension of the leg again.  I was told that many other of the TissueGene study participants had likewise noticed significant deterioration in their condition after 4 or 5 years.


The TissueGene study did give me 5 additional years of original left knee use, so I'm happy for that extra time.  But notwithstanding the mental hesitation of going the TKR route, it's clear that had become the clear path forward.  I now see a number of neighbors and friends who have not been able to make the decision to get a knee replacement, and they are suffering because of that.  By the time they make the decision to have the problem knee replaced, they may not be able to regain total functionality in the joint and may also have done permanent damage to other parts of their bodies due to compensating for the bum knee for so long.


Unfortunately there is no "bright line" for when to go the knee replacement route.  In my case the train appears to have begun leaving the station, but I was able to hop on board w/o too much damage due to my somewhat delayed response in arranging for the replacement.  For others I see, the train is well out of the station at this point and gaining speed.


My orthopedic surgeon (who performs over 250 TKRs each year) says that 90 percent of his knee replacement patients are still satisfied with their replacement knees 20 years after the operation.  Their shelf life depends in large part on how strenuously they are used once installed.  I expect this knee will last as long as I'm around to use it.


Good luck in your journey!
Nov 04 -- LK debridement
Sep 08 -- LK microfracture
May 11 -- RK meniscus trim
Sep 11 -- LK TissueGene-C injection

Offline neptronix

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #26 on: April 18, 2018, 04:31:36 PM »
Hey, thanks for the update, and your initial post many years ago.

I am a 36 year old with knees in very bad shape, and counting down the years before i am basically disabled.
TKR would be very unwise at this part of my life. I would rather live in a wheelchair and wait for stem cells or growth factors to provide a cure.

I don't meet the criteria for these clinical trials because i am below 40..

Been reading about growth factor drugs, both the tissuegene one, as well as the one merck is working on, and it's super invaluable to find at least ONE report from a clinical trial.

5 years is a long time to have your natural knees still work, from a shot. I wonder what repeated administration would do. I'm really looking forward to these drugs hitting the market in the next few years. Thanks for providing me some hope.















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