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Author Topic: TissueGene-C articular cartilage regeneration studies  (Read 20567 times)

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Offline skierboy

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TissueGene-C articular cartilage regeneration studies
« on: October 25, 2011, 11:02:40 PM »
I am participating in a Phase II FDA-monitored study of an investigational product called TissueGene-C.  It, like numerous other products currently under review, is intended to regrow that great articular cartilage that we all had when younger and before we were hit with osteoarthritis.  But unlike products like Denovo ET and NT, it is give to the patient through injection and not through surgery followed by months of PT.

Having gone through a reasonably successful microfracture procedure on my left knee three years ago, plus a month plus of PT and use of crutches, the simplicity of the TissueGene-C approach raises great scepticism in me. It can't be that easy.  And there are certainly a lot of ineffective (if not bogus) alleged stem cell injection procedures available around the country and the world today that one should steer away from.  The jury is still out (and will be out for several more years) on whether TussueGene-C will get FDA approval as a medically acceptable method of addressing knee osteoarthritis.  But somebody (possibly a group of venture capitalists) is putting up a lot of money to test the material, looking ahead to possible FDA acceptance.

Rather than giving you a lot of background on the product, here are a couple of web sites that can do so:  http://www.tissuegene.com/
http://www.kolonls.co.kr/english (the home web site of Kolon Life Science, Inc.)

For some reason I can't reach the Kolon web site today, though I have accessed it several times in the past.  To make a long story short, Kolon Life Science in Korea and TissueGene, Inc. in the U.S. are running parallel clinical trial series to see if they can get regulatory approval for the TissueGene-C product in their respective countries.  I've heard rumors as to where the original human chondrocytes came from that form the basis for the several separate tissue-regenerating products that the companies are now testing.  But their origins are not as important as whether they in fact work.

The TissueGene, Inc. web site has a nice page showing where several products are in the regulatory approval pipeline.  The TissueGene-C product is the furthest along in the testing, the others still being back in animal studies, it appears.

A friend who was scheduled for a total knee replacement volunteered for the Phase I study about 18 months ago.  He received the TissueGene-C injection, and 4 weeks later he had his knee replaced.  Everyone enrolled in that first human study in the U.S. had to be already scheduled for knee replacement.  The point was that when the knees were cut into, the orthopedic surgeons could see and document whether the TissueGene-C material was in fact acting in a way that would lead to possible articular cartilage generation down the line.  Apparently the Phase I results were positive enough that the biotech companies involved determined that it was financially sensible to move on to the Phase II clinical trials.

That's what I'm participating in.  The biggest difference between the two phases is that in this trial, the participants get to keep their knees!  In this phase the testers carefully monitor the participants' medical condition for at least a year following the injection of the material.  We fill out lengthy written evaluations on our levels of knee pain/discomfort in doing a wide range of activities.  Over time, the hope is that most of those who received the product will report that their knee pain/discomfort has diminished and thus their osteoarthritis problem has been to some measure resolved w/o the need for knee replacement.  If the results of this study are positive enough, there will be a Phase III clinical study which (perhaps among other things) will allow for the injection of the product multiple times over, say, a year, to see whether (I guess) enough articular cartilage can be created at the site of the cartilage defect to fill the hole and render the patient essentially good as new.

One of the requirements of the FDA under this study is that there must be a blind control group that receives a placebo injection rather than the key product.  That's one of the key ways the FDA has of judging just how good (or not) a new product or procedure may be.  I THINK I got the real product, but neither the nurse I work with nor the overseeing orthopedic surgeon know for sure themselves who gets what.

It's only been about 6 weeks since the injection, and it's too early to tell whether there has been a turn for the better in my osteoarthritis.  There have been other factors (not worth mentioning here) that have made my left knee either better or worse during the period and that have nothing to do with the injected material.  Guess that's why one needs a fair number of participants in these clinical trials to be able to average out all the individual dips and ascents of people so that one can see whether, taken as a whole, the group is improving or not.

Those handling the Phase II clinical trials are still seeking volunteers to participate.  I'm in the Northern Virginia area. Commonwealth Orthopedics in Arlington, Virginia is providing the medical oversite for our cadre of study participants.  See http://www.c-o-r.com/location_office_arlington.asp.  One has to be determined to have Level 3 osteoarthritis of the knee in order to participate.  The orthopedic surgeon makes that determination after X-rays are taken of your knee(s).  If accepted into the study group, you have to have several MRIs over the study year and make about 10 visits to the hospital office to do the routine evaluations, have blood taken, etc.  Basically all the medical costs associated with the study are picked up by the company.  There is zero out-of-pocket cost except whatever time it takes for the appointments.

There is a small clinical testing company that does the initial screening of possible participants before Commonwealth Orthopedics gets involved.  If anyone thinks they may qualify, thinks they may like to participate and would like that contact information, let me know  by an email off line.  I'll try to post reports back here over the next 11 months or so regarding how my knee is faring during the trial period.
Nov 04 -- LK debridement
Sep 08 -- LK microfracture
May 11 -- RK meniscus trim
Sep 11 -- LK TissueGene-C injection

Offline SW71

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #1 on: October 30, 2011, 10:03:25 AM »
Thanks skierboy for sharing this with us. This is a novel approach to cartilage repair, at least it is for me in anything I've read before.

Here's a few references with a little bit more info about the approach of using gene therapy to repair cartilage

http://www.ncbi.nlm.nih.gov/pubmed/15738684
http://www.ncbi.nlm.nih.gov/pubmed/21674822
http://www.ncbi.nlm.nih.gov/pubmed/18313477
http://www.ncbi.nlm.nih.gov/pubmed/15738684
http://www.ncbi.nlm.nih.gov/pubmed/11560773

Good luck in your trial. Hope you're in the treatment group and not the control group!
1984 L patello-femoral recon
1985 R patello-femoral recon
2005 R TTT + LR
2006 L TTT + LR
2011 Grade IV retro patellar lateral trochlear chondral defects, currently using PRP

Offline skierboy

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #2 on: December 15, 2011, 11:04:29 PM »
I just went in for my 3 month visit after receiving the TissueGene-C material early in the fall.  The difference in my left knee's condition now is remarkable.  About after two months after the injection I started noticing improvement in various things that I could do with this knee that had been difficult if not impossible for months before.  While I'm still somewhat slow in descending stairs, I can now do so w/o having to hold the railing.  There is much less inflammation and pain associated with that feat.  I barely notice the knee at all now when climbing stairs.

I cycle to and from the office much of the time.  I've noticed that I'm biking noticeably faster than I did for the past two years, which has to be due to the reduction in knee pain and the related increase in power in my left leg.  Bending down to pick up items from the floor is still a bit of a feat, but I can do it now w/o much discomfort, though things like that work better in the morning than in the evening when I've been using the leg for the full day.  I still can't bend my left leg fully back--not by a long shot.  But after two surgeries on this knee, that is hardly surprising.  It is the general reduction in pain, inflammation, and discomfort that are the main benefits of the Tissue-Gene-C material.  It's not going to return you joint-wise to being a 20-year old again.  What it has done thus far in terms of reducing the effects of my Level 3 arthritis is remarkable enough, especially since it did not require any surgery.

The research cohort that I am a part of in Arlington, VA still has about 4 slots left for new study participants.  If you are in the geographic area and want to be considered for the program, send me an email to [email protected]  I can then send you the information on who to contact.  Remember, however, that 1 out of every 3 people receive a placebo material, not the true Tissue-Gene material.  Those involved in administering the material and in tracking the results do not know themselves which study participants are in which group.  But if you've got a failing knee, odds of 2 out of 3 are far better than 0 out of 3.

While I'm pretty certain that I am NOT in the placebo group, if I should be, then if a placebo could make me feel this good, all the better!   :)

In sho
Nov 04 -- LK debridement
Sep 08 -- LK microfracture
May 11 -- RK meniscus trim
Sep 11 -- LK TissueGene-C injection

Offline SW71

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #3 on: December 31, 2011, 10:31:25 AM »
Thanks Skierboy for keeping us updated on your progress. Sounds like good progress for you. Three months isn't that long so hopefully the progress continues
1984 L patello-femoral recon
1985 R patello-femoral recon
2005 R TTT + LR
2006 L TTT + LR
2011 Grade IV retro patellar lateral trochlear chondral defects, currently using PRP

Offline bananzaboy

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #4 on: January 06, 2012, 08:46:00 PM »
This certainly looks promising and they (Tissuegene/Kolon) obviously have high hopes for it. Long-term safety may be the big Qu but some of us obviously won't be able to wait.

I have found a few useful links on the net. If all goes according to plan they are hoping to launch in Korea in 2014 then in the US in 2015. A conservative price they are quoting is $3000 per treatment.

However a lot could go pear-shaped between now & then which could mean it doesn't make it to market. Let's stay positive though.

Skierboy- great to hear you are deriving benefit from this & as SW71 says please keep us updated.

http://oba.od.nih.gov/oba/RAC/meetings/Mar2010/Mont_1016.pdf

http://www.kolonindustries.com/Eng/MalgumBoard/DownLoad.asp?sFileName=20110805_+Mirae+Asset.pdf&sFilePath=/upload_files/MalgumBoard/analystreporteng/2011/08


Offline Sturge08

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #5 on: January 10, 2012, 01:49:59 PM »
After reading the same pdf, i was under the impression that it would be released in Korea in 2013, not 2014. What are the chances of it coming to Europe before US? What would the possibilities be in going to Korea to have the treatment. Anyone got any ideas?

Offline skierboy

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #6 on: March 08, 2012, 10:11:51 PM »
I'm reporting in after 6 months with the TissueGene-C regenerative cartilage material in my left knee.  I'm doing fine and my knee has continued to improve ever since about 6 weeks after the original injection.  I can once again bike w/o any noticeable discomfort, and I know that my biking speed has increased since the low days when biking was pretty depressing due to the constant knee pain.  I go in for my 6-month MRI and general check-up tomorrow.

Thanks to thev previous writer who tracked down a couple of reports on the product that I was not aware of.  It is good to hear that the company plans to make the product available in Korea and in the U.S. in the 2014-2015 time frame.  All of this assumes that the TissueGene-C product gets FDA approval (and approval from the Korean equivalent of the FDA).  I had understood that the product would undergo several years of Phase III studies before it would get the green light from FDA.  It would be great if the results of the Phase II study are so positive that any requirement for Phase III testing is waived.

There is a mention of a projected cost of $3000 for single injections when the product goes public.  That's presumably the cost of the product itself and not the doctor's cost in administering the injection, etc.  But compared to knee replacement or the microfracture procedure I had on that knee about 4 years ago, it's a highly reasonable price.  And the "recovery" time one would measure in weeks and not months.

I am not certain whether new patients are still being accepted into the clinical study group based in Arlington, VA.  Those interested in finding out could call Deborah Tominack, RN at 703-863-5007.  If you do sign up to participate, however, do remember that 1/3 of the study participants receive a placebo injection rather than the real stuff.  Double blind tested, etc., etc.  But figure it's all for the betterment of medical science, and your children and/or siblings will benefit from bringing new products to the market that obviate the need for cutting out your knee and replacing it with a metal and plastic joint.
Nov 04 -- LK debridement
Sep 08 -- LK microfracture
May 11 -- RK meniscus trim
Sep 11 -- LK TissueGene-C injection

Offline Sturge08

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #7 on: March 09, 2012, 10:36:35 AM »
Skeirboy, this sounds amazing, will you report back with your mri results and general check-up. Lets hope its a winner and the 7 years of phase III testing does get waivered. Have you experienced any side effects? I guess at this point, will still don't not what you were injected with. Please keep us all updated.

Offline mccartjt

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #8 on: March 11, 2012, 02:57:42 AM »
Sturge08

Just remember that this isn't autologus but an allogenic (donor) injection. That it works is wonderful. However do you want an Allogenic injection with the risks that go with this? There is (an albeit) a slim chance that you only need one scary thing like having a dormant CF gene and a dormant CF gene in the allogenic injection then you may have Cystic Fibrosis sufferer!

I am not a medical professional (and I don't know all the bad permutations) but crazier things in life have happened..

You can read a little about GVHD or Graft versus Host Disease here

http://www.regenexx.com/2012/03/cellsdrugs-takes-a-scientific-hit/
« Last Edit: June 26, 2012, 12:35:27 AM by mccartjt »

Offline skierboy

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #9 on: April 29, 2012, 01:36:46 AM »
O.K., the 6-month exam and all went very well for me.  The orthopedic surgeon monitoring my progress seemed pleased.  In the month since then, the knee has continued to improve.  My main complaint (which has nothing to do with the TissueGene-C injection) is that I have to be careful in any unusual movement with my left leg since I grew a lateral side bone spur down at the end of the femur due to the microfracture procedure I went through several years ago.  I have learned through practice what types of movements tend to make a key ligament or whatever "twang" over that bone spur, so I simply avoid those movements.

I suspect that my left knee is stiill a bit weaker than my right, but consider how widely different they were 7 months ago, it's like night and day.  I can even (with some care) rise from a hands-and-knees position to upright by using primarily my left leg--something I couldn't hope to do six months ago.  I don't notice any real difference between the two when cycling now--again a world of difference from half a year ago.  And this was all the result of a single injection of the TissueGene-C material.  I could not be more pleased!

One reality check here, though.  When I went in for my 6-month review, I learned that the Phase II study of the material had been temporarily suspended due to the fact that the Phase II study protocol had not indicated anything about initial heavy inflammation in the joint within a few days following the injection.  I had that happen to me, and from what I understand, virtually everyone has had the same reaction.  Thus it apparently is occurring for those in the placebo group as well as those receiving the real substance.  As a result, the FDA has restricted the sponsors of the study from enrolling any additional people till it does a thorough review of things.  I heard from one medical person involved with the study that the inflammation might be due to the medium in which the dose is delivered, since apparently this material is different from what was used for the patients involved in the Phase I study.  BTW, the inflammation post injection was, in my case, treated by the orthopedic surgeon by a short treatment with a strong prescription anti-inflammatory.  That did the trick, and the iinflammation went down quickly and has not returned.

I have started some hyaluronic acid injections into the knee beginning last week.  I used to get those injections (3) every six months since my left knee would kind of "dry out" and become painful and more difficult to bend after half a year.  But the need for the injections now is pretty minimal.  I was feeling a bit of tightness in the knee some weeks ago and thus figured it was time for a little local lube.  But by the time the product arrived (Euflexxa--NOT Synvisc!), the knee felt pretty normal again.  But I'm getting the injections anyway--spread over several weeks.  Clearly the frequency with which I need to get these seems to have extended from 6 months to about 8, and at least thus far the triggering symptoms are far milder than I had in the past.

Sounds to me that the approval for this product will likely occur first in South Korea rather than here.  If I felt I needed another injection, I'd consider flying there.  But for the moment one injection has done so much good that I might get by O.K. with only one.  Time will tell.  BTW, my impression is that the company is hoping to get U.S. FDA approval for single injections for TissueGene-C to arthritic knees even before its Phase III (multiple injections study) is completed.  This makes sense from a financial perspective.  Gives the investors an earlier return on investment.  And even if multiple injections are ultimately shown to be a wonderful cure for osteoarthritis, it doesn't mean that giving patients single injections doesn't do a lot of good.

My main concern now is that one limit I didn't realize on the TissueGene-C Phase II study group is that they are not accepting anyone over 70 into the program.  That is a later cut-off date than under many osteoarthritis study groups, but I'm now well into my 60s and I worry that I may hit 70 and find that this (apparently) great product is no longer approved for me.  Technically I know of no reason why it shouldn't be available since the age or youth of the recipient would seem to be irrelevant--unlike many other cartilage regeneration products where success is dependent upon the patient being young enough that he/she has plenty of stem cells that can be harvested, grown, and reinjected.

Enough for now.
Nov 04 -- LK debridement
Sep 08 -- LK microfracture
May 11 -- RK meniscus trim
Sep 11 -- LK TissueGene-C injection

Offline Sturge08

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #10 on: May 02, 2012, 11:23:10 AM »
At this stage do you now know if you had a dummy injection or the real deal?

Offline skierboy

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #11 on: June 13, 2012, 11:02:46 PM »
Sturge08--

In these clinical studies the participants are never actually told which product they received--the real item being tested or a placebo.  Even the medical personnel administering the materials don't know.  The medical team directly supporting the funders of the study do know, and all the results are fed to the FDA.  I have one friend who joined the study and who reported to me after several months that he noticed no real improvement in his knee--though he did have the additional inflammation following the injectionlike all the other participants seem to.  So I can only conclude that he received a placebo dose.  Either that or only a certain percentage of osteoarthritis sufferers respond positively to the TissueGene-C material.  But for whatever reason, I have responded well to the material.  If this is a mind-over-matter thing, guess I better change my faith to Christian Scientist. (:-))

Approaching month 9, and all is going well. . . .
Nov 04 -- LK debridement
Sep 08 -- LK microfracture
May 11 -- RK meniscus trim
Sep 11 -- LK TissueGene-C injection

Offline Sturge08

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #12 on: June 13, 2012, 11:20:37 PM »
at what point in time will you be told if you were administered the real deal or the placebo?

Offline bananzaboy

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #13 on: June 13, 2012, 11:45:39 PM »
Double blind placebo controlled. Sounds like it is a good study design so resulting data may be more robust.

Skierboy did they mention to you when the Phase II is due to end and the results will be published?

Offline skierboy

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Re: TissueGene-C articular cartilage regeneration studies
« Reply #14 on: October 28, 2012, 06:54:27 PM »
I suspect that the Phase II study will conclude sometime within the next year.  My impression (only an impression) is that they will then try to get FDA approval for single-injection Tissuegene-C treatment as a usual and customary practice (so it will qualify for coverage by medical insurance policies).  At the same time they will urge the FDA to authorize the Phase III study of Tissuegene-C, which will permit several injections of the material in the same patient.

My present left knee problems appear to have nothing directly to do with Tissuegene-C.  I passed the 12-month review point.  On the cartlidge front, all seems to be going well--except for newly discovered bone spurs in my knee.  I assume the we're caused by my microfracture procedure four years afo or by irritation from the knee arthritis in general.  In any case, it keeps the left knee from bending well, and there is associated discomfort.  Guess it gives me something new to research in this site!
Nov 04 -- LK debridement
Sep 08 -- LK microfracture
May 11 -- RK meniscus trim
Sep 11 -- LK TissueGene-C injection