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Author Topic: Tissuegene Writeup for Use of Gene Therapy for Cartilage Regeneration  (Read 5863 times)

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Offline yorkere

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I'm new to this List; thought I'd provide some very interesting information.....as shown below:

Local Firm Develops Gene Treatment for Arthritis, The Korea Times (Seoul, S. Korea), 19 Jun 2001.

Kolon Industries announced yesterday that it has developed the first-ever gene treatment for retrogressive arthritis.

According to the local firm, Tissuegene Co., a Maryland-based venture company, developed a gene treatment named ``Tissuegene,'' and acquired a patent from the United States authorities. The new material reportedly can recover damaged articular ligaments and cartilage through a re-combination of genes.

Kolon has a more than 50 percent stake in the U.S. venture company.

Under the technology, doctors put curer genes into chromosomes and mass- produce cells.

``We are in consultations with the U.S. Food and Drug Administration (FDA) for the approval of the new medicine,'' said Song Sun-moo, a managing director of the company.

``It will undergo clinical testing on local patients as early as late next year, and be commercialized around 2005,'' he added. It is also expected to help cure diseases involving the spine and peripheral nerves. Meanwhile, a recent tally showed that, each year, an additional 6,600 patients suffer from arthritis.


Update


HighBeam Research
Title: TissueGene Initiates Phase I Clinical Trial With TG-C

Date: 7/24/2006; Publication: PRNewswire;

 
GAITHERSBURG, Md., July 24 /PRNewswire/ -- TissueGene, Inc., a privately- held biopharmaceutical company advancing a pipeline of promising regenerative medicine therapeutics, announced today the acceptance of the Company's Investigational New Drug application (IND), and for the initiation of its Phase I clinical trial evaluating a single dose of TG-C for the treatment of degenerative joint diseases. This clinical trial is designed to assess the safety of TG-C in patients who have opted for total knee arthroplasty.
TissueGene has developed TG-C to regenerate cartilage in patients suffering from degenerative arthritis and more specifically for indications such as osteoarthritis of the knee. As an alternative to other methods of cartilage repair, TG-C will involve minimally invasive injections versus a surgical approach. Other techniques currently involve multiple and often invasive surgical procedures and have mixed results.
"We are pleased with the approval to start our Phase I program with TG-C and feel that our drug candidate has the potential to be not first-in-class, but also best-in-class," stated Dr. K.H. Lee, President, founder and Chief Executive Officer of TissueGene.
About TissueGene:
TissueGene, Inc. is a privately-held biopharmaceutical company developing a pipeline of promising regenerative medicine therapeutics in the field of cell-mediated therapy, and has several related products in development for the treatment of degenerative diseases. TissueGene is focused on harnessing the power of well-known, safe and effective growth factors combined with the dynamic regenerative capacity of mammalian cells to develop state of the art therapeutics.
For additional information on the company please visit http://www.tissuegene.com/ .
TissueGene, Inc.
CONTACT: J. Kelly Ganjei, Vice President of Business Development ofTissueGene, Inc., 301-921-6002, [email protected]
Web site: http://www.tissuegene.com/
Copyright 2006 PRNewswire
This material is published under license from the publisher through YellowBrix, Alexandria, Virginia. All inquiries regarding rights should be directed to YellowBrix.

This document provided by HighBeam Research at http://www.highbeam.com


Note:  Apparently the protocol is a direct injection into the joint space....



Offline skierboy

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Re: Tissuegene Writeup for Use of Gene Therapy for Cartilage Regeneration
« Reply #1 on: October 25, 2011, 09:50:53 PM »
Fast forward to October 2011.  TissueGene-C is now in Phase II clinical trials under FDA protocols.  I'll try to do a more complete write-up of the current study (in which I am participating) in a separate posting.  While it is administered through an injection into the joint area, the key thing is that is a method of cartilage regeneration, not simply a method for easing osteoarthritis pain like hyaluronic acid substances or artificial cortisone shots.  Thus the subject should more appropirately be discussed under the topic of cartilage regeneration.
Nov 04 -- LK debridement
Sep 08 -- LK microfracture
May 11 -- RK meniscus trim
Sep 11 -- LK TissueGene-C injection

Offline Honeybunch

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Re: Tissuegene Writeup for Use of Gene Therapy for Cartilage Regeneration
« Reply #2 on: January 04, 2012, 09:15:40 AM »
does that mean it would work for menisci

Offline Affliction79

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Re: Tissuegene Writeup for Use of Gene Therapy for Cartilage Regeneration
« Reply #3 on: April 08, 2012, 07:55:16 PM »
I am very intrigued by this. If it can rebuild cartilage, I would say there is a good shot it would help with Meniscus.

Offline skierboy

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Re: Tissuegene Writeup for Use of Gene Therapy for Cartilage Regeneration
« Reply #4 on: March 12, 2013, 01:57:30 PM »
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.

On the meniscus issue that was discussed in the more recent postings, my impression (based on my knee) is that meniscus tissue is also improved by TG-C. 
Nov 04 -- LK debridement
Sep 08 -- LK microfracture
May 11 -- RK meniscus trim
Sep 11 -- LK TissueGene-C injection















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