The Korean-based stem cell biotech, RNL Bio, which also does business in the U.S. as RNL Bio and Human Biostar Inc, reportedly (seems to be a press release, PR) has filed an investigational new drug (IND) application with the Korean FDA (KFDA). The purpose of the application is to test the efficacy of autologous adult stem cells for the treatment of cerebral palsy.
In the PR, it says the trial would treat up to 45 children using a product called RNL-AstrostemTM given intravenously (IV).
By way of background, cerebral palsy is a relatively common disease of brain injury in children, affecting about 3 kids out of a 1000. Stem cells have been proposed to treat this condition, but it is still early days in the investigation of this approach.
I found 12 clinical trials on stem cells and cerebral palsy, but only about half are actually related to this area of clinical investigation. Only one has results posted and it was an allogeneic trial. It suggested some subtle, transient (lasting a few months) improvement in function in transplant recipients. There was no clear evidence of an increase in major adverse events, which is good, but there was an increase in other adverse events. A limitation is that patients were only followed at most 6 months.
Getting back to RNL Bio, as evidence that the stem cell product is safe, the PR cites a RNL Bio paper that I felt, as a stem cell scientist, was relatively unconvincing as I discussed in a recent post (see here, the 4th paper discussed).
In today’s PR on the IND filing, Dr. JC Ra, leader of RNL Bio, is quoted:
“It is our mission to find cures for incurable diseases, such as the terrible pediatric curse of cerebral palsy, through autologous stem cell technology.”
RNL Bio has been in the news in the last year or so for a patient lawsuit filed in California, alleged smuggling of stem cells across international borders, and its legal conflict (both sued the other) with US partner Celltex.
Interesting side-note at the bottom of the article. I had never thought of “stem cell smuggling” being an activity that others participated in.
Here is an interesting follow up.
Why was someone with a degree in veterinary medicine involved in caring for a child with cerebral palsy?
http://www.healthintheglobalvillage.com/2013/02/12/rnl-bio-and-the-administration-of-an-unlicensed-stem-cell-based-medical-product-to-a-child-with-cerebral-palsy/
Old Southern Religious Right Winger’s……….hmm I would say that statement is sickening! Stereotyping and assuming if one is religous or from the South they are ignorant greedy buffoons. It is much more productive to stick to facts and leave out the personal slams. If you want to be credible and present a legitimate case for debate please don’t minimize your credibility by clouding it with personal beliefs that can be offensive to others.
Did you even click on the last link? There you will find all the “facts” you need.
Follow the money: A donation of $1M from Dr. Ra established the Bethesda Life Foundation, a 501 (c) 3 nonprofit organization in Franklin TN, USA.
http://www.prnewswire.com/news-releases/unprecedented-donation-by-korean-stem-cell-leader-dr-jeong-chan-ra-of-rnl-bio-announces-the-donation-of-90-of-his-wealth-169019986.html
He gets the tax break, and the money funds US patients (children) to go to Korea.
http://www.bethesdalife.org/index.php/howtoapply/20-sidebar-menu/57-moremiracle-2
The board members are old southern right wing religious GOP’ers that only want to make a statement about ESCR and know nothing about the science involved nor do they care about the children they are putting at risk. This is sickening.
Ah yes, the Dr. Ra delusional PR machine at work again. The last thing he foisted out was a Q&A on how he was so “honored” to be a nominee for the Nobel (cough).
That said, no one I work with in the Cord Blood industry or research (i.e. Duke, Northwestern, Harvard) is giving any scientific support to the poorly designed (arms) and non-replicable(wide age and number of subjects) studies on CP coming out of Korea.