By Brett Dalton, “Local man to receive stem cell therapy”, The Pittsburg (Ks.) Morning Sun, October 24, 2009, © 2009 GateHouse Media, Inc.

By Elizabeth Shaw, “Paralyzed teen racer traveling to Portugal for stem cell therapy”, September 4, 2009, © The Flint Journal

One of the companies/clinics we missed when compiling the Global Guide to Stem Cell Treatment Providers this summer is a South Korean firm with an expanding research, manufacturing, and stem cell processing presence here in the United States.

RNL Bio of Seoul offers stem cell treatments at clinics in Korea and China. So far we haven’t been able to get any information about costs. And we can’t find any scientific evidence that their treatments work. But we’ll keep asking.

The company claims to have successfully cloned pet dogs – it advertises its services in that area on its Korean Web site – and to have treated dogs and cats with spinal cord injuries using stem cells.

The company also says it has successfully treated atopic eczema and rheumatoid arthritis in humans using fat-derived stem cells, and has begun testing treatments for osteoarthritis and Buerger’s disease, a painful inflammatory disease of veins and arteries that is associated with smoking.

In addition, the company conducted three years’ worth of safety and efficacy tests in animals on a stem cell-based treatment for spinal cord injury. The tests were apparently very encouraging, according to the company.

“Our stem cell therapeutics involves no immune rejection because the stem cells are exactly patients own,” said CEO Dr. Jeong-Chan Ra in a statement released April 30, 2009. “Our adult stem cell has no tumorigenicity activity at all, while embryonic stem cell faces high risk of it. We have developed safest therapeutics to help devastated patients with incurable diseases.”

The big news now is that the company says it has received permission from the Korean FDA to launch a Phase I clinical trial using its fat-derived stem cells to treat spinal cord injury.

Assuming that’s true, it would trump Geron Corporation, which has been planning a Phase I spinal cord injury trial for years. Unfortunately, the U.S. FDA recently clamped yet another clinical hold on the trial, which was supposed to be launched this summer, while it looks at some additional data from animal tests. It was the second hold the FDA placed on Geron’s trial. The first, in May 2008, was lifted in May of this year.

Whether the Korean FDA is as meticulous and stringent as the U.S. FDA in its monitoring of proposed clinical testing is a question we can’t answer here. But we do hope so.

RNL Bio of Seoul was founded in 2000 by Jeong-Chan Ra and three professors from Seoul National University and was listed on the Korean stock exchange (KOSPI) in 2005.

Its affiliate clinic in China, RNL Joyang Regenerative Medical Clinic (Yanji) claimed recently (June 2009) that it cured a patient’s atopic eczema using adult stem cells derived from fat tissue.

The company is also affiliated with the Tiantan Puhua Hospital in Beijing, China, and the Sunrise Center for Regenerative Medicine, also in China.

The company says on its Web site that it has signed “memoranda of understanding” with The Johns Hopkins University (U.S.) and Newcastle University (U.K.) for stem cell research and therapy development.

The other big news is that the company’s U.S. subsidiary, RNL Biostar, is opening a research lab and stem cell factory in Germantown, Md.

The firm has been based at the Maryland Technology Development Center incubator in Rockville since 2006. (That’s the same location as U.S. stem cell firm Neuralstem, Inc.)

What do prospective patients need to know about the procedure?

First, fat is extracted (liposuction) from the patient’s body at the Maryland lab. (Fat has long been known to be a rich source of stem cells.) The cells harvested from the fat samples at the lab are shipped for culturing and expansion in Korea. Patients then travel to Korea, thence to China to be treated using intravenous injections of their own stem cells.

It’s a procedure similar to that used by other companies: harvest and process the stem cells here in the United States – that’s legal – then ship the cells overseas to countries like Mexico, China, etc., where regulation of stem cell treatments is fairly lax, to say the least.

“We have helped a lot of people with rheumatoid arthritis with a one-time IV injection. It’s really amazing to watch,” an RNL spokesman told the Washington Business Journal recently.

So they say.

As noted above, we are trying to get treatment cost information from RNL. And maybe even some scientific proof that the cures they promise actually occurred.

Stay tuned for more updates. But in the meantime, you can view a testimonial video by an arthritis patient who traveled to China for treatment using his own RNL-processed stem cells. In the video, he claims a remarkable improvement in his arthritis symptoms (and symptoms of other medical conditions he was dealing with) after only two weeks. Question: Did the improvements persist? Were they really due to the stem cells? We don’t know.

We’ve asked representatives of RNL Biostar to fill in the blanks for us, but haven’t heard from them yet. We also asked for comment from Geron.

Click here to visit the RNL Biostar Web site, then navigate to the Patients page to see the video.

The firm has been based at the Maryland Technology Development Center incubator in Rockville since 2006.

The company says it is testing stem cell-based treatments for both Buerger’s disease, an inflammatory and blood clotting condition, and osteoarthritis, in Korea, and has been approved by South Korean authorities to begin spinal cord injury treatments at the end of the year using a patient’s own fat-derived stem cells.

Stem cells extracted from patients’ fat samples collected at the Maryland lab are shipped for culturing in Korea. Patients then travel to China and Japan to be treated using intravenous injections of their own stem cells.

“We have helped a lot of people with rheumatoid arthritis with a one-time IV injection. It’s really amazing to watch,” said an RNL spokesman.

By Tierney Plumb, “RNL Biostar opens facility in Germantown incubator”, August 24, 2009, © Washington Business Journal

By Finbarr Bunting, “First Kiwi to try stem cell treatment”, © 2009 Fairfax New Zealand Limited, 7-26-2009