“We take responsibility for all participants in phase 3 clinical trial to the end.”
“We take responsibility for all participants in phase 3 clinical trial to the end.”
  • 글·한정선 기자ㅣ번역·김성혜 인턴기자 (desk@k-health.com)
  • 승인 2020.03.29 10:50
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Nature Cell proceeds phase 3 clinical trial with “JointStem,” a stem cell medication

A groundbreaking type of phase 3 clinical trial for osteoarthritis (degenerative arthritis) patients has been conducted in Korea, drawing attention. It is the phase 3 clinical trial of “JointStem” which is performed by RBio, a related company of Nature Cell.

RBio is conducting a multicenter, randomized, double-blind, and placebo-controlled phase 3 clinical trial for patients with osteoarthritis of the knee to examine the efficacy and safety of JointStem, an adipose tissue-derived mesenchymal stem cells medication.

The reason RBio’s clinical trial is in the center of attention is that it provides free treatment for patients who received a placebo in the control group after all the procedures are carried out. This clinical test is performed with one-on-one randomization and a double-blind method, with half of the participants taking a placebo. If the placebo group wants, then they are given chances for a stem cell treatment at no cost once the trial is over.

"This kind of decision is hard to find in a general clinical trial... It is to express the gratitude for participants and also the willingness to take responsibility as a bio company challenging for the treatment of incurable diseases," an RBio official commented. Nature Cell also plans to apply for approval of related clinical trials to the U.S. FDA.

As the company’s determination is revealed to the public, many patients with osteoarthritis participate or hope to participate in this clinical trial. Recently, Choi (age 68), who was waiting for a final result from a university hospital said, “I’ve been wanting to receive stem cell treatment, but the opportunity never came since the procedure is hard to get in Korea and is expensive. Then I participated without hesitation after hearing about the clinical trial.” Mrs. Moon (age 73), said, “A while ago, my son recommended me to participate and so I applied for it at the university hospital in Seoul. I trust and look forward to the company’s policy of providing stem cell treatment to all participants at no cost.”

This clinical trial is a certified verification procedure to confirm efficacy and safety of reducing symptoms and improving knee joint function by injecting the patients with stage 3 osteoarthritis a dose of JointStem, a stem cell medication extracted from their fat tissues.

In the clinical trial, patients in both the experimental group (JointeStem) and the control group (placebo) will be followed-up for about 30 weeks after clinical trial medication is taken, during which patients need to visit the hospital six to seven times for examination. However, the group injected with JointStem medication will be followed-up for up to five years from the date of the first injection even after the clinical trial is over.

Subjects are confirmed to have stage 3 osteoarthritis of the knee based on the ACR global functional criteria and receive clinical trial medication, x-ray, MRI, blood test, and ECG all for free and a little money for transportation expenses. The institutes carrying out the clinical trial in Seoul are: Severance Hospital, Gangnam Severance Hospital, Kyunghee University Medical Center, Samsung Medical Center, Seoul St. Mary's Hospital, and Chung-Ang University Hospital, and in other regions are: Gyeongsang National University Hospital, Chungbuk National University Hospital, Jeonbuk National University Hospital, Yeungnam University Medical Center, and Keimyung University Dongsan Medical Center. Hence there are 12 hospitals with a total of 260 patients registered. Those who wish to participate should contact RBio Development Division.

"We expect this clinical trial to be an opportunity to overcome degenerative arthritis, which is one of the world's leading incurable diseases," RBio’s CEO, Jeong Chan Ra said. "We wish that more patients with knee osteoarthritis participate in hopes of cure and alleviation of individuals' pain."

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