Degenerative arthritis is a disease caused by bones or tendons at joints damaged by gradual or degenerative transformation of cartilage that protects joints. Its symptoms include swelling and pain. The most common initial symptom is local pain around the joints where the arthritis occurred. It is different from rheumatoid arthritis in that it does not cause symptoms that affect the entire body. At first, pain gets worse when moving the affected joint. However, the pain may persist regardless of movement once it progresses further. Other symptoms include decreased scope of joint movement, edema, tenderness around joints. Fricative sound may be felt once the joint surfaces become uneven due to loss and transformation of cartilage.
Cartilage is a very unique tissue without any vessel or nerve. Once damaged, it cannot be fully restored. Despite extensive researches in the area, medications so far only alleviate the symptoms, by controlling pain and improving bodily functions and the patients’ quality of living. No treatment has been developed that effectively treats cartilage loss. Degenerative arthritis is commonly treated with correction of living habits, pain killers, coupled with joint injection of non-steriopid antiflammatory medicine or steroid/hyaluronic acid lubricant. When the pain becomes worse, joint packing (hip/shoulder joint) or joint replacement (hip/knee joint) must be performed to improve the patient’s living quality. There are a variety of treatments currently used, but none of them offer fundamental treatment through joint renewal.
The name JointStem is a combination of Joint and Stem, the latter referring to stem cell. It is an autologous stem cell-based medicine, injected into the glenoid cavity of degenerative arthritis patients to renew their cartilage, alleviate pain, and improve joint functions.
These effects are based on the mechanism of JointStem, which directly renews damaged cartilage, or helps cartilage renewal through various nutrients secreted from JointStem.
1. Phase 1/2, clinical trial in Korea
In accordance with the Phase 1/2 Clinical trial Plan approved by Ministry of Food and Drug Safety, the clinical trial was conducted in Boramae Hospital in Seoul for knee degenerative arthritis patients. With increasing the dose, its drug fastness and safety of JointStem was confirmed and the optimal dose was determined. A total of 12 patients were treated with 100 million stem cells. As a result, we found statistically significant improvement in knee funcion, pain and quality of life assessment(WOMAC, KSCRS, VAS, etc.). Above all, cartilage regeneration was found on all 12 patients through MRI and arthroscopy.
The results of the study were published in the most prominent journal in the field of stem cells, ‘STEM CELLS’.
(Link : http://onlinelibrary.wiley.com/doi/10.1002/stem.1634/full)
2. Phase 2b/3, clinical trial in Korea
In accordance with the Phase 2b/3 Clinical trial Plan approved by Ministry of Food and Drug Safety, phase 2b study was conducted in Kyung Hee University Hispital at Gangdong and Gangnam Severance Hospital in Seoul for knee degenerative arthritis patients.
A total of 24 patients were included in the treatment group(12 patients) and control group(12 patients). The patients of the treatment group were treated with JointStem containing 100 million autologous adipose derived mesenchymal stem cells and were evaluated for efficacy and safety for 6 months. As a result, we found that the knee function, pain, and quality of life were significantly improved in comparison with the control group.
1. Phase 2 Clinical trial In USA(single administration)
Phase 2, Clinical trial is in progress in accordance with the Phase 2 clinical trial protocol approved by Food and Drug Administration (FDA). 28 patients were enrolled, and the patients of the treatment group were treated with JointStem containing 100 million autologous adipose derived mesenchymal stem cells and the patients of the control group were treated with hyaluronic acid. We are currently evaluating efficacy and safety.
2.Phase 2 Clinical trial In USA(repeated administration)
In order to compare the efficacy and safety of single administraion and repeated administration for patients with degenerative arthritis, the clinical trial is under preparation and will be started in the first half of 2017.
JointStem was approved for regenerative medical treatment for degenerative arthritis from Japan Health and Welfare Ministry in 2015, and is currently being treated at a local hospital in Japan.
In order to confirm the in vivo distribution and tumorigenicity of JointStem, it was commissioned to the Korea Institute of Toxicology (KIT). As a result, no adverse events or tumors associated with JointStem administration were observed.
Also, We confirmed the therapeutic efficacy of osteoarthritis in the rabbit osteoarthritis model by Chungbuk National University. As a result, we found the adherence of stem cells to the injured cartilage surface layer and the defects through the cell adhesion confirmation test using fluorescence. In addition, we found that the combination of TSP-2 and stem cells increased cartilage regeneration efficacy.