Osteoarthritis Clinical Trial
Official title:
Randomized, Open-Label, Multi-Center and Phase 3 Clinical Trial to Compare the Efficacy and Safety of Cartistem® and Microfracture in Patients With Knee Articular Cartilage Injury or Defect
The purpose of the study is to assess and compare the safety and efficacy of the allogeneic-unrelated umbilical cord blood-derived mesenchymal stem cell product (Cartistem®) to that of a microfracture treatment in patients with articular cartilage defect or injury.
The cartilage is a unique avascular, aneural tissue that does not regenerate easily once
damaged. Chondral defects or damages to articular cartilages due to accidents, necrosis of
subchondral bone tissue, or arthritis have become some of the more common disorders today.
About 15% of the world's population is reportedly suffering from cartilage and joint damages
such as degenerative arthritis and rheumatoid arthritis. As population aging progresses and
as more young people start taking up active sports, the size of the target patient group is
also growing. However, despite ongoing research, an effective treatment for cartilage
defects is yet to be discovered. Various different types of treatments are currently in use,
such as drug therapy, arthroscopy, and artificial joint surgery. However, they all fail to
address the root cause. Complete treatment, or regeneration of damaged or defective
cartilage is impossible and continuous drug administration or secondary surgeries are
required in many cases.
As a way of regenerating the damaged or defective cartilage tissue, treatment of localized
damage to articular cartilage using autologous chondrocytes is currently under review. A few
life science companies both home and abroad are marketing this method of treatment called
'autologous chondrocyte transplant'. The treatment involves the extraction of healthy
cartilage tissue from the patient which is then cultured and transplanted into the damaged
site.
However, this treatment requires the extraction of chondrocytes directly from the patient
and thus causes trauma in healthy articular cartilage. Also, this type of treatment cannot
be applied to large lesions, nor is the efficacy satisfactory in patients over the age of 40
whose cellular activation levels are low. Thus, autologous chondrocyte transplant is rather
limited in the number of cells harvested and their activation level and is therefore
restricted in terms of treatment site, severity of the condition, and the size of lesion.
The current technology allows the application of treatments in local cartilage defects but
not in degenerative arthritis or rheumatoid arthritis. The technology needs to be taken up
to another level in order to benefit such prevalent arthritic disorders. Treatments using
stem cells do not cause damage to healthy articular cartilage as they don't require the
harvesting of healthy cartilage tissues from the patients. Moreover, the number of
successfully cultured cells is larger due to the excellent proliferation capability of stem
cells and thus, mass supply is possible.
This clinical trial for the stem cell therapies is essential because treatment of cartilage
defects with umbilical cord blood-derived mesenchymal stem cells, known to have the highest
level of activity among all adult stem cells, opens the possibility of articular cartilage
regeneration even for aged patients and patients with large lesions unable to benefit from
existing treatments.
The biggest challenge faced by nations competing in the field of "tissue differentiation and
regeneration using stem cells" is the question of whether or not the use of embryonic stem
cells is ethical. Chondrogenesis using umbilical cord blood-derived mesenchymal stem cells
can not only avoid similar challenges, but also present an innovative treatment mode with
significant clinical implications for the patients.
In the clinical study, mesenchymal stem cells will be isolated from umbilical cord blood and
cultured, mixed with semi- solid polymer, and administered into the cartilage tissue lesion
by orthopedic surgery in order to stimulate the regeneration of defective cartilage tissue
and to improve their functions.
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