CARTISTEM is approved for sales in 2012 by Ministry of food and drug safety (MFDS) in Korea for treatment of OA based on the regulatory guideline for stem cell drug where extensive non-clinical and clinical data should be submitted to prove safety and efficacy of the product. The approved indication is a treatment of knee cartilage injury due to repeated trauma or degenerative OA.
1）Treatment with Chinese and western medicine/Acupuncture/Message
They are the traditional treatment
methods, generally adopt the
local injection of sodium hyaluronate and other lubricating substances;Oral
and external drugs: (pain relievers, anti-inflammatory drugs (NASIDs)
Advantage:
The effect of analgesia is relatively fast, suitable for the onset and acute
stage.
Disadvantage:
Can alleviate pain, cannot cure.
2) Microfracture
Microfracture is an arthrosopic
operation that involves drilling small holes in the subchondral bone.The
operation induces bleeding of stem cells from bone marrow into the defect area,
which then leads to regeneration of these stem cells into cartilage and bone of
treated area.
The operation takes about 30 min~1 hour and requires hospitalization for about
2~3 days.
Disadvantage
* Upon microfracture, the number of stem cells leaked from the bone marrow is not enough for complete regeneration and the generated cartilage is known to be fibrous cartilage. Because of such incomplete regeneration, it has been reported that the effect of microfracture is limited as the fibrous cartilage cannot endure the external impact for a long period of time.
* The effect of microfracture has been reported to be poor for the patients with large lesion and the patients older than 50 years. Also, the treatment could cause the formation of subchondral cyst in some cases due to the fracture of the subchondral bone.
3) Total Knee Arthroplasty
Total Knee Arthroplasty is an
operation method for severely damaged osteoarthritis patients. The treatment
can alleviate the pain and improve a range of motion by replacing with the
artificial joint, providing an effective operation with insured results.
There is a total knee replacement
for the entire joint and partial replacement that only replaces the damaged
area. The total operation takes about 2 hours, requiring 3~4 weeks of
hospitalization.
While the effective period varies
depending on the product, TKR is typically effective for about 15 years, and
requires frequent post-operational visits to the hospital for examinations of
infections. Total knee replacement may cause pain as the operation involves an
opening of the joint and the excision of the bones, but the pain reduces after
about 2~3 months.
4) Autologous bone marrow stem cell treatment
Treatment Purpose
· It shall be used for the purpose of tissue regeneration.
Indications
· * Patients with
cartilage defect
① Patients between 15 and 50 years old
② Cartilage defect due to traumatic injury, etc. (ICRS Grade 3-4)
③ Maximum size of cartilage defect: 2~10cm2
Procedure
Harvested autologous bone marrow undergoes the centrifugal separation, and bone marrow stem cells are isolated. The harvested stem cells are transplanted arthroscopically in the defect area. Operation takes about 1 hour and 30 min with 1~2 weeks of hospitalization.