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    Location:Home > Products > Safe and Effective
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    • Safe and Effective
    • Comparison with other treatments


    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.?

    Results from the Clinical Trial for Safety and Proof-of-Concept With 7 Years of Extended Follow-Up showed that the application of CARTISTEM appears to be safe and effective for the regeneration of durable articular cartilage in osteoarthritic knees.






    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.



    色五月丁香五月综合五月亚洲
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