Osteoarthritis (OA) is a common and incurable disease for the elderly in Taiwan, so it is an important mission to develop a new treatment for OA. Recently, cellular therapy is a new and popular medical treatment around the world, one of them is "Mesenchymal Stromal Cells (MSCs)". MSCs are found in many tissues of human body and play an important role for repairing, regeneration, anti-inflammatory and chondrogenesis. So, MSC product, RegStem, for osteoarthritis treatment becomes a developing target for new generation drugs. This study is to isolate and expand MSCs(RegStem) from infrapatellar fat pad of subject. When the number of MSCs expands to 1×10\^8, cell will be cryopreserved in the liquid nitrogen tank until all release tests passed. On the distribution day, cell will be thawed and injected into joint cavity of patient (5×10\^7). Subjects will be monitored after MSC product infusion of seven days, one month, six months and one year. The monitoring items include the changes of knee (by appearance, X-ray and MRI of knee) and pain improvement (by questionnaire).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
RegStem, 1.5 ml, one injection
Far Eastern Memorial Hospital
Taipei, Taiwan
Safety of RegStem by incidence of adverse events and changes in physical examinations, vital signs and the results of clinical lab tests.
Time frame: 48 weeks
Clinical assessment of International Knee Documentation Committee (IKDC) score
Assess symptoms of knee, sport activity and function of knee
Time frame: 48 weeks
Clinical assessment of Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 48 weeks
Clinical assessment of visual analogue scale (VAS)
Time frame: 48 weeks
Clinical assessment of knee X-ray
Time frame: 48 weeks
Clinical assessment of knee MRI
Time frame: 48 weeks
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