Osteoarthritis,Knee Clinical Trial
Official title:
Phase I Clinical Trial - Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)
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).
n/a
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