NCT03007576

Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)

Phase I Clinical Trial - Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: EMO Biomedicine Corporation · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Osteoarthritis,Knee

Interventions

Type	Name	Description
BIOLOGICAL	RegStem	RegStem, 1.5 ml, one injection

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-08-31
• Completion: 2019-08-31
• First posted: 2017-01-02
• Last updated: 2019-11-13

Locations

1 site across 1 country: Taiwan