An Early Phase 1 interventional study of Low Dose of Mesenchymal stem cell and High Dose of Mesenchymal stem cell in Knee Osteoarthritis, sponsored by CAR-T (Shanghai) Biotechnology Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-10-17.
Sponsored by CAR-T (Shanghai) Biotechnology Co., Ltd. · Early Phase 1, Interventional, and Treatment
To evaluate the clinical efficacy and safety of dental pulp mesenchymal stem cells in the treatment of primary mild to moderate knee osteoarthritis through a comparative study with sodium hyaluronate.
20 participants will receive low dose of dental pulp mesenchymal stem cells, 20 participants will receive high dose and another 20 participants will receive sodium hyaluronate
60 participants will receive to evaluate the clinical efficacy and safety of dental pulp mesenchymal stem cells in the treatment of primary mild to moderate knee osteoarthritis through a comparative study with sodium hyaluronate and verify the basis of dental pulp mesenchymal stem cells in the treatment of primary knee osteoarthritis, and to explore a more effective and safe clinical treatment of knee osteoarthritis.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →CAR-T (Shanghai) Biotechnology Co., Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
(1) Those with other diseases that may affect the knee joint, such as rheumatoid arthritis, ankylosing spondylitis, rheumatoid arthritis, gout and other rheumatic diseases, bone tumors, osteoporosis, bone tuberculosis or obvious history of acute trauma, resulting in meniscus injury, ligament rupture and vascular nerve injury; those with previous history of femur, tibial plateau, tibia and fibula fracture. The patients with gonarthritis, the patients with knee joint and surrounding skin infection were not cured.
Patients receiving intraarticular injection of low dose of mesenchymal stem cells.
Biological: Low Dose of Mesenchymal stem cell
Patients receiving intraarticular injection of high dose of mesenchymal stem cells.
Biological: High Dose of Mesenchymal stem cell
Patients receiving intraarticular injection of Sodium Hyaluronate
Drug: Sodium Hyaluronate
Mesenchymal stem cell injection
Also known as: 1
Mesenchymal stem cell injection
Also known as: 2
Sodium Hyaluronate injection
Also known as: 3
Kellgren and Lawrence's rating
X-ray imaging was used to evaluate the degree of improvement in knee joint structure
Time frame: 12 month
WOMAC score
WOMAC score decreased
Time frame: 12 month
Volume of femoral surface of knee joint on MRI
Changes of volume of lateral femoral condylar, medial femoral condylar, lateral tibial condylar, medial tibial condylar and posterior patellar articular surfaces on MRI
Time frame: 12 month
relaxation time of femoral surface of knee joint on MRI
Changes of relaxation time (T1 condylar, T2 condylar, T2\*) of lateral femoral condylar, medial femoral condylar, lateral tibial condylar, medial tibial condylar and posterior patellar articular surfaces on MRI
Time frame: 12 month
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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CAR-T (Shanghai) Biotechnology Co., Ltd.