NCT01809769

Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis

Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis by Intra-articular Injection: A PhaseⅠ/Ⅱa, Randomized and Double-blinded Clinical Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Shanghai AbelZeta Ltd. · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Two injections in total and 3 ml autologous adipose-tissue-derived stem cells(haMSCs) for each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following initial injection.

Detailed description

Adipose (fat) tissue is removed by lipo-aspiration (this may take up to 40 minutes). The fat is processed on-site to isolate and obtain the MSCs,then proliferate them. The suspension of the cells is injected into the knee joint under ultrasound guidance. (about 20 minutes).

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Mesenchymal stem cells low-dose group	Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
BIOLOGICAL	Mesenchymal stem cells mid-dose group	Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
BIOLOGICAL	Mesenchymal stem cells high-dose group	Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-03-01
• Completion: 2015-07-01
• First posted: 2013-03-13
• Last updated: 2016-04-04

Locations

1 site across 1 country: China