Effects of α MAT Versus Steroid Injection in Knee Osteoarthritis (STα MAT-knee Study)

• Status: Recruiting
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Knee Osteoarthritis (OA) is a common degenerative knee condition of the knee which is treated symptomatically. Knee cartilage tissue has little regenerative ability With the developments in regenerative medicine, stem cells might also be used in knee OA. Recently, adipose tissue has been identified as means for autologous mesenchymal stem cells (aMAT) using non-enzymatic method. Lipogems® is FDA-approved closed-system and directly producing ready-to-use aMAT. Some observational studies showed its potential in knee chondropathy. With no clinical trial done as yet, the investigators will hereby study the comparative efficacy of corticosteroid (current practice) versus Lipogems® in patients with knee OA. The knee MRI changes, clinical and patient-based outcomes will compared between baseline and throughout till 6 months after treatment. This study aims to show the comparative efficacy of Lipogems® as compared to corticosteroid in knee OA patients and to demonstrate its cartilage regeneration potential, which will ultimately deter surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American University of Beirut Medical Center

Criteria

Inclusion Criteria:

• Patients who are ≥ 45 years old

• Symptomatic knee OA defined as symptoms of knee pain and/or decreased range of motion (ROM)

• Classified radiographically as having Grade 2 or 3 Knee OA

• Failure of 3-months conservative management (NSAIDs and Physical therapy)

Exclusion Criteria:

• Patients < 45 years old

• Pregnant or breastfeeding women

• Cancer patients

• Rheumatoid arthritis patients

• Patients having any autoimmune disease affecting the joint

• Patients who have had hyaluronic acid injection <1 year ago

• Patients who have undergone lower extremity surgery or trauma on the same side

• Hypersensitivity to methylprednisolone (Depo-Medrol®)or any of its components, lidocaine/xylocaine or any of its components, and any of the ingredients of Lipogems® injection kit

• Patients with acute systemic or local infection

• Patients on anticoagulants (warfarin, coumadin, heparin, Xeralto, or Plavix)