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

American University of Beirut Medical Center

Status and phase: Unknown; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Drug: Corticosteroid injection; Biological: Microfragmented Adipose Tissue Transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT04230902

BIO-2017-0440

Details and patient eligibility

About

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.

Full description

Knee Osteoarthritis (OA) is a common degenerative condition of the knee. Its current management is symptomatic. These patients might eventually need total knee arthroplasty (TKA). With the developments in regenerative medicine, stem cell has been suggested as means to regenerate the knee cartilage tissue which otherwise has little regenerative ability. Initially, stem cells were obtained from bone marrow cells; however, now they can also be obtained from adipose tissue through liposuction. With developments of less invasive liposuction techniques, adipose tissue has been identified as means for autologous mesenchymal stem cells (aMAT). There are two ways of obtaining aMAT form adipose tissue: enzymatic, which has controversies related to Good Manufacturing Practice and low yield, and non-enzymatic method which was recently further developed to a closed-system and directly ready-to-use aMAT producing Lipogems®. Lipogems® is FDA-approved for several applications including orthopedic use. A couple of case reports and cohort studies showed its potential use in knee chondropathy. Until now, no clinical trials compared its effect to the knee OA standard of care which is the intra-articular corticosteroid injection. Here, the investigators will study the comparative efficacy of corticosteroid versus Lipogems® in patients with knee OA.

This randomized clinical trial will include 48 patients with symptomatic knee OA ≥ 45 years old with no contraindication of corticosteroid and/or Lipogems® use. These patients will be divided equally into two groups: group S who will receive intra-articular corticosteroid knee injection and group L whose aMAT will be harvested using Lipogems® and be injected intra-articularly. The knee pain, clinical parameters, and patient-related outcome measures (knee injury and osteoarthritis outcome score and Lipogems® Questionnaire-knee) will be assessed at baseline, 2-week, 6-week, 3-month, and 6-month. Also, knee MRI will be done at baseline and 6-months to visualize any changes (MRI Osteoarthritis knee score). These outcomes will be evaluated over the 6-month period and the difference between baseline and follow-up will be compared between the two groups.

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Lipogems

Experimental group

Description:

The cases assigned to this group will be injected intra-articularly with Lipogems®. The patients will undergo harvesting of their own adipose tissue for aMAT then this aMAT will be injected intra-articularly in the knee. It will be administered once at the baseline visit of the study.

Treatment:

Biological: Microfragmented Adipose Tissue Transplant

Steroid

Active Comparator group

Description:

The cases assigned to this group will be injected intra-articularly in the knee with corticosteroids. No extra preparation of any type is necessary in this case. It will be administered once at the baseline visit of the study.

Treatment:

Drug: Corticosteroid injection