- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04230902
Effects of α MAT Versus Steroid Injection in Knee Osteoarthritis (STα MAT-knee Study)
A Prospective Randomized Comparative Clinical Trial Evaluating the Effects of Autologous Microfractured Adipose Tissue (α MAT) Versus Steroid Injection in Knee Osteoarthritis (STα MAT-knee Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Asdghig Der-Boghossian/study coordinator
- Phone Number: 5463 +9611350000
- Email: ad24@aub.edu.lb
Study Locations
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-
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Beirut, Lebanon, 11-0236
- Recruiting
- American University of Beirut Medical Center
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Contact:
- Asdghig Der-Boghossian
- Phone Number: +9611350000
- Email: ad24@aub.edu.lb
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lipogems
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.
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Autologous Microfragmented Adipose Tissue derived using Lipogems® Kit
Other Names:
|
Active Comparator: Steroid
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.
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intra-articular knee injection of corticosteroid
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparing the total pain score pre- and post-injection differences between the two arms
Time Frame: 6 months
|
The difference in total pain scores (using numerical rating scale) between the baseline visit (prior to injection) and 6 months after injection will be obtained for each arm.
And these differences will be compared between Lipogems and Steroid arms using t-test to assess the effect of each injection type on pain severity
|
6 months
|
Comparing MOAKS pre-and post-injection differences between the two arms
Time Frame: 6 months
|
The difference in MOAKS values (MRI Osteoarthritis Knee Score) between the baseline visit (prior to injection) and 6 months after injection will be obtained for each arm.
And these differences will be compared between Lipogems and Steroid arms using t-test to assess the anatomic effects of each injection type.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical outcomes-extension
Time Frame: 6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)
|
The extension lag (in degrees by clinical exam) as assessed by the clinician at baseline (0, pre-injection) and each visit (2 weeks, 6weeks, 3months, and 6months) will be noted and compared between the two arms at each visit timepoint
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6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)
|
Clinical outcomes-flexion
Time Frame: 6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)
|
The flexion range (in degrees by clinical exam) as assessed by the clinician at baseline (0, pre-injection) and each visit (2 weeks, 6weeks, 3months, and 6months) will be noted and compared between the two arms at each visit timepoint
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6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)
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Clinical outcomes-stability
Time Frame: 6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)
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The knee stability (presence/absence) results as assessed by the clinician at baseline (0, pre-injection) and each visit (2 weeks, 6weeks, 3months, and 6months) will be noted and compared between the two arms at each visit timepoint
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6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)
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Cartilage thickness
Time Frame: 6 months (at 0weeks & 6months)
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Comparing the average difference in thickness of the knee cartilage (in mm), measured on MR image, between the two arms between baseline and 6 months.
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6 months (at 0weeks & 6months)
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Patient-based outcomes
Time Frame: 6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)
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The difference scores of patient-based outcome questionnaires (Lipogems® Questionnaire-Knee, and Knee injury and Osteoarthritis Outcome Score or KOOS) between baseline and post-injection follow-ups (2weeks, 6 weeks, 3months, 6 months) will be measured.
These difference in scores will be compared between the two arms.
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6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)
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Pain score-other follow-ups
Time Frame: 3 months (at 0weeks, 2weeks, 6weeks, 3months)
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The difference in pain scores (numerical rating scale) between the baseline visit (prior to injection) and at each follow-up visit (2 weeks, 6 weeks, 3months) will be obtained for each arm.
And these differences will be compared between the two arms.
|
3 months (at 0weeks, 2weeks, 6weeks, 3months)
|
Collaborators and Investigators
Investigators
- Study Director: Said Saghieh, MD, American University of Beirut Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIO-2017-0440
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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