Knee OsteoarthritisPhase 3NCT04230902
Effects of α MAT Versus Steroid Injection in Knee Osteoarthritis (STα MAT-knee Study)
A Phase 3 study testing Microfragmented Adipose Tissue Transplant and Corticosteroid injection in people with Knee Osteoarthritis, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Microfragmented Adipose Tissue Transplant and Corticosteroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteLebanon
- Study dates
- 4 Mar 2019to 31 Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut Medical Center
Beirut, 11-0236
Asdghig Der-Boghossian, +9611350000, ad24@aub.edu.lb
About this study
Official title: 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)
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Microfragmented Adipose Tissue Transplant, Corticosteroid injection
- Keywords
- mesenchymal stem cell, corticosteroid, adipose stem cell, MRI, pain, Knee
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfragmented Adipose Tissue TransplantBiological
Also called aMAT
Autologous Microfragmented Adipose Tissue derived using Lipogems® Kit
Corticosteroid injectionDrug
Also called steroid
intra-articular knee injection of corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| Lipogems | Experimental | 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. Receives: Biological: Microfragmented Adipose Tissue Transplant |
| Steroid | Active comparator | 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. Receives: Drug: Corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the total pain score pre- and post-injection differences between the two arms
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
Measured: 6 months
Comparing MOAKS pre-and post-injection differences between the two arms
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.
Measured: 6 months
Secondary outcomes (6)
Clinical outcomes-extension
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
Measured: 6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)
Clinical outcomes-flexion
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
Measured: 6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)
Clinical outcomes-stability
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
Measured: 6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)
Cartilage thickness
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.
Measured: 6 months (at 0weeks & 6months)
Patient-based outcomes
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.
Measured: 6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)
Pain score-other follow-ups
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.
Measured: 3 months (at 0weeks, 2weeks, 6weeks, 3months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start4 Mar 2019
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Hasan Baydoun, American University of Beirut Medical Center
- Investigators
- Said Saghieh, MD, Study director, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230902
- Sponsor's protocol ID
- BIO-2017-0440
- Status last verified
- Jan 2020
- First submitted
- 29 Jan 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04230902
- Acronym / sponsor ID
- BIO-2017-0440
- Conditions
- Knee Osteoarthritis
- Keywords
- mesenchymal stem cell, corticosteroid, adipose stem cell, MRI, pain, Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipogems | Experimental | Biological: Microfragmented Adipose Tissue TransplantThe 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. |
| Steroid | Active comparator | Drug: Corticosteroid injectionThe 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- Patients < 45 years old
- Pregnant or breastfeeding women
- Cancer patients
- Rheumatoid arthritis patients
- Patients having any autoimmune disease affecting the joint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microfragmented Adipose Tissue TransplantAlso: aMATAutologous Microfragmented Adipose Tissue derived using Lipogems® Kit | Biological | Lipogems |
| Corticosteroid injectionAlso: steroidintra-articular knee injection of corticosteroid | Drug | Steroid |
Primary outcome
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
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 secondary outcomes
Clinical outcomes-extension
Time frame: 6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)
Clinical outcomes-flexion
Time frame: 6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)
Clinical outcomes-stability
Time frame: 6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)
Cartilage thickness
Time frame: 6 months (at 0weeks & 6months)
Patient-based outcomes
Time frame: 6 months (at 0weeks, 2weeks, 6weeks, 3months, and 6months)
Pain score-other follow-ups
Time frame: 3 months (at 0weeks, 2weeks, 6weeks, 3months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Said Saghieh, MD study director
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Microfragmented Adipose Tissue Transplant and Corticosteroid injection in people with Knee Osteoarthritis, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asdghig Der-Boghossian/study coordinator (+9611350000 ext. 5463, ad24@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the total pain score pre- and post-injection differences between the two arms (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.