Knee OsteoarthritisPhase 4NCT04675359
Adipose-derived MSCs After Enzymatic Digestion vs. Mechanically Fragmented Fat Transfer in Knee Osteoarthritis Treatment
A Phase 4 study testing Autologous adipose derived Mesenchymal Stromal Cells (MSC) injection into the knee joint in people with Knee Osteoarthritis and Chondropathy, run by Medical University of Warsaw.
Trial summary
The aim of the study is to compare the clinical effects of treatment of knee osteoarthritis using adipose tissue mesenchymal stromal cells obtained by an enzymatic method with the outcomes of the therapy with the mechanically fragmented adipose tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Chondropathy
- What is being tested?
- Autologous adipose derived Mesenchymal Stromal Cells (MSC) injection into the knee joint
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Dec 2023
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with symptomatic gonarthrosis diagnosed based on the X-ray, MRI and clinical examination, previously unsuccessfully treated (rehabilitation, NSAIDs, hyaluronic acid, platelet-rich plasma)
- Primary knee osteoarthritis
- Willingness and consent to participate in the study
- Readiness to attend control visits
Who cannot join
- Failure to meet the inclusion criteria
- Active chronic infection
- Metal implant made of a ferromagnetic material that will exclude the patient from magnetic resonance imaging
- Use of anticoagulants
- General and intra-articular use of steroids during the last year
- Pregnancy, breastfeeding
Show all 9Show fewer
- Any autoimmune and rheumatic disease, or conditions that influence the accuracy of test results
- Taking drugs or cytostatic medications in the last 30 days
- Mental disorders, alcohol and drug addiction
Trial locations and contacts
No sites are listed yet.
Artur Stolarczyk, MD, PhD contact
About this study
Official title: Comparison of the Treatment Results of Knee Osteoarthritis Using Adipose Tissue Mesenchymal Stromal Cells Derived Through Enzymatic Digestion and Mechanically Fragmented Adipose Tissue
The aim of the study is to compare the clinical effects of treatment of knee osteoarthritis using adipose tissue mesenchymal stromal cells obtained by an enzymatic method with the outcomes of the therapy with the mechanically fragmented adipose tissue. Identification and functional analysis of the regenerative capacity of MSCs derived from the adipose tissue depending on three variables (body weight, sex and age) will help to develop a targeted therapy for different groups of patients and will determine the effectiveness of both methods of treatment. An attempt was made to identify the groups of patients with the greatest regeneration potential of the adipose tissue, and thus indicate those with the most probable improvement of the joint condition.
Read the detailed description
Based on the calculation of the sample size using power analysis of the test, investigators plan to include 100 adults with primary knee osteoarthritis in this study. The patients will undergo lipoaspiration under sterile conditions of the operating theatre, the collected lipoaspirates will be further processed - enzymatically with the use of collagenase or mechanically using the Lipogems system. After collection, lipoaspirates will be immediately transferred to the laboratory of the Department of Regenerative Medicine with a tissue and cells bank in Warsaw, and the preparations will be administered to the patients' knee joints in the operating room under ultrasound control.
The Lipogems system is defined as a minimal tissue manipulation system. In contrast, the administration of preparations produced using an enzymatic method requires advanced actions.
Lipoaspiration will be performed using blind cannulas and vacuum syringes introduced through the abdominal wall with a three-millimetre incision on the skin after previous injection to the adipose tissue with modified Klein's solution (500 ml of saline solution, 1 ml of adrenaline, 40 ml of 2% lignocaine), which makes the collection easier. 10 ml of the collected adipose tissue will be used to examine the samples after previous gradient drainage from Klein's solution. Immediately after collection, the samples will be sent to the laboratory for analysis (cell count testing, culture, phenotype identification, analysis by flow cytometry).
The patients will be monitored in the hospital outpatient clinic for one year after the procedure; the control visits will take place: after 2 and 6 weeks, then after 3 and 6 months and after a year. A physical examination and the assessment using the KOOS questionnaire will be performed. Before the procedure and after one year, an X-ray and MRI with T-2 Mapping will be carried out in order to evaluate the condition of the cartilage.
- Conditions
- Knee Osteoarthritis, Chondropathy
- Being tested
- Autologous adipose derived Mesenchymal Stromal Cells (MSC) injection into the knee joint
- Keywords
- MSC, SVF, adipose tissue, knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Cartilage Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous adipose derived Mesenchymal Stromal Cells (MSC) injection into the knee jointProcedure or surgery
Also called Autologous mechanically fragmented adipose tissue injection into the knee joint using Lipogems device
Injections of the two adipose tissue derived products containing MSCs into the knee joints with osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| Enzymatic digestion group | Active comparator | A group treated with a stromal vascular fraction (SVF) with mesenchymal stromal cells (MSC) injection in the knee joint after an enzymatic digestion of autologous adipose tissue Receives: Procedure: Autologous adipose derived Mesenchymal Stromal Cells (MSC) injection into the knee joint |
| Mechanical fragmentation group | Active comparator | A group treated with a mechanically fragmented (using Lipogems device) autologous adipose tissue injection in the knee joint Receives: Procedure: Autologous adipose derived Mesenchymal Stromal Cells (MSC) injection into the knee joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in patients reported outcome measures - Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Measured: 1,3,6 and 12 months after procedure
Changes in flexibility of the knee joint
Range of motion assessment by goniometer measurements
Measured: 1,3,6, and 12 months after procedure
Secondary outcomes (2)
Changes in X-ray imaging of the knee joint in a standing position (AP view)
Articular cartilage volume evaluation by joint gap measurements
Measured: 6 months and 1 year after procedure
Changes in MRI with T-2 Mapping of the knee cartilage
Articular cartilage quality evaluation in T-2 Mapping
Measured: 6 months and 1 year after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Jul 2021 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Artur Stolarczyk, MD, PhD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675359
- Sponsor's protocol ID
- MSC
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krzesniak AM, Radzimowski K, Stolarczyk A. Comparison of the treatment results of knee osteoarthritis using adipose tissue mesenchymal stromal cells derived through enzymatic digestion and mechanically fragmented adipose tissue. Medicine (Baltimore). 2021 Mar 5;100(9):e24777. doi: 10.1097/MD.0000000000024777.
PubMed 33655941
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Treatment Results of Knee Osteoarthritis Using Adipose Tissue Mesenchymal Stromal Cells Derived Through Enzymatic Digestion and Mechanically Fragmented Adipose Tissue
- ClinicalTrials.gov ID
- NCT04675359
- Acronym / sponsor ID
- MSC
- Conditions
- Knee Osteoarthritis, Chondropathy
- Keywords
- MSC, SVF, adipose tissue, knee osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 19 Dec 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.
The aim of the study is to compare the clinical effects of treatment of knee osteoarthritis using adipose tissue mesenchymal stromal cells obtained by an enzymatic method with the outcomes of the therapy with the mechanically fragmented adipose tissue. Identification and functional analysis of the regenerative capacity of MSCs derived from the adipose tissue depending on three variables (body weight, sex and age) will help to develop a targeted therapy for different groups of patients and will determine the effectiveness of both methods of treatment. An attempt was made to identify the groups of patients with the greatest regeneration potential of the adipose tissue, and thus indicate those with the most probable improvement of the joint condition.
Detailed description
Based on the calculation of the sample size using power analysis of the test, investigators plan to include 100 adults with primary knee osteoarthritis in this study. The patients will undergo lipoaspiration under sterile conditions of the operating theatre, the collected lipoaspirates will be further processed - enzymatically with the use of collagenase or mechanically using the Lipogems system. After collection, lipoaspirates will be immediately transferred to the laboratory of the Department of Regenerative Medicine with a tissue and cells bank in Warsaw, and the preparations will be administered to the patients' knee joints in the operating room under ultrasound control.
The Lipogems system is defined as a minimal tissue manipulation system. In contrast, the administration of preparations produced using an enzymatic method requires advanced actions.
Lipoaspiration will be performed using blind cannulas and vacuum syringes introduced through the abdominal wall with a three-millimetre incision on the skin after previous injection to the adipose tissue with modified Klein's solution (500 ml of saline solution, 1 ml of adrenaline, 40 ml of 2% lignocaine), which makes the collection easier. 10 ml of the collected adipose tissue will be used to examine the samples after previous gradient drainage from Klein's solution. Immediately after collection, the samples will be sent to the laboratory for analysis (cell count testing, culture, phenotype identification, analysis by flow cytometry).
The patients will be monitored in the hospital outpatient clinic for one year after the procedure; the control visits will take place: after 2 and 6 weeks, then after 3 and 6 months and after a year. A physical examination and the assessment using the KOOS questionnaire will be performed. Before the procedure and after one year, an X-ray and MRI with T-2 Mapping will be carried out in order to evaluate the condition of the cartilage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enzymatic digestion group | Active comparator | Procedure: Autologous adipose derived Mesenchymal Stromal Cells (MSC) injection into the knee jointA group treated with a stromal vascular fraction (SVF) with mesenchymal stromal cells (MSC) injection in the knee joint after an enzymatic digestion of autologous adipose tissue |
| Mechanical fragmentation group | Active comparator | Procedure: Autologous adipose derived Mesenchymal Stromal Cells (MSC) injection into the knee jointA group treated with a mechanically fragmented (using Lipogems device) autologous adipose tissue injection in the knee joint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults with symptomatic gonarthrosis diagnosed based on the X-ray, MRI and clinical examination, previously unsuccessfully treated (rehabilitation, NSAIDs, hyaluronic acid, platelet-rich plasma)
- Primary knee osteoarthritis
- Willingness and consent to participate in the study
- Readiness to attend control visits
Key exclusion criteria (9 listed)
- Failure to meet the inclusion criteria
- Active chronic infection
- Metal implant made of a ferromagnetic material that will exclude the patient from magnetic resonance imaging
- Use of anticoagulants
- General and intra-articular use of steroids during the last year
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 |
|---|---|---|
| Autologous adipose derived Mesenchymal Stromal Cells (MSC) injection into the knee jointAlso: Autologous mechanically fragmented adipose tissue injection into the knee joint using Lipogems deviceInjections of the two adipose tissue derived products containing MSCs into the knee joints with osteoarthritis | Procedure or surgery | Enzymatic digestion group, Mechanical fragmentation group |
Primary outcome
Changes in patients reported outcome measures - Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 1,3,6 and 12 months after procedure
The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Changes in flexibility of the knee joint
Time frame: 1,3,6, and 12 months after procedure
Range of motion assessment by goniometer measurements
2 secondary outcomes
Changes in X-ray imaging of the knee joint in a standing position (AP view)
Time frame: 6 months and 1 year after procedure
Changes in MRI with T-2 Mapping of the knee cartilage
Time frame: 6 months and 1 year after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Derived from this study: PubMed 33655941Krzesniak AM, Radzimowski K, Stolarczyk A. Comparison of the treatment results of knee osteoarthritis using adipose tissue mesenchymal stromal cells derived through enzymatic digestion and mechanically fragmented adipose tissue. Medicine (Baltimore). 2021 Mar 5;100(9):e24777. doi: 10.1097/MD.0000000000024777.
- 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.
Artur Stolarczyk, MD, PhD contact
Artur Stolarczyk, MD, PhD principal investigator
Medical University of Warsaw
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Autologous adipose derived Mesenchymal Stromal Cells (MSC) injection into the knee joint in people with Knee Osteoarthritis and Chondropathy, run by Medical University of Warsaw.
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 9 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 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Anna Krześniak, MD (+48600104793, anna.krzesniak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in patients reported outcome measures - Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: 1,3,6 and 12 months after procedure). 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?
On the ClinicalTrials.gov record for NCT04675359, which also lists 1 linked publication.
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 8 Jan 2021.