Bilateral Knee OsteoarthritisNCT04567732
Bilateral Knee Osteoarthritis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo
A study testing injection of Filtered Autologous Adipose Tissue in people with Bilateral Knee Osteoarthritis and Autologous Adipose Tissue, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The purpose of the study is to assess the radiological and clinical outcomes comparing two different treatments (Filtered Autologous Adipose Tissue versus Placebo) in patients affecting bilateral knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bilateral Knee Osteoarthritis, Autologous Adipose Tissue
- What is being tested?
- injection of Filtered Autologous Adipose Tissue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 22 Feb 2021to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bilateral degenerative chondropathy of the knees showing at least a grade 2-3 kellgren-lawrence classification (absence of severe osteoarthritis)
- An overall Pain subscale score of the Western Ontario and McMaster Universities Osteoarthritis Index between a value of 9 and 19.
- Failure, intended as the persistence of symptomatology, after at least one conservative treatment cycle (pharmacological, physiotherapeutic or infiltrative treatment);
- Ability and informed consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up;
Who cannot join
- Patients incapable of understanding and wanting;
- Diagnosis of leukaemia, known presence of metastatic malignant cells, ongoing or planned chemotherapy;
- Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis resulting from another inflammatory disease; infection with human immunodeficiency virus (HIV), viral hepatitis; chondrocalcinosis;
- Patients with uncontrolled diabetes mellitus;
- Patients with uncontrolled thyroid metabolic disorders;
- Patients who abuse alcoholic beverages, drugs or medicines;
Show all 12Show fewer
- Patients with misalignment of the lower limbs above 10 degrees;
- Body Mass Index > 40;
- Pregnant or lactating state or intention to become pregnant during the period of participation in the study.
- Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening.
- Patients who have had knee surgery in the 12 months prior to screening.
- Patients with insufficient abdominal adipose tissue, assessed by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double Blind Clinical Study on the Treatment of Bilateral Knee Arthrosis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo
The purpose of the study is to assess the radiological and clinical outcomes comparing two different treatments (Filtered Autologous Adipose Tissue versus Placebo) in patients affecting bilateral knee osteoarthritis.
After be randomized, every patient will be treated in both legs, one leg with Adipose Tissue and the other one with Placebo.
Read the detailed description
All patients who meet the inclusion criteria and giving written informed consent will be randomized.
Every patient will be treated with a single injection of Filtered Autologous Adipose Tissue in one knee and single injection of Placebo in the other, based on the randomization.
After the treatment patients will be followed up to 24 months.
- Being tested
- injection of Filtered Autologous Adipose Tissue, Placebo
- Keywords
- Arthrosis, Osteoarthrosis, Degenerative joint disease, Knee degenerative joint disease., Bilateral, Fat tissue
- Medical subject headings
- Osteoarthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of Filtered Autologous Adipose TissueCombination product
Single injection of Filtered Autologous Adipose Tissue
PlaceboDrug
Single injection of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Filtered Autologous Adipose Tissue | Experimental | based on randomization one of the two knees will be treated with a single injection of Filtered Autologous Adipose Tissue Receives: Combination Product: injection of Filtered Autologous Adipose Tissue |
| Placebo | Placebo comparator | based on randomization one of the two knees will be treated with a single injection of Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
It is a 0 - 100 standardized questionnaire widely used for the evaluation of patients with knee osteoarthrosis. The questionnaire is made by three subscale: Pain (5 questions ranging from 0 - 20), Stiffness (2 questions ranging from 0 - 8) and Function (17 questions ranging from 0 - 68).
Measured: 12 months
Secondary outcomes (11)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
It is a 0 - 100 standardized questionnaire widely used for the evaluation of patients with knee osteoarthrosis. The questionnaire is made by three subscale: Pain (5 questions ranging from 0 - 20), Stiffness (2 questions ranging from 0 - 8) and Function (17 questions ranging from 0 - 68).
Measured: Baseline, 1, 3, 6, and 24 months
Subjective International Knee Documentation Committee (IKDC - subjective score)
Questionnaire is specific for knee pathologies. it is composed by three subscales: Symptoms, Sport Activities and Knee Function. (Total score 0-100)
Measured: Baseline, 1, 3, 6, 12 and 24 months
Objective International Knee Documentation Committee (IKDC-Objective Score)
The presence of effusions and the degree of movement of the knee are evaluated, the worst value of one of these parameters determines the final value of the IKDC degree. There are four grades (A, B, C, D) which respectively identify a knee rated as normal, near normal, abnormal and severely abnormal;
Measured: Baseline, 1, 3, 6, 12 and 24 months
Tegner score
describe and assess the sport activity with a score ranging from 0 to 10, where 0 means "inability" and 10 represent ability to perform "competitive sports".
Measured: Before symptoms onset, at the baseline
Patient Acceptable Symptom State (PASS)
tool for assessing patient satisfaction in consideration of their current degree of pain, function and daily activity. The patient will evaluate his degree of satisfaction by answering a dichotomous closed question (yes / no).
Measured: Baseline, 1, 3, 6, 12 and 24 months
EuroQol Visual Analogue Scale (EQ-VAS)
0 - 100 scale where 100 is the "best possible health"and 0 is the "worst possible health"
Measured: Baseline, 1, 3, 6, 12 and 24 months
Numeric Rating Scale (NRS) - Function
the scale is to expect the patient to select the number that best describes their functional disability status, from 0 to 10. The higher the value indicated the higher the degree of disability will be.
Measured: Baseline, 1, 3, 6, 12 and 24 months
Numeric Rating Scale (NRS) - Pain
the scale requires the patient to select the number that best describes the intensity of his pain, from 0 to 10, at that precise moment. 0 means no pain and 10 means worst possible pain.
Measured: Baseline, 1, 3, 6, 12 and 24 months
Kellgren-Lawrence score
grade 0 to 4 for the assessment of the knee osteoarthritis grade, where 4 is the worst possible grade.
Measured: baseline and 24 months
Magnetic Resonance Imaging
evaluation of the knee joint
Measured: baseline and 12 months
overall judgement on the treatment
The patient must indicate the degree of satisfaction with the treatment carried out at the end of the clinical trial
Measured: 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start22 Feb 2021
- Primary completion22 Apr 2022
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bilateral Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567732
- Sponsor's protocol ID
- AdipoBil
- Status last verified
- Aug 2025
- First submitted
- 23 Sep 2020
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bianchi F, Maioli M, Leonardi E, Olivi E, Pasquinelli G, Valente S, Mendez AJ, Ricordi C, Raffaini M, Tremolada C, Ventura C. A new nonenzymatic method and device to obtain a fat tissue derivative highly enriched in pericyte-like elements by mild mechanical forces from human lipoaspirates. Cell Transplant. 2013;22(11):2063-77. doi: 10.3727/096368912X657855. Epub 2012 Oct 8.
PubMed 23051701Tremolada C, Palmieri G, Ricordi C. Adipocyte transplantation and stem cells: plastic surgery meets regenerative medicine. Cell Transplant. 2010;19(10):1217-23. doi: 10.3727/096368910X507187. Epub 2010 May 4.
PubMed 20444320Perdisa F, Gostynska N, Roffi A, Filardo G, Marcacci M, Kon E. Adipose-Derived Mesenchymal Stem Cells for the Treatment of Articular Cartilage: A Systematic Review on Preclinical and Clinical Evidence. Stem Cells Int. 2015;2015:597652. doi: 10.1155/2015/597652. Epub 2015 Jul 9.
PubMed 26240572Koh YG, Kwon OR, Kim YS, Choi YJ. Comparative outcomes of open-wedge high tibial osteotomy with platelet-rich plasma alone or in combination with mesenchymal stem cell treatment: a prospective study. Arthroscopy. 2014 Nov;30(11):1453-60. doi: 10.1016/j.arthro.2014.05.036. Epub 2014 Aug 6.
PubMed 25108907Bellamy N, Hochberg M, Tubach F, Martin-Mola E, Awada H, Bombardier C, Hajjaj-Hassouni N, Logeart I, Matucci-Cerinic M, van de Laar M, van der Heijde D, Dougados M. Development of multinational definitions of minimal clinically important improvement and patient acceptable symptomatic state in osteoarthritis. Arthritis Care Res (Hoboken). 2015 Jul;67(7):972-80. doi: 10.1002/acr.22538.
PubMed 25581339
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Clinical Study on the Treatment of Bilateral Knee Arthrosis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo
- ClinicalTrials.gov ID
- NCT04567732
- Acronym / sponsor ID
- AdipoBil
- Keywords
- Arthrosis, Osteoarthrosis, Degenerative joint disease, Knee degenerative joint disease., Bilateral, Fat tissue
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- Apr 2026 (estimated)
- First posted
- 28 Sep 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 purpose of the study is to assess the radiological and clinical outcomes comparing two different treatments (Filtered Autologous Adipose Tissue versus Placebo) in patients affecting bilateral knee osteoarthritis.
After be randomized, every patient will be treated in both legs, one leg with Adipose Tissue and the other one with Placebo.
Detailed description
All patients who meet the inclusion criteria and giving written informed consent will be randomized.
Every patient will be treated with a single injection of Filtered Autologous Adipose Tissue in one knee and single injection of Placebo in the other, based on the randomization.
After the treatment patients will be followed up to 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filtered Autologous Adipose Tissue | Experimental | Combination Product: injection of Filtered Autologous Adipose Tissuebased on randomization one of the two knees will be treated with a single injection of Filtered Autologous Adipose Tissue |
| Placebo | Placebo comparator | Drug: Placebobased on randomization one of the two knees will be treated with a single injection of Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- bilateral degenerative chondropathy of the knees showing at least a grade 2-3 kellgren-lawrence classification (absence of severe osteoarthritis)
- An overall Pain subscale score of the Western Ontario and McMaster Universities Osteoarthritis Index between a value of 9 and 19.
- Failure, intended as the persistence of symptomatology, after at least one conservative treatment cycle (pharmacological, physiotherapeutic or infiltrative treatment);
- Ability and informed consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up;
Key exclusion criteria (12 listed)
- Patients incapable of understanding and wanting;
- Diagnosis of leukaemia, known presence of metastatic malignant cells, ongoing or planned chemotherapy;
- Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis resulting from another inflammatory disease; infection with human immunodeficiency virus (HIV), viral hepatitis; chondrocalcinosis;
- Patients with uncontrolled diabetes mellitus;
- Patients with uncontrolled thyroid metabolic disorders;
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 |
|---|---|---|
| injection of Filtered Autologous Adipose TissueSingle injection of Filtered Autologous Adipose Tissue | Combination product | Filtered Autologous Adipose Tissue |
| PlaceboSingle injection of Placebo | Drug | Placebo |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 12 months
It is a 0 - 100 standardized questionnaire widely used for the evaluation of patients with knee osteoarthrosis. The questionnaire is made by three subscale: Pain (5 questions ranging from 0 - 20), Stiffness (2 questions ranging from 0 - 8) and Function (17 questions ranging from 0 - 68).
11 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline, 1, 3, 6, and 24 months
Subjective International Knee Documentation Committee (IKDC - subjective score)
Time frame: Baseline, 1, 3, 6, 12 and 24 months
Objective International Knee Documentation Committee (IKDC-Objective Score)
Time frame: Baseline, 1, 3, 6, 12 and 24 months
Tegner score
Time frame: Before symptoms onset, at the baseline
Patient Acceptable Symptom State (PASS)
Time frame: Baseline, 1, 3, 6, 12 and 24 months
EuroQol Visual Analogue Scale (EQ-VAS)
Time frame: Baseline, 1, 3, 6, 12 and 24 months
Numeric Rating Scale (NRS) - Function
Time frame: Baseline, 1, 3, 6, 12 and 24 months
Numeric Rating Scale (NRS) - Pain
Time frame: Baseline, 1, 3, 6, 12 and 24 months
Kellgren-Lawrence score
Time frame: baseline and 24 months
Magnetic Resonance Imaging
Time frame: baseline and 12 months
overall judgement on the treatment
Time frame: 6, 12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Background: PubMed 23051701Bianchi F, Maioli M, Leonardi E, Olivi E, Pasquinelli G, Valente S, Mendez AJ, Ricordi C, Raffaini M, Tremolada C, Ventura C. A new nonenzymatic method and device to obtain a fat tissue derivative highly enriched in pericyte-like elements by mild mechanical forces from human lipoaspirates. Cell Transplant. 2013;22(11):2063-77. doi: 10.3727/096368912X657855. Epub 2012 Oct 8.
- Background: PubMed 20444320Tremolada C, Palmieri G, Ricordi C. Adipocyte transplantation and stem cells: plastic surgery meets regenerative medicine. Cell Transplant. 2010;19(10):1217-23. doi: 10.3727/096368910X507187. Epub 2010 May 4.
- Background: PubMed 26240572Perdisa F, Gostynska N, Roffi A, Filardo G, Marcacci M, Kon E. Adipose-Derived Mesenchymal Stem Cells for the Treatment of Articular Cartilage: A Systematic Review on Preclinical and Clinical Evidence. Stem Cells Int. 2015;2015:597652. doi: 10.1155/2015/597652. Epub 2015 Jul 9.
- Background: PubMed 25108907Koh YG, Kwon OR, Kim YS, Choi YJ. Comparative outcomes of open-wedge high tibial osteotomy with platelet-rich plasma alone or in combination with mesenchymal stem cell treatment: a prospective study. Arthroscopy. 2014 Nov;30(11):1453-60. doi: 10.1016/j.arthro.2014.05.036. Epub 2014 Aug 6.
- Background: PubMed 25581339Bellamy N, Hochberg M, Tubach F, Martin-Mola E, Awada H, Bombardier C, Hajjaj-Hassouni N, Logeart I, Matucci-Cerinic M, van de Laar M, van der Heijde D, Dougados M. Development of multinational definitions of minimal clinically important improvement and patient acceptable symptomatic state in osteoarthritis. Arthritis Care Res (Hoboken). 2015 Jul;67(7):972-80. doi: 10.1002/acr.22538.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection of Filtered Autologous Adipose Tissue in people with Bilateral Knee Osteoarthritis and Autologous Adipose Tissue, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 12 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: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2025. 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 Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: 12 months). 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 NCT04567732, which also lists 5 linked publications.
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 3 Aug 2025.