Osteoarthritis Knees BothNCT07121556
Treatment of Symptomatic Bilateral Knee Osteoarthritis: Intra-articular Injection of Autologous Microfragmented Adipose Tissue and Hyaluronic Acid vs Intra Articular Injection of Autologous Microfragmented Adipose Tissue
A study of Osteoarthritis Knees Both, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The HYALOFAT study is a randomized controlled double-blind trial with parallel treatment arms and 1:1 allocation. By means of a double-blind randomized controlled trial in patients with symptomatic bilateral OA of the knees, the clinical outcomes of autologous microfragmented adipose tissue injection associated with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis Knees Both
- 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
- 29 Sep 2025to Sep 2030
- 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
- Male or female patients aged between 18 and 75;
- Radiographic evidence of bilateral OA of the knees graded between 2 and 4 on the Kellgren-Lawrence scale;
- Pain equal to or greater than 4 on the Numeric Rating Scale (NRS) for both knees;
- Failure, defined as persistence of symptoms after at least 6 months of conservative treatment (pharmacological, physiotherapy, or infiltration treatment);
- Ability and willingness to undergo the study procedures and comply with the instructions given by the study team; 6. No history of
- 4. Failure, defined as persistent symptoms, after at least 6 months of conservative treatment (pharmacological, physiotherapy, or infiltration treatment); 5. Ability and consent of patients to actively participate in the rehabilitation and follow-up protocol; 6. Signature of informed consent
Who cannot join
- Patients incapable of understanding and willing;
- Diagnosis of active neoplasia;
- Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis resulting from another inflammatory disease; human immunodeficiency virus (HIV) infection, active viral hepatitis; chondrocalcinosis;
- Patients with uncontrolled diabetes mellitus;
- Patients with uncontrolled thyroid metabolic disorders;
- Patients who abuse alcohol, drugs, or medications;
Show all 12Show fewer
- Patients with lower limb misalignment greater than 5°;
- Body Mass Index > 35 kg/m2;
- Pregnancy or breastfeeding, or plans to become pregnant during the study period .
- Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening.
- Patients who have undergone knee surgery in the 12 months prior to screening.
- Patients with insufficient abdominal adipose tissue, as assessed by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40127
Alessandro Di Martino, MD, 0516366567, alessandro.dimartino@ior.it
Roberta Licciardi, MsC, 0516366567, roberta.licciardi@ior.it
About this study
Official title: Randomized Double- Blind Study on the Treatment of Symptomatic Bilateral Knee Osteoarthritis: Intra-articular Injection of Autologous Microfragmented Adipose Tissue and Hyaluronic Acid vs Intra Articular Injection of Autologous Microfragmented Adipose Tissue. Double-Blind Randomized Controlled Clinical Trial
The HYALOFAT study is a randomized controlled double-blind trial with parallel treatment arms and 1:1 allocation.
By means of a double-blind randomized controlled trial in patients with symptomatic bilateral OA of the knees, the clinical outcomes of autologous microfragmented adipose tissue injection associated with hyaluronic acid in one knee vs autologous microfragmented adipose tissue injection in the contralateral knee will be evaluated and compared. Each patient will then serve as his or her own control and not be informed of the knee assigned to the treatment group. In addition, it will be the aim of the study to evaluate the safety of the combined treatment by documenting any adverse events.
Read the detailed description
100 patients with symptomatic bilateral knee OA will be included in a randomized controlled double-blind study in which the clinical outcomes of treating OA with microfragmented autologous adipose tissue associated with high-molecular-weight hyaluronic acid versus treatment with microfragmented autologous adipose tissue will be evaluated and compared. One knee will be treated with an injection of high-molecular-weight hyaluronic acid (4 cc) and microfragmented autologous adipose tissue (6 cc), harvested from the abdominal site. The contralateral knee will be treated with microfragmented autologous adipose tissue (6 cc), also harvested from the abdominal site by liposuction and microfragmentation, combining an injection of 4 cc of saline (NaCl 0.9%) to make the volume of product injected into both knees equal. During screening, the eligibility of potentially enrollable subjects will be assessed.Once they are deemed eligible, the baseline visit will be performed, which will take place in the divisional or research clinic.
This will include: - the presentation of the study, the collection of informed consents and the administration and collection of subjective and objective evaluation questionnaires by medical staff. Patients will be clinically evaluated at 0-2-6-12 and 24 months follow-up
- Conditions
- Osteoarthritis Knees Both
- Being tested
- MFAT + HA left knee - MFAT + placebo right knee, MFAT + HA right knee - MFAT + placebo left knee
- Keywords
- Osteoarthritis, Knees, HA, Micro-fragmented autologous adipose tissue, Hyaluronic acid, Intra-articular injection, Randomized double-blind study
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MFAT + HA left knee - MFAT + placebo right kneeDevice
The left knee will be treated with an injection of high-molecular-weight hyaluronic acid (4 cc) and microfragmented autologous adipose tissue (6 cc), harvested from the abdominal site.The right knee will be treated with microfragmented autologous adipose tissue (6 cc), also harvested from the abdominal site by liposuction and microfragmentation, combined with an injection of 4 cc of saline (NaCl 0.9%)
MFAT + HA right knee - MFAT + placebo left kneeBiological
The right knee will be treated with an injection of high-molecular-weight hyaluronic acid (4 cc) and microfragmented autologous adipose tissue (6 cc), harvested from the abdominal site.The left knee will be treated with microfragmented autologous adipose tissue (6 cc), also harvested from the abdominal site by liposuction and microfragmentation, combined with an injection of 4 cc of saline (NaCl 0.9%)
| Study group | Role | What they receive |
|---|---|---|
| MFAT + HA left knee - MFAT + placebo right knee | Experimental | The left knee will be treated with an injection of high-molecular-weight hyaluronic acid (4 cc) and microfragmented autologous adipose tissue (6 cc), harvested from the abdominal site.The right knee will be treated with microfragmented autologous adipose tissue (6 cc), also harvested from the abdominal site by liposuction and microfragmentation, combined with an injection of 4 cc of saline (NaCl 0.9%) Receives: Device: MFAT + HA left knee - MFAT + placebo right knee |
| MFAT + HA right knee - MFAT + placebo left knee | Active comparator | The right knee will be treated with an injection of high-molecular-weight hyaluronic acid (4 cc) and microfragmented autologous adipose tissue (6 cc), harvested from the abdominal site.The left knee will be treated with microfragmented autologous adipose tissue (6 cc), also harvested from the abdominal site by liposuction and microfragmentation, combined with an injection of 4 cc of saline (NaCl 0.9%) Receives: Biological: MFAT + HA right knee - MFAT + placebo left knee |
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's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient.
It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome
Measured: 12 months
Secondary outcomes (14)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient.
It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome
Measured: baseline, 2,6,24 months
IKDC-Subjective Score
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function.
Measured: baseline, 2,6,12,24 months
IKDC-Objective Score (Objective International Knee Documentation Committee)
The objective assessment scale has seven parameters related to knee function. The presence of effusion and degree of knee movement are assessed, with the worst value of one of these parameters determining the final IKDC grade. There are four grades (A, B, C, D) which identify a knee assessed as normal, near normal, abnormal, and severely abnormal, respectively.
Measured: baseline, 2,6,12,24 months
Patient Acceptable Symptom State (PASS)
A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no.
Measured: baseline, 2,6,12,24 months
EuroQol Visual Analogue Scale (EQ-VAS)
EQ-VAS is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition).
Measured: baseline, 2,6,12,24 months
Functional Numerical Rating Scale (NRS -functional)
It is a one-dimensional quantitative numerical scale for assessing functional impairment on a scale of 11 points; the scale requires the patient to select the number that best describes their state of functional disability, from 0 to 10. The higher the value indicated, the higher the degree of disability.
Measured: baseline, 2,6,12,24 months
Numerical Rating Scale (NRS - pain)
It is a one-dimensional quantitative 11-point pain assessment scale; the scale requires the patient to select the number that best describes the intensity of their pain, from 0 to 10, at that precise moment: 0 means no pain and 10 indicates the worst possible pain.
Measured: baseline, 2,6,12,24 months
Objective parameters- Range of Motion
Evaluation of the Range of Motion for comparative analysis.
Measured: baseline, 2,6,12,24 months
Objective parameters - Circumferences
Bilateral trans- and supra- patellar circumferences measurement for comparative analysis
Measured: baseline, 2,6,12,24 months
Patient expectations regarding treatment
The patient must indicate at baseline what clinical benefits they expect from the treatment according to the question: "What benefits do you expect to obtain from the treatment you will undergo?" The patient can choose from one of the following options: "complete recovery," "much better," "very much better," "a little better," or "no change."
Measured: baseline
Opinion on the treatment
The patient must indicate their level of satisfaction with the treatment received. The patient can choose from one of the following options: "much better," "a little better," "no change," "a little worse," and "much worse."
Measured: 6,12,24 months
Effectiveness of the blinding procedure
The patient is asked the following question: "In which knee do you think the treatment (autologous adipose tissue + hyaluronic acid) was performed?"
Measured: baseline
Safety of the procedure
The characteristics and incidence of any adverse events will be documented.
Measured: baseline, 2,6,12,24 months
Medical history
Recording of data relating to the duration and onset of symptoms, previous operations,level of activity, and cause of injury
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start29 Sep 2025
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis Knees BothStudies 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
- Model description
- This is a randomized controlled double-blind parallel-arm study with 1:1 allocation
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro Di Martino, MD, Principal investigator, Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121556
- Sponsor's protocol ID
- HYALOFAT
- Status last verified
- Dec 2025
- First submitted
- 6 Aug 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Holzbauer M, Priglinger E, Kolle ST, Prantl L, Stadler C, Winkler PW, Gotterbarm T, Duscher D. Intra-Articular Application of Autologous, Fat-Derived Orthobiologics in the Treatment of Knee Osteoarthritis: A Systematic Review. Cells. 2024 Apr 25;13(9):750. doi: 10.3390/cells13090750.
PubMed 38727286Bianchi 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 26240572Van Pham P, Hong-Thien Bui K, Quoc Ngo D, Tan Khuat L, Kim Phan N. Transplantation of Nonexpanded Adipose Stromal Vascular Fraction and Platelet-Rich Plasma for Articular Cartilage Injury Treatment in Mice Model. J Med Eng. 2013;2013:832396. doi: 10.1155/2013/832396. Epub 2013 Jan 16.
PubMed 27006923Jurgens WJ, Kroeze RJ, Zandieh-Doulabi B, van Dijk A, Renders GA, Smit TH, van Milligen FJ, Ritt MJ, Helder MN. One-step surgical procedure for the treatment of osteochondral defects with adipose-derived stem cells in a caprine knee defect: a pilot study. Biores Open Access. 2013 Aug;2(4):315-25. doi: 10.1089/biores.2013.0024.
PubMed 23914338Filardo G, Tschon M, Perdisa F, Brogini S, Cavallo C, Desando G, Giavaresi G, Grigolo B, Martini L, Nicoli Aldini N, Roffi A, Fini M, Kon E. Micro-fragmentation is a valid alternative to cell expansion and enzymatic digestion of adipose tissue for the treatment of knee osteoarthritis: a comparative preclinical study. Knee Surg Sports Traumatol Arthrosc. 2022 Mar;30(3):773-781. doi: 10.1007/s00167-020-06373-y. Epub 2021 Jan 19.
PubMed 33464397Perucca Orfei C, Boffa A, Sourugeon Y, Laver L, Magalon J, Sanchez M, Tischer T, Filardo G, de Girolamo L. Cell-based therapies have disease-modifying effects on osteoarthritis in animal models. A systematic review by the ESSKA Orthobiologic Initiative. Part 1: adipose tissue-derived cell-based injectable therapies. Knee Surg Sports Traumatol Arthrosc. 2023 Feb;31(2):641-655. doi: 10.1007/s00167-022-07063-7. Epub 2022 Sep 14.
PubMed 36104484Vezzani B, Shaw I, Lesme H, Yong L, Khan N, Tremolada C, Peault B. Higher Pericyte Content and Secretory Activity of Microfragmented Human Adipose Tissue Compared to Enzymatically Derived Stromal Vascular Fraction. Stem Cells Transl Med. 2018 Dec;7(12):876-886. doi: 10.1002/sctm.18-0051. Epub 2018 Sep 26.
PubMed 30255987Desando G, Bartolotti I, Martini L, Giavaresi G, Nicoli Aldini N, Fini M, Roffi A, Perdisa F, Filardo G, Kon E, Grigolo B. Regenerative Features of Adipose Tissue for Osteoarthritis Treatment in a Rabbit Model: Enzymatic Digestion Versus Mechanical Disruption. Int J Mol Sci. 2019 May 29;20(11):2636. doi: 10.3390/ijms20112636.
PubMed 31146351Pak J. Regeneration of human bones in hip osteonecrosis and human cartilage in knee osteoarthritis with autologous adipose-tissue-derived stem cells: a case series. J Med Case Rep. 2011 Jul 7;5:296. doi: 10.1186/1752-1947-5-296.
PubMed 21736710Zaffagnini S, Andriolo L, Boffa A, Poggi A, Cenacchi A, Busacca M, Kon E, Filardo G, Di Martino A. Microfragmented Adipose Tissue Versus Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Prospective Randomized Controlled Trial at 2-Year Follow-up. Am J Sports Med. 2022 Sep;50(11):2881-2892. doi: 10.1177/03635465221115821. Epub 2022 Aug 19.
PubMed 35984721Veronesi F, Andriolo L, Salerno M, Boffa A, Giavaresi G, Filardo G. Adipose Tissue-Derived Minimally Manipulated Products versus Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Systematic Review of Clinical Evidence and Meta-Analysis. J Clin Med. 2023 Dec 22;13(1):67. doi: 10.3390/jcm13010067.
PubMed 38202074Qiao X, Yan L, Feng Y, Li X, Zhang K, Lv Z, Xu C, Zhao S, Liu F, Yang X, Tian Z. Efficacy and safety of corticosteroids, hyaluronic acid, and PRP and combination therapy for knee osteoarthritis: a systematic review and network meta-analysis. BMC Musculoskelet Disord. 2023 Nov 30;24(1):926. doi: 10.1186/s12891-023-06925-6.
PubMed 38037038Howlader MAA, Almigdad A, Urmi JF, Ibrahim H. Efficacy and Safety of Hyaluronic Acid and Platelet-Rich Plasma Combination Therapy Versus Platelet-Rich Plasma Alone in Treating Knee Osteoarthritis: A Systematic Review. Cureus. 2023 Oct 18;15(10):e47256. doi: 10.7759/cureus.47256. eCollection 2023 Oct.
PubMed 38022237
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double- Blind Study on the Treatment of Symptomatic Bilateral Knee Osteoarthritis: Intra-articular Injection of Autologous Microfragmented Adipose Tissue and Hyaluronic Acid vs Intra Articular Injection of Autologous Microfragmented Adipose Tissue. Double-Blind Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07121556
- Acronym / sponsor ID
- HYALOFAT
- Conditions
- Osteoarthritis Knees Both
- Keywords
- Osteoarthritis, Knees, HA, Micro-fragmented autologous adipose tissue, Hyaluronic acid, Intra-articular injection, Randomized double-blind study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 13 Aug 2025 (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 HYALOFAT study is a randomized controlled double-blind trial with parallel treatment arms and 1:1 allocation.
By means of a double-blind randomized controlled trial in patients with symptomatic bilateral OA of the knees, the clinical outcomes of autologous microfragmented adipose tissue injection associated with hyaluronic acid in one knee vs autologous microfragmented adipose tissue injection in the contralateral knee will be evaluated and compared. Each patient will then serve as his or her own control and not be informed of the knee assigned to the treatment group. In addition, it will be the aim of the study to evaluate the safety of the combined treatment by documenting any adverse events.
Detailed description
100 patients with symptomatic bilateral knee OA will be included in a randomized controlled double-blind study in which the clinical outcomes of treating OA with microfragmented autologous adipose tissue associated with high-molecular-weight hyaluronic acid versus treatment with microfragmented autologous adipose tissue will be evaluated and compared. One knee will be treated with an injection of high-molecular-weight hyaluronic acid (4 cc) and microfragmented autologous adipose tissue (6 cc), harvested from the abdominal site. The contralateral knee will be treated with microfragmented autologous adipose tissue (6 cc), also harvested from the abdominal site by liposuction and microfragmentation, combining an injection of 4 cc of saline (NaCl 0.9%) to make the volume of product injected into both knees equal. During screening, the eligibility of potentially enrollable subjects will be assessed.Once they are deemed eligible, the baseline visit will be performed, which will take place in the divisional or research clinic.
This will include: - the presentation of the study, the collection of informed consents and the administration and collection of subjective and objective evaluation questionnaires by medical staff. Patients will be clinically evaluated at 0-2-6-12 and 24 months follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled double-blind parallel-arm study with 1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| MFAT + HA left knee - MFAT + placebo right knee | Experimental | Device: MFAT + HA left knee - MFAT + placebo right kneeThe left knee will be treated with an injection of high-molecular-weight hyaluronic acid (4 cc) and microfragmented autologous adipose tissue (6 cc), harvested from the abdominal site.The right knee will be treated with microfragmented autologous adipose tissue (6 cc), also harvested from the abdominal site by liposuction and microfragmentation, combined with an injection of 4 cc of saline (NaCl 0.9%) |
| MFAT + HA right knee - MFAT + placebo left knee | Active comparator | Biological: MFAT + HA right knee - MFAT + placebo left kneeThe right knee will be treated with an injection of high-molecular-weight hyaluronic acid (4 cc) and microfragmented autologous adipose tissue (6 cc), harvested from the abdominal site.The left knee will be treated with microfragmented autologous adipose tissue (6 cc), also harvested from the abdominal site by liposuction and microfragmentation, combined with an injection of 4 cc of saline (NaCl 0.9%) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged between 18 and 75;
- Radiographic evidence of bilateral OA of the knees graded between 2 and 4 on the Kellgren-Lawrence scale;
- Pain equal to or greater than 4 on the Numeric Rating Scale (NRS) for both knees;
- Failure, defined as persistence of symptoms after at least 6 months of conservative treatment (pharmacological, physiotherapy, or infiltration treatment);
- Ability and willingness to undergo the study procedures and comply with the instructions given by the study team; 6. No history of
Key exclusion criteria (12 listed)
- Patients incapable of understanding and willing;
- Diagnosis of active neoplasia;
- Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis resulting from another inflammatory disease; human immunodeficiency virus (HIV) infection, active 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 |
|---|---|---|
| MFAT + HA left knee - MFAT + placebo right kneeThe left knee will be treated with an injection of high-molecular-weight hyaluronic acid (4 cc) and microfragmented autologous adipose tissue (6 cc), harvested from the abdominal site.The right knee will be treated with microfragmented autologous adipose tissue (6 cc), also harvested from the abdominal site by liposuction and microfragmentation, combined with an injection of 4 cc of saline (NaCl 0.9%) | Device | MFAT + HA left knee - MFAT + placebo right knee |
| MFAT + HA right knee - MFAT + placebo left kneeThe right knee will be treated with an injection of high-molecular-weight hyaluronic acid (4 cc) and microfragmented autologous adipose tissue (6 cc), harvested from the abdominal site.The left knee will be treated with microfragmented autologous adipose tissue (6 cc), also harvested from the abdominal site by liposuction and microfragmentation, combined with an injection of 4 cc of saline (NaCl 0.9%) | Biological | MFAT + HA right knee - MFAT + placebo left knee |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 12 months
It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome
14 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: baseline, 2,6,24 months
IKDC-Subjective Score
Time frame: baseline, 2,6,12,24 months
IKDC-Objective Score (Objective International Knee Documentation Committee)
Time frame: baseline, 2,6,12,24 months
Patient Acceptable Symptom State (PASS)
Time frame: baseline, 2,6,12,24 months
EuroQol Visual Analogue Scale (EQ-VAS)
Time frame: baseline, 2,6,12,24 months
Functional Numerical Rating Scale (NRS -functional)
Time frame: baseline, 2,6,12,24 months
Numerical Rating Scale (NRS - pain)
Time frame: baseline, 2,6,12,24 months
Objective parameters- Range of Motion
Time frame: baseline, 2,6,12,24 months
Objective parameters - Circumferences
Time frame: baseline, 2,6,12,24 months
Patient expectations regarding treatment
Time frame: baseline
Opinion on the treatment
Time frame: 6,12,24 months
Effectiveness of the blinding procedure
Time frame: baseline
Safety of the procedure
Time frame: baseline, 2,6,12,24 months
Medical history
Time frame: baseline
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 Dec 2025.
- Background: PubMed 38727286Holzbauer M, Priglinger E, Kolle ST, Prantl L, Stadler C, Winkler PW, Gotterbarm T, Duscher D. Intra-Articular Application of Autologous, Fat-Derived Orthobiologics in the Treatment of Knee Osteoarthritis: A Systematic Review. Cells. 2024 Apr 25;13(9):750. doi: 10.3390/cells13090750.
- 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 27006923Van Pham P, Hong-Thien Bui K, Quoc Ngo D, Tan Khuat L, Kim Phan N. Transplantation of Nonexpanded Adipose Stromal Vascular Fraction and Platelet-Rich Plasma for Articular Cartilage Injury Treatment in Mice Model. J Med Eng. 2013;2013:832396. doi: 10.1155/2013/832396. Epub 2013 Jan 16.
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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.
Alessandro Di Martino, MD principal investigator
Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Osteoarthritis Knees Both, 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 6 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: looking for participants now, as of the sponsor's last update on 3 Dec 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. 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?
Contact Alessandro Di Martino, MD (0516366567, alessandro.dimartino@ior.it), or a site near the patient. 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 NCT07121556, which also lists 19 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 Dec 2025.