Bilateral Knee Osteoarthritis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo

NCT04567732 | Active Not Recruiting DMC

• 1 other identifier: AdipoBil
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. After be randomized, every patient will be treated in both legs, one leg with Adipose Tissue and the other one with Placebo.

Conditions

Bilateral Knee Osteoarthritis; Autologous Adipose Tissue

Keywords

Arthrosis; Osteoarthrosis; Degenerative joint disease; Knee degenerative joint disease.; Bilateral; Fat tissue

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Secondary Outcomes (11)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Baseline, 1, 3, 6, and 24 months

• Subjective International Knee Documentation Committee (IKDC - subjective score)

  Baseline, 1, 3, 6, 12 and 24 months

• Objective International Knee Documentation Committee (IKDC-Objective Score)

  Baseline, 1, 3, 6, 12 and 24 months

• Tegner score

  Before symptoms onset, at the baseline

• Patient Acceptable Symptom State (PASS)

  Baseline, 1, 3, 6, 12 and 24 months

Study Arms (2)

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

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

Drug: Placebo

Interventions

injection of Filtered Autologous Adipose Tissue COMBINATION_PRODUCT

Single injection of Filtered Autologous Adipose Tissue

Filtered Autologous Adipose Tissue

Placebo DRUG

Single injection of Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40124, Italy

Location

Related Publications (5)

• 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.

  PMID: 23051701 BACKGROUND

• Tremolada 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.

  PMID: 20444320 BACKGROUND

• Perdisa 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.

  PMID: 26240572 BACKGROUND

• Koh 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.

  PMID: 25108907 BACKGROUND

• Bellamy 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.

  PMID: 25581339 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Joint Diseases

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 28, 2020
• Study Start: February 22, 2021
• Primary Completion: April 22, 2022
• Study Completion: April 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-08

Locations

IT (1)