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

Bilateral Knee Osteoarthritis Clinical Trial

Official title:

Randomized Double Blind Clinical Study on the Treatment of Bilateral Knee Arthrosis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04567732
• Other study ID #: AdipoBil
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: October 2025

Study information

• Verified date: July 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: Daniele Andreani, M.Sc.
• Phone: 0516366072
• Email: daniele.andreani[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2025
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. bilateral degenerative chondropathy of the knees showing at least a grade 2-3 kellgren-lawrence classification (absence of severe osteoarthritis)

2. An overall Pain subscale score of the Western Ontario and McMaster Universities Osteoarthritis Index between a value of 9 and 19.

3. Failure, intended as the persistence of symptomatology, after at least one conservative treatment cycle (pharmacological, physiotherapeutic or infiltrative treatment);

4. Ability and informed consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up;

Exclusion Criteria:

1. Patients incapable of understanding and wanting;

2. Diagnosis of leukaemia, known presence of metastatic malignant cells, ongoing or planned chemotherapy;

3. 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;

4. Patients with uncontrolled diabetes mellitus;

5. Patients with uncontrolled thyroid metabolic disorders;

6. Patients who abuse alcoholic beverages, drugs or medicines;

7. Patients with misalignment of the lower limbs above 10 degrees;

8. Body Mass Index > 40;

9. Pregnant or lactating state or intention to become pregnant during the period of participation in the study.

10. Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening.

11. Patients who have had knee surgery in the 12 months prior to screening.

12. Patients with insufficient abdominal adipose tissue, assessed by the investigator

Related Conditions & MeSH terms

• Autologous Adipose Tissue
• Bilateral Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Combination Product:
• injection of Filtered Autologous Adipose Tissue
Single injection of Filtered Autologous Adipose Tissue

Drug:
• Placebo
Single injection of Placebo

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	Baseline, 1, 3, 6, and 24 months
Secondary	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)	Baseline, 1, 3, 6, 12 and 24 months
Secondary	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;	Baseline, 1, 3, 6, 12 and 24 months
Secondary	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".	Before symptoms onset, at the baseline
Secondary	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).	Baseline, 1, 3, 6, 12 and 24 months
Secondary	EuroQol Visual Analogue Scale (EQ-VAS)	0 - 100 scale where 100 is the "best possible health"and 0 is the "worst possible health"	Baseline, 1, 3, 6, 12 and 24 months
Secondary	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.	Baseline, 1, 3, 6, 12 and 24 months
Secondary	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.	Baseline, 1, 3, 6, 12 and 24 months
Secondary	Kellgren-Lawrence score	grade 0 to 4 for the assessment of the knee osteoarthritis grade, where 4 is the worst possible grade.	baseline and 24 months
Secondary	Magnetic Resonance Imaging	evaluation of the knee joint	baseline and 12 months
Secondary	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	6, 12 and 24 months