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ACTIVE NOT RECRUITING

NCT05447767

Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg (PATTERN)

Sponsor: Istituto Clinico Humanitas

View on ClinicalTrials.gov

Summary

Osteoarthritis (OA) is a degenerative joint disease characterised by chronic pain, degradation and loss of articular cartilage, osteophyte formation and varying degrees of synovial inflammation. Today, most of the available conservative treatments provide temporary relief of symptoms but have no effect on the cause and progression of the disease. Mesenchymal stem cells (MSC) have emerged as a durable and effective conservative treatment option for OA. They are tissue cell-rich concentrates that have demonstrated immunomodulatory activities in several in vitro and in vivo studies, particularly in orthopaedics. Thus, "minimal handling" methods for the intraoperative production of tissue cell-rich concentrates has become a widespread strategy in clinical practice. In particular, bone marrow aspirate concentrate (BMAC) and adipose tissue enriched SVF (at-SVF), i.e. the so-called 'orthobiologics', have proven to be cost-effective and promising sources with a high safety profile and positive short-term clinical results. Despite growing evidence on the use of orthobiologics, the different methods of preparation and administration and the lack of meaningful data collection do not allow for a clear understanding of the true efficacy of these treatments, resulting in a lack of patient-specific indications. Although the most common method of administering regenerative Although the most common method of administering regenerative medicinal products is by intra-articular injection, more recently it has been shown that in patients with OA the subchondral bone also undergoes significant pathological changes. Given this evidence, intra-osseous (bone-cartilage interface) injections of biological products may represent a promising approach.

Official title: Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg. (CO-2019-12370720 Prof. Kon BANDO DI RICERCA FINALIZZATA 2019)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2021-09-27

Completion Date

2025-05-29

Last Updated

2025-05-02

Healthy Volunteers

Conditions

Osteoarthritis, Knee

Interventions

DEVICE

KIT BMAC

intra-articular infiltration of BMAC

DEVICE

KIT BMAC

intra-articular and intra-osseous infiltration of BMAC

DEVICE

at-SVF FIDIA

intra-articular infiltration of at-SVF

DEVICE

at-SVF FIDIA

intra-articular and intra-osseous infiltration of at-SVF

Inclusion Criteria: 1. Patients aged 18-75; 2. Patients affected by knee OA KL 2-3; 3. Patients understanding the nature of the study and providing their informed consent to participation; 4. Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol; 5. Body mass index (BMI) ≤ 40 kg/m2; 6. Ability to provide written informed consent and can understand and comply with the requirements of the study. Exclusion Criteria: A 4-arms randomized clinical trial in 240 patients affected by knee OA KL 2-3. Treatment groups: 1) intra-articular injection of BMAC, 2) intra-osseous and intra-articular injection of BMAC, 3) intra-articular injection of adipose tissue enriched in SVF (at-SVF) , 4) intraosseous and intra-articular injection of at-SVF. Inclusion criteria: 1. Patients aged 18-75; 2. Patients affected by knee OA KL 2-3; 3. Patients understanding the nature of the study and providing their informed consent to participation; 4. Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol; 5. Body mass index (BMI) ≤ 40 kg/m2; 6. Ability to provide written informed consent and can understand and comply with the requirements of the study. Exclusion criteria: 1. Patients with known inflammatory diseases at the time of enrolment. 2. Patients who are not allowed to undergo the study procedures involving imaging (X-rays, MRI) based on Investigator's judgement. 3. A history of local anaesthetic and anticoagulant drug allergy; 4. Clinically observed active infection in the index knee joint or skin disease/breakdown or infection in the area of the planned injection site of the index knee; 5. Major surgery (e.g. osteotomy) of the index knee within 12 months prior to screening; 6. Minor surgery (e.g. shaving or arthroscopy) of the index knee within 6 months prior to screening; 7. Patients who received intra-articular injection of corticosteroids, PRP or HA within the previous 3 months; 8. Use of systemic immunosuppressants within 6 weeks prior to screening; 9. Patients with a history of invasive malignancies (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years; 10. Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment. 11. Women who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical investigation and for three months later.

Locations (1)

Humanitas Research Hospital

Rozzano, Milan, Italy

Clinical Research Directory

Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg (PATTERN)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)