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

NCT05447767 | Active Not Recruiting

• 1 other identifier: 2921
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• The mean KOOS score change from baseline to 12 months.

  KOOS, IKDC and VAS questionnaires will be administered during screening visit and follow-up visits in order to monitor the evolution of the patients. KOOS subscales scores of Pain and Symptoms will be aggregated and averaged as primary outcome.

  12 months

Study Arms (4)

intra-articular injection of BMAC

ACTIVE COMPARATOR

intra-articular injection of BMAC

Device: KIT BMAC

intra-osseous and intra-articular injection of BMAC

ACTIVE COMPARATOR

intra-osseous and intra-articular injection of BMAC

Device: KIT BMAC

intra-articular injection of at- SVF

ACTIVE COMPARATOR

intra-articular injection of at- SVF

Device: at-SVF FIDIA

intraosseous and intra-articular injection of at-SVF

ACTIVE COMPARATOR

intraosseous and intra-articular injection of at-SVF

Device: at-SVF FIDIA

Interventions

KIT BMAC DEVICE

intra-articular infiltration of BMAC

intra-articular injection of BMAC

at-SVF FIDIA DEVICE

intra-articular infiltration of at-SVF

intra-articular injection of at- SVF

Eligibility Criteria

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

You may qualify if:

• Patients aged 18-75;
• Patients affected by knee OA KL 2-3;
• Patients understanding the nature of the study and providing their informed consent to participation;
• Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol;
• Body mass index (BMI) ≤ 40 kg/m2;
• Ability to provide written informed consent and can understand and comply with the requirements of the study.

You may not qualify if:

• 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.
• Patients aged 18-75;
• Patients affected by knee OA KL 2-3;
• Patients understanding the nature of the study and providing their informed consent to participation;
• Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol;
• Body mass index (BMI) ≤ 40 kg/m2;
• Ability to provide written informed consent and can understand and comply with the requirements of the study.
• Patients with known inflammatory diseases at the time of enrolment.
• Patients who are not allowed to undergo the study procedures involving imaging (X-rays, MRI) based on Investigator's judgement.
• A history of local anaesthetic and anticoagulant drug allergy;
• 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;
• Major surgery (e.g. osteotomy) of the index knee within 12 months prior to screening;
• Minor surgery (e.g. shaving or arthroscopy) of the index knee within 6 months prior to screening;
• Patients who received intra-articular injection of corticosteroids, PRP or HA within the previous 3 months;
• Use of systemic immunosuppressants within 6 weeks prior to screening;

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• Ministero della Salute, Italy: collaborator
• Fidia Farmaceutici s.p.a.: collaborator

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: July 7, 2022
• Study Start: September 27, 2021
• Primary Completion: March 27, 2023
• Study Completion: May 29, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)