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

NCT05447767 · tracked via the Priya Life Science Italy tracker

Sponsor

Istituto Clinico Humanitas

Phase

Not applicable

Started

2021-09-27

Last updated

2025-05-02

Condition(s) studied

Osteoarthritis, Knee

Investigational drug(s) / intervention(s)

KIT BMACKIT BMACat-SVF FIDIAat-SVF FIDIA

KIT BMAC: intra-articular infiltration of BMAC

KIT BMAC: intra-articular and intra-osseous infiltration of BMAC

at-SVF FIDIA: intra-articular infiltration of at-SVF

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Humanitas Research Hospital	Rozzano	Milan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05447767 on ClinicalTrials.gov ↗ ← All trials in Italy