NCT05447767: PATTERN

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

Active, enrolled NA Last updated 2 May 2025

What this trial tests

NA trial testing KIT BMAC in Osteoarthritis, Knee in 240 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 September 2021

Primary endpoint
27 March 2023

29 May 2025

Quick facts

Lead sponsor	Istituto Clinico Humanitas
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	240
Start date	27 September 2021
Primary completion	27 March 2023
Estimated completion	29 May 2025
Sites	1 location across Italy

Drugs / interventions tested

• KIT BMAC
• KIT BMAC
• at-SVF FIDIA
• at-SVF FIDIA

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

Istituto Clinico Humanitas

Who can join

Adults 18 to 75, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.