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

NCT05447767 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-05-02

No results posted yet for this 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.

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

Sponsors & Collaborators

  • Ministero della Salute, Italy

    collaborator OTHER

  • Fidia Farmaceutici s.p.a.

    collaborator INDUSTRY

  • Istituto Clinico Humanitas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-27
Primary Completion
2023-03-27
Completion
2025-05-29

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05447767 on ClinicalTrials.gov