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Bone Marrow Versus Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status

Not yet recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Bone marrow aspirate concentrate injection

intra-articular injection of Minimally manipulated adipose tissue

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring bone marrow aspirate concentrate, minimally manipulated adipose tissue, BMAC, MM-AT, intra-articular injection, knee injection, mesenchymal stromal cells, Randomized controlled trial, cellular orthobiological products

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with symptomatic unilateral knee OA with: Men or women aged 40 to 75 years; Signs and symptoms of OA with a clinical history of gonalgia or swelling for at least 6 months; Radiographic signs of OA (Kellgren-Lawrence grade 1-4); No benefit after at least 4 months of conservative treatment; Ability and consent of patients to actively participate in clinical and radiological (rx and MRI) follow-up; Signing of informed consent. Exclusion Criteria: Patients unable to express consent; Patients aged < to 40 and > to 75 years; Patients with axial deviations > 5°; Patients who have suffered trauma or undergone intra-articular infiltration of other substance in the previous 6 months; Patients who have undergone knee surgery in the previous 12 months; Patients with concomitant knee injuries causing joint pain or swelling (-focal full-thickness osteochondral defects, acute meniscal injuries); Patients with malignant neoplasms; Patients with uncompensated systemic diseases (rheumatic diseases, metabolic disorders such as diabetes and thyroid diseases); Patients with infectious diseases; Patients with histories of alcohol or drug abuse; Patients who are pregnant; Patients with allergies to anesthetics used in the procedure.

Sites / Locations

Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

single intra-articular injection of BMAC

single intra-articular injection of MM-AT

Arm Description

Patients randomized in this group will undergo single knee intra-articular injection of bone marrow aspirate concentrate (BMAC)

Patients randomized in this group will undergo single knee intra-articular injection of minimally manipulated adipose tissue (MM-AT)

Outcomes

Primary Outcome Measures

Western Ontario and McMaster University Osteoarthritis index (WOMAC) - Pain subscale

It is a pathology-specific questionnaire used for the assessment of referred pain at the knee joint level in patients with OA

Secondary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome

Knee Injury and Osteoarthritis Outcome Score (KOOS)

This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines the following categories: symptoms, stiffness, pain, daily activities, sports and quality of life

Visual Analogue Scale (VAS)

Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" (0) and "the strongest pain imaginable" (10).

EuroQol Visual Analogue Scale (EQ-VAS)

EQ-VAS is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition).

Tegner Activity Level Scale

Tegner Activity Level Scale is a questionnaire to find out the patient's level of physical activity.All patients will indicate the type of sporting activity performed and its frequency.

Objective parameters- Range of Motion

Evaluation of the Range of Motion for comparative analysis.

Objective parameters - Circumferences

Bilateral trans- and supra- patellar circumferences measurement for comparative analysis

Patient Acceptable Symptom State (PASS)

A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no.

Minimally Clinical Important Difference (MCID)

The patient should indicate the degree of perceived improvement after the infiltrative procedure.

Expectations about the effectiveness of the treatment

The patient should indicate at baseline what clinical benefits he or she expects from the treatment according to the question, "What benefits do you expect to get as a result of the treatment you will undergo?" the patient can choose from one of the following items:Full recovery, Definitely better, Much better, Slightly better,No change

Kellgren-Lawrence score

The Kellgren Lawrence scale classifies knee OA into 4 grades of subsequent greater severity, the parameters used being reduced joint space and the presence of osteophytes

3 Tesla Nuclear Magnetic Resonance Imaging (3T MRI)

Sequences such as T2-weighted FSE, FS-3D SPGR, and T2 Mapping will be used to assess cartilage thickness and signal, the presence of cysts and subchondral edema, joint profile, the presence of osteophytes and their size, the status of the menisci, both medial and lateral, and the status of the synovium.

Analysis of circulating micro RNAs

miRNAs, involved in OA progression, will be identified and quantified, including miR675-5p, miR-31-5p and miR-33a-5p

Full Information

NCT ID

NCT06040957

First Posted

August 9, 2023

Last Updated

September 10, 2023

Sponsor

Istituto Ortopedico Rizzoli

1. Study Identification

Unique Protocol Identification Number

NCT06040957

Brief Title

Bone Marrow Versus Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis

Official Title

Bone Marrow vs Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis: Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2024 (Anticipated)

Primary Completion Date

January 2027 (Anticipated)

Study Completion Date

January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The MAST-GR study is a randomized controlled interventional trial with parallel treatment arms and 1:1 allocation The primary objective of the study is to compare the safety and efficacy of a single intra-articular infiltration of Bone marrow aspirate concentrate (BMAC) with one of minimally manipulated adipose tissue (MM-AT) so as to determine the most effective cellular product in treating patients with knee osteoarthritis (OA). The secondary objective is to demonstrate whether intra-articular infiltration of BMAC or MM-AT can induce disease-modifying effects in knee OA by imaging and biological assessments on peripheral blood. The tertiary objective of the study is to identify factors that influence the clinical response to treatment (baseline characteristics of patients, biological characteristics of the treated knee, characteristics of cellular products, BMAC and MM-AT).

Detailed Description

Patients with symptomatic unilateral knee OA will be included in a randomized controlled Trial (RCT), in which one group of patients will be treated with 1 intra-articular infiltration of BMAC, and one group will be treated with 1 intra-articular infiltration of MM-AT. A total of 204 patients will be included and will undergo infiltrative treatment after collecting informed consent for study participation and master data. Patients will be clinically evaluated at 0-2-6-12 months follow-up. Possible disease-modifying effects of the two cell products will be investigated by analysis on peripheral blood at 0-2-6-12 months follow-up and by evaluation of radiographic and magnetic resonance imaging (MRI) at 0 and 12 months follow-up. In addition, characterization of the portion of BMAC and MM-AT remaining from treatment will be carried out, as well as baseline assessment of peripheral blood on all patients, and synovial fluid and synovial membrane, where possible, to analyze their influence on clinical outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

bone marrow aspirate concentrate, minimally manipulated adipose tissue, BMAC, MM-AT, intra-articular injection, knee injection, mesenchymal stromal cells, Randomized controlled trial, cellular orthobiological products

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This is a randomized trial with 1:1 allocation.

Masking

Outcomes Assessor

Masking Description

To ensure the blinding of the health care personnel who will perform the checks (single-blind), follow-up visits will be performed by physicians not involved in the treatment procedures.

Allocation

Randomized

Enrollment

204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

single intra-articular injection of BMAC

Arm Type

Experimental

Arm Description

Patients randomized in this group will undergo single knee intra-articular injection of bone marrow aspirate concentrate (BMAC)

Arm Title

single intra-articular injection of MM-AT

Arm Type

Experimental

Arm Description

Patients randomized in this group will undergo single knee intra-articular injection of minimally manipulated adipose tissue (MM-AT)

Intervention Type

Biological

Intervention Name(s)

Bone marrow aspirate concentrate injection

Intervention Description

single intra-articular injection of Bone Marrow aspirate concentrate derived from the patient's iliac crest

Intervention Type

Biological

Intervention Name(s)

intra-articular injection of Minimally manipulated adipose tissue

Intervention Description

single intra-articular injection of Minimally manipulated adipose tissue derived from the patient's abdominal adipose tissue

Primary Outcome Measure Information:

Title

Western Ontario and McMaster University Osteoarthritis index (WOMAC) - Pain subscale

Description

It is a pathology-specific questionnaire used for the assessment of referred pain at the knee joint level in patients with OA

Time Frame

6 months follow-up

Secondary Outcome Measure Information:

Title

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Description

Time Frame

baseline, 2 months, 6 months, 12 months follow-up

Title

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Description

Time Frame

baseline, 2 months, 6 months, 12 months follow-up

Title

Visual Analogue Scale (VAS)

Description

Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" (0) and "the strongest pain imaginable" (10).

Time Frame

baseline, 2 months, 6 months, 12 months follow-up

Title

EuroQol Visual Analogue Scale (EQ-VAS)

Description

EQ-VAS is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition).

Time Frame

baseline, 2 months, 6 months, 12 months follow-up

Title

Tegner Activity Level Scale

Description

Tegner Activity Level Scale is a questionnaire to find out the patient's level of physical activity.All patients will indicate the type of sporting activity performed and its frequency.

Time Frame

baseline, 2 months, 6 months, 12 months follow-up

Title

Objective parameters- Range of Motion

Description

Evaluation of the Range of Motion for comparative analysis.

Time Frame

baseline, 2 months, 6 months, 12 months follow-up

Title

Objective parameters - Circumferences

Description

Bilateral trans- and supra- patellar circumferences measurement for comparative analysis

Time Frame

baseline, 2 months, 6 months, 12 months follow-up

Title

Patient Acceptable Symptom State (PASS)

Description

Time Frame

baseline, 2 months, 6 months, 12 months follow-up

Title

Minimally Clinical Important Difference (MCID)

Description

The patient should indicate the degree of perceived improvement after the infiltrative procedure.

Time Frame

baseline, 2 months, 6 months, 12 months follow-up

Title

Expectations about the effectiveness of the treatment

Description

Time Frame

baseline

Title

Kellgren-Lawrence score

Description

The Kellgren Lawrence scale classifies knee OA into 4 grades of subsequent greater severity, the parameters used being reduced joint space and the presence of osteophytes

Time Frame

baseline, 12 months follow-up

Title

3 Tesla Nuclear Magnetic Resonance Imaging (3T MRI)

Description

Time Frame

baseline, 12 months follow-up

Title

Analysis of circulating micro RNAs

Description

miRNAs, involved in OA progression, will be identified and quantified, including miR675-5p, miR-31-5p and miR-33a-5p

Time Frame

baseline, 2 months, 6 months, 12 months follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luca Andriolo, MD

Phone

6366567

Ext

051

luca.andriolo@ior.it

First Name & Middle Initial & Last Name or Official Title & Degree

Roberta Licciardi, MSc

Phone

6366567

Ext

051

roberta.licciardi@ior.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luca Andriolo, MD

Organizational Affiliation

Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica

Official's Role

Principal Investigator

Facility Information:

Facility Name

Istituto Ortopedico Rizzoli

City

Bologna

ZIP/Postal Code

40136

Country

Italy

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luca Andriolo, MD

Phone

6366567

Ext

051

luca.andriolo@ior.it

First Name & Middle Initial & Last Name & Degree

Roberta Licciardi, MSc

Phone

6366567

Ext

051

roberta.licciardi@ior.it

First Name & Middle Initial & Last Name & Degree

Francesca Veronesi, PhD

First Name & Middle Initial & Last Name & Degree

Alessandro Di Martino, MD

First Name & Middle Initial & Last Name & Degree

Angelo Boffa, MD

First Name & Middle Initial & Last Name & Degree

Stefano Zaffagnini, MD

First Name & Middle Initial & Last Name & Degree

Marco Franceschini, MD

First Name & Middle Initial & Last Name & Degree

Iacopo Romandini, MD

First Name & Middle Initial & Last Name & Degree

Gianluca Giavaresi, MD

First Name & Middle Initial & Last Name & Degree

Viviana Costa, PhD

First Name & Middle Initial & Last Name & Degree

Deyanira Contartese, PhD

First Name & Middle Initial & Last Name & Degree

Silvia Brogini, PhD

First Name & Middle Initial & Last Name & Degree

Melania Maglio, PhD

First Name & Middle Initial & Last Name & Degree

Veronica Borsari, PhD

First Name & Middle Initial & Last Name & Degree

Marco Miceli, MD

First Name & Middle Initial & Last Name & Degree

Paolo Spinnato, MD

12. IPD Sharing Statement

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Bone Marrow Versus Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis

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