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

February 27, 2024 updated by: Istituto Ortopedico Rizzoli

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Recruiting
        • Istituto Ortopedico Rizzoli
        • Contact:
        • Sub-Investigator:
          • Marco Franceschini, MD
        • Contact:
        • Sub-Investigator:
          • Francesca Veronesi, PhD
        • Sub-Investigator:
          • Alessandro Di Martino, MD
        • Sub-Investigator:
          • Angelo Boffa, MD
        • Sub-Investigator:
          • Stefano Zaffagnini, MD
        • Sub-Investigator:
          • Iacopo Romandini, MD
        • Sub-Investigator:
          • Gianluca Giavaresi, MD
        • Sub-Investigator:
          • Viviana Costa, PhD
        • Sub-Investigator:
          • Deyanira Contartese, PhD
        • Sub-Investigator:
          • Silvia Brogini, PhD
        • Sub-Investigator:
          • Melania Maglio, PhD
        • Sub-Investigator:
          • Veronica Borsari, PhD
        • Sub-Investigator:
          • Marco Miceli, MD
        • Sub-Investigator:
          • Paolo Spinnato, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients with symptomatic unilateral knee OA with:

  1. Men or women aged 40 to 75 years;
  2. Signs and symptoms of OA with a clinical history of gonalgia or swelling for at least 6 months;
  3. Radiographic signs of OA (Kellgren-Lawrence grade 1-4);
  4. No benefit after at least 4 months of conservative treatment;
  5. Ability and consent of patients to actively participate in clinical and radiological (rx and MRI) follow-up;
  6. Signing of informed consent.

Exclusion Criteria:

  1. Patients unable to express consent;
  2. Patients aged < to 40 and > to 75 years;
  3. Patients with axial deviations > 5°;
  4. Patients who have suffered trauma or undergone intra-articular infiltration of other substance in the previous 6 months;
  5. Patients who have undergone knee surgery in the previous 12 months;
  6. Patients with concomitant knee injuries causing joint pain or swelling (-focal full-thickness osteochondral defects, acute meniscal injuries);
  7. Patients with malignant neoplasms;
  8. Patients with uncompensated systemic diseases (rheumatic diseases, metabolic disorders such as diabetes and thyroid diseases);
  9. Patients with infectious diseases;
  10. Patients with histories of alcohol or drug abuse;
  11. Patients who are pregnant;
  12. Patients with allergies to anesthetics used in the procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single intra-articular injection of BMAC
Patients randomized in this group will undergo single knee intra-articular injection of bone marrow aspirate concentrate (BMAC)
Biological: Bone marrow aspirate concentrate injection
single intra-articular injection of Bone Marrow aspirate concentrate derived from the patient's iliac crest
Experimental: single intra-articular injection of MM-AT
Patients randomized in this group will undergo single knee intra-articular injection of minimally manipulated adipose tissue (MM-AT)
Biological: intra-articular injection of Minimally manipulated adipose tissue
single intra-articular injection of Minimally manipulated adipose tissue derived from the patient's abdominal adipose tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster University Osteoarthritis index (WOMAC) - Pain subscale
Time Frame: 6 months follow-up
It is a pathology-specific questionnaire used for the assessment of referred pain at the knee joint level in patients with OA
6 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: baseline, 2 months, 6 months, 12 months follow-up

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
baseline, 2 months, 6 months, 12 months follow-up
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: baseline, 2 months, 6 months, 12 months follow-up
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
baseline, 2 months, 6 months, 12 months follow-up
Visual Analogue Scale (VAS)
Time Frame: baseline, 2 months, 6 months, 12 months follow-up
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).
baseline, 2 months, 6 months, 12 months follow-up
EuroQol Visual Analogue Scale (EQ-VAS)
Time Frame: baseline, 2 months, 6 months, 12 months follow-up
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).
baseline, 2 months, 6 months, 12 months follow-up
Tegner Activity Level Scale
Time Frame: baseline, 2 months, 6 months, 12 months follow-up
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.
baseline, 2 months, 6 months, 12 months follow-up
Objective parameters- Range of Motion
Time Frame: baseline, 2 months, 6 months, 12 months follow-up
Evaluation of the Range of Motion for comparative analysis.
baseline, 2 months, 6 months, 12 months follow-up
Objective parameters - Circumferences
Time Frame: baseline, 2 months, 6 months, 12 months follow-up
Bilateral trans- and supra- patellar circumferences measurement for comparative analysis
baseline, 2 months, 6 months, 12 months follow-up
Patient Acceptable Symptom State (PASS)
Time Frame: baseline, 2 months, 6 months, 12 months follow-up
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.
baseline, 2 months, 6 months, 12 months follow-up
Minimally Clinical Important Difference (MCID)
Time Frame: baseline, 2 months, 6 months, 12 months follow-up
The patient should indicate the degree of perceived improvement after the infiltrative procedure.
baseline, 2 months, 6 months, 12 months follow-up
Expectations about the effectiveness of the treatment
Time Frame: baseline
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
baseline
Kellgren-Lawrence score
Time Frame: baseline, 12 months follow-up
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
baseline, 12 months follow-up
3 Tesla Nuclear Magnetic Resonance Imaging (3T MRI)
Time Frame: baseline, 12 months follow-up
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.
baseline, 12 months follow-up
Analysis of circulating micro RNAs
Time Frame: baseline, 2 months, 6 months, 12 months follow-up
miRNAs, involved in OA progression, will be identified and quantified, including miR675-5p, miR-31-5p and miR-33a-5p
baseline, 2 months, 6 months, 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Principal Investigator: Luca Andriolo, MD, Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

September 10, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAST-GR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on Bone marrow aspirate concentrate injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe