Comparing bone marrow and fat tissue injections for knee osteoarthritis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of two different cellular products, bone marrow aspirate concentrate (BMAC) and minimally manipulated adipose tissue (MM-AT), for treating knee osteoarthritis. Patients with symptomatic unilateral knee OA will be randomly assigned to receive either BMAC or MM-AT through a single intra-articular injection. The study will assess clinical outcomes and potential disease-modifying effects over a 12-month follow-up period using imaging and biological assessments. Additionally, factors influencing treatment response will be analyzed to better understand the efficacy of these interventions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

Study contacts

• Principal investigator: Luca Andriolo, MD — Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
• Study coordinator: Luca Andriolo, MD
• Email: luca.andriolo@ior.it
• Phone: 6366567

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effects of virtual reality on walking in adults with knee osteoarthritis

  This study tests how immersive virtual reality environments—designed to feel safe or to provoke fear—affect walking and worry about movement in adults 50 and older with knee osteoarthritis and in healthy peers.

  Recruiting University of Primorska · Vilnius and 1 other locations · NCT07920120

• Weekly berobenatide for knee osteoarthritis in adults who are overweight or obese

  This study tests whether weekly berobenatide helps reduce knee pain and improve function, while also affecting body weight, in adults with knee osteoarthritis who are overweight or obese (with or without type 2 diabetes).

  Recruiting Phase 3 Pfizer · Birmingham, Alabama and 3 other locations · NCT07915609

• Autologous adipose-derived stem cell injections for knee osteoarthritis

  We’re testing whether injecting a patient’s own fat-derived stem cells into the knee can help people with knee OA feel less pain and move better, compared with a standard hyaluronic acid treatment.

  Recruiting at 3 sites Yonsei University · Incheon and 2 other locations · NCT07901790

• Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty

  This study tests whether higher burden of preoperative multimorbidity affects functional recovery after knee replacement in adults with knee osteoarthritis.

  Recruiting Balikesir Ataturk City Hospital · Balıkesir · NCT07882316

• Cartilage biomarker response to acute loading in knee OA by antiresorptive treatment status

  Researchers will test whether a 30-minute treadmill walk changes cartilage biomarkers in postmenopausal women with knee osteoarthritis, comparing those on denosumab, bisphosphonates, and those not on antiresorptives.

  Recruiting Sisli Hamidiye Etfal Training and Research Hospital · Istanbul, Istanbul · NCT07881861

• Lysyl Enzymes in Knee Osteoarthritis

  This study tests whether blood levels of lysyl hydroxylase and lysyl oxidase differ between people with knee osteoarthritis and healthy individuals.

  Recruiting Afyonkarahisar Health Sciences University · Afyonkarahisar · NCT07875296

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.