BridgeMD
Phase III, multicentre, randomized, open clinical trial comparing treatment with allogenic mesenchymal cells against autologous mesenchymal cells and against active control with hyaluronic acid in patients with knee osteoarthritis.
EU CTIS ID: 2024-514545-11-00
What this study is testing
To compare the efficacy of allogeneic mesenchymal stem cells (MSC) and autologous MSC versus an active control with hyaluronic acid in terms of clinical, functional and radiological response.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Kellgren and Lawrence grade 2, 3 or 4 gonarthrosis.
- Chronic painful knee with mechanical features.
- Absence of local or systemic septic process.
- Haemacytometric and biochemical analyses without significant alterations contraindicating treatment.
- Written informed consent obtained from the patient.
- The patient is able to understand the nature of the study.
You likely can't join if
- Patient < 18 years old, or legally dependent.
- Patient > 75 years old.
- Congenital or evolutive diseases that result in malformation and/or significant deformities of the knee (varus<10º; valgus<20º) and cause difficulties in the application and evaluation of the results.
- Pregnant or breastfeeding women.
- Neoplastic disease
- Intra-articular infiltration of any drug within 3 months prior to inclusion in the study.
See the full eligibility criteria
- Kellgren and Lawrence grade 2, 3 or 4 gonarthrosis.
- Chronic painful knee with mechanical features.
- Absence of local or systemic septic process.
- Haemacytometric and biochemical analyses without significant alterations contraindicating treatment.
- Written informed consent obtained from the patient.
- The patient is able to understand the nature of the study.
- Body Mass Index between 20 and 35 kg/m2.
- Patient < 18 years old, or legally dependent.
- Patient > 75 years old.
- Congenital or evolutive diseases that result in malformation and/or significant deformities of the knee (varus<10º; valgus<20º) and cause difficulties in the application and evaluation of the results.
- Pregnant or breastfeeding women.
- Neoplastic disease
- Intra-articular infiltration of any drug within 3 months prior to inclusion in the study.
- Concurrent participation in another clinical trial or treatment with another investigational product in the 30 days prior to inclusion in the study.
- Allergy to gentamicin (antibiotic used in the cell culture process).
- Other illnesses or circumstances that might compromise the patient participation in the study according to medical criteria.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.