BridgeMD
A multi-centre, single-arm study to demonstrate the efficacy of bone marrow allogeneic mesenchymal cells combined with biomaterial (combined ATMP) for bone healing in delayed union and non-union after long bone fractures (OrthoAlloUnion).
EU CTIS ID: 2025-520841-60-00
What this study is testing
To determine if the combined treatment of allogeneic hBM-MSCs (ORTHOALLO-BM-MSC) + Biomaterial achieves radiological consolidation in more than 90% of patients at 12 months after surgery for a delayed union or non-union long bone fracture.
- 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
- Age ≥ 18 years old at time of baseline visit
- Diagnostic of traumatic isolated closed or open Gustilo I and II, IIIA and IIIB humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture with one of those two conditions: a. Delayed union, defined as a fracture with no signs of bone healing, with absence of bone bridging and presence of fracture line after 4 to nine months from the acute fracture. b. Non-union, defined as a fracture not healed that meets the following criteria (Weber 1986), at least 9 months after the originating trauma: 1) Insufficient bone bridging to stabilize the fracture after 9 months since trauma and 2) Insufficient bone biological activity in the fracture and 3) failure of previous treatments.
- Medical health coverage, including CT at 6- and 12-months post-surgery.
- Signed informed consent and willingness to comply with the trial visits and procedures.
You likely can't join if
- Hypertrophic non-unions associated to fracture instability which could be corrected by surgical mechanical stabilization alone (no need of autograft or biological augmentation).
- Impossibility to meet the appointments for the follow-up visits and imaging.
- Patients receiving treatment with corticosteroids, immunosuppressive agents, bisphosphonates or denosumab at the time of enrolment.
- Participation in another clinical investigation that could, in the opinion of the investigator, affect the safety of the participant or the validity of the study results. This includes an investigational drug administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer.
- Multiple delayed union or non-union long bone fractures that may affect functional recovery and healing of the treated injury.
- Septic fracture or non-union in an acute, productive stage that requires debridement.
See the full eligibility criteria
- Age ≥ 18 years old at time of baseline visit
- Diagnostic of traumatic isolated closed or open Gustilo I and II, IIIA and IIIB humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture with one of those two conditions: a. Delayed union, defined as a fracture with no signs of bone healing, with absence of bone bridging and presence of fracture line after 4 to nine months from the acute fracture. b. Non-union, defined as a fracture not healed that meets the following criteria (Weber 1986), at least 9 months after the originating trauma: 1) Insufficient bone bridging to stabilize the fracture after 9 months since trauma and 2) Insufficient bone biological activity in the fracture and 3) failure of previous treatments.
- Medical health coverage, including CT at 6- and 12-months post-surgery.
- Signed informed consent and willingness to comply with the trial visits and procedures.
- Hypertrophic non-unions associated to fracture instability which could be corrected by surgical mechanical stabilization alone (no need of autograft or biological augmentation).
- Impossibility to meet the appointments for the follow-up visits and imaging.
- Patients receiving treatment with corticosteroids, immunosuppressive agents, bisphosphonates or denosumab at the time of enrolment.
- Participation in another clinical investigation that could, in the opinion of the investigator, affect the safety of the participant or the validity of the study results. This includes an investigational drug administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer.
- Multiple delayed union or non-union long bone fractures that may affect functional recovery and healing of the treated injury.
- Septic fracture or non-union in an acute, productive stage that requires debridement.
- Segmental bone loss requiring specific therapy (bone transport, vascularized graft, large structural allograft, megaprosthesis, etc).
- Any other case that requires a surgical procedure not compliant with the trial.
- Surgical contraindication of any cause.
- Pregnant women.
- Neoplastic disease. Patients considered cancer survivors, carcinoma in situ or basalioma in remission can be included.
- Included (or expected to be included in a short term) in an organ transplant waiting list.
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, 65+ years, 18-64 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.