Allogeneic bone marrow-derived mesenchymal stromal cells, from selected donors for Delayed union or non-union of long bone fracture

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years old at time of baseline visit"}
• {"criterion_text":"- 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.\tDelayed 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.\tNon-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."}
• {"criterion_text":"- Medical health coverage, including CT at 6- and 12-months post-surgery."}
• {"criterion_text":"- Signed informed consent and willingness to comply with the trial visits and procedures."}

Exclusion criteria

• {"criterion_text":"- Hypertrophic non-unions associated to fracture instability which could be corrected by surgical mechanical stabilization alone (no need of autograft or biological augmentation)."}
• {"criterion_text":"- Impossibility to meet the appointments for the follow-up visits and imaging."}
• {"criterion_text":"- Patients receiving treatment with corticosteroids, immunosuppressive agents, bisphosphonates or denosumab at the time of enrolment."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Multiple delayed union or non-union long bone fractures that may affect functional recovery and healing of the treated injury."}
• {"criterion_text":"- Septic fracture or non-union in an acute, productive stage that requires debridement."}
• {"criterion_text":"- Segmental bone loss requiring specific therapy (bone transport, vascularized graft, large structural allograft, megaprosthesis, etc)."}
• {"criterion_text":"- Any other case that requires a surgical procedure not compliant with the trial."}
• {"criterion_text":"- Surgical contraindication of any cause."}
• {"criterion_text":"- Pregnant women."}
• {"criterion_text":"- Neoplastic disease. Patients considered cancer survivors, carcinoma in situ or basalioma in remission can be included."}
• {"criterion_text":"- Included (or expected to be included in a short term) in an organ transplant waiting list."}

Primary endpoints

• {"endpoint_text":"- Percentage of patients with radiological consolidation (Yes/No) at 12 months after the intervention.","definition_or_measurement_approach":"Determined radiologically as Yes/No at 12 months after the intervention."}

Secondary endpoints

• {"endpoint_text":"- Percentage of patients with radiological bone consolidation (Yes/No) at 6 months after the intervention.","definition_or_measurement_approach":"Determined radiologically as Yes/No at 6 months after the intervention."}
• {"endpoint_text":"- Value of Reborne scale at 6 and 12 months","definition_or_measurement_approach":"Assessment using the Reborne radiological scale at 6 and 12 months."}
• {"endpoint_text":"- Pain score at preoperative, 6 and 12 months after surgery, using Numeric Rating Score (NRS) (from 0 to 10) with and without weight bearing.","definition_or_measurement_approach":"Patient-reported pain measured by Numeric Rating Score (NRS) 0–10 preoperatively and at 6 and 12 months, assessed with and without weight bearing."}
• {"endpoint_text":"- Percentage of patients with reoperation at the callus site (Yes/No) at 6 and 12 months after surgical intervention. Estimated as the number of reoperations in the callus site, over the total number of treated patients.","definition_or_measurement_approach":"Calculated as number of reoperations at the callus site divided by total treated patients at 6 and 12 months (Yes/No per patient)."}
• {"endpoint_text":"- Percentage of patients with bone consolidation (Yes/No) at 6 and 12 months after the intervention. Estimated as the number of bone consolidations, over the total number of treated patients.","definition_or_measurement_approach":"Calculated as number of patients with bone consolidation divided by total treated patients at 6 and 12 months (Yes/No per patient)."}
• {"endpoint_text":"- Volumetric assessment of the regenerated bone, as a percentage of 10cm3 of the affected long bone, applying the Region of Interest methodology using Osirix® software in full CT images, at preoperative, 6 and 12 months after surgery","definition_or_measurement_approach":"CT-based volumetric measurement using Region of Interest methodology with Osirix® software, reported as percentage of 10 cm3 of affected bone preop and at 6 and 12 months."}
• {"endpoint_text":"- Safety endpoints include: - Early complication rate: percentage of patients with complications within the first 3 months after surgery. - Overall complication rate as percentage of patients with local or general complications regarding potential effects of the treatment at any time after surgery.","definition_or_measurement_approach":"Early complication rate = percentage of patients with complications within first 3 months; overall complication rate = percentage of patients with local or systemic complications at any time after surgery."}

Germany

Earliest CTIS Part Ii Submission Date

05-08-2025

Latest Decision Or Authorization Date

29-09-2025

Processing Time Days

55

Number Of Sites

2

Number Of Participants

25

Italy

Earliest CTIS Part Ii Submission Date

01-08-2025

Latest Decision Or Authorization Date

29-09-2025

Processing Time Days

59

Number Of Sites

3

Number Of Participants

15

Spain

Earliest CTIS Part Ii Submission Date

19-08-2025

Latest Decision Or Authorization Date

06-03-2026

Processing Time Days

199

Number Of Sites

1

Number Of Participants

25

France

Earliest CTIS Part Ii Submission Date

17-07-2025

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

235

Number Of Sites

3

Number Of Participants

15

Primary sponsor

Full Name

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"Funded by European Union under HORIZON Research and Innovation action GA nº 101137464","duties_or_roles":"Funded by European Union under HORIZON Research and Innovation action GA nº 101137464","organisation_type":"Funding organisation"}