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).

Overview

Sponsor-declared trial summary

Key facts

Sponsor

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

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

24 Apr 2026 → ongoing

Decision date (initial)

2025-09-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Funded by European Union under HORIZON Research and Innovation action GA nº 101137464

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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.

Secondary objectives 7

1. To determine the radiological consolidation at 6 months after surgery with combined treatment administration.
2. To assess the radiological consolidation by means of the Reborne scale at 6 and 12 months after surgery with combined treatment administration.
3. To assess pain at the fracture site with and without weight bearing at 6 and 12 months after surgery.
4. To determine the reoperation occurrence at 6 and 12 months after surgery with combined treatment administration.
5. To determine the clinical and radiological bone consolidation ratio at 6 and 12 months after surgery and combined treatment administration.
6. To measure the volume of regenerated bone in CT images at preoperative, 6 and 12 months after surgery.
7. To assess clinical safety of the IMP up to 2 years

Conditions and MedDRA coding

Delayed consolidation or non-union long bone fracture

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age ≥ 18 years old at time of baseline visit
2. 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.
3. Medical health coverage, including CT at 6- and 12-months post-surgery.
4. Signed informed consent and willingness to comply with the trial visits and procedures.

Exclusion criteria 12

1. Hypertrophic non-unions associated to fracture instability which could be corrected by surgical mechanical stabilization alone (no need of autograft or biological augmentation).
2. Multiple delayed union or non-union long bone fractures that may affect functional recovery and healing of the treated injury.
3. Septic fracture or non-union in an acute, productive stage that requires debridement.
4. Segmental bone loss requiring specific therapy (bone transport, vascularized graft, large structural allograft, megaprosthesis, etc).
5. Any other case that requires a surgical procedure not compliant with the trial.
6. Surgical contraindication of any cause.
7. Pregnant women.
8. Neoplastic disease. Patients considered cancer survivors, carcinoma in situ or basalioma in remission can be included.
9. Included (or expected to be included in a short term) in an organ transplant waiting list.
10. Impossibility to meet the appointments for the follow-up visits and imaging.
11. Patients receiving treatment with corticosteroids, immunosuppressive agents, bisphosphonates or denosumab at the time of enrolment.
12. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of patients with radiological consolidation (Yes/No) at 12 months after the intervention.

Secondary endpoints 7

1. Percentage of patients with radiological bone consolidation (Yes/No) at 6 months after the intervention.
2. Value of Reborne scale at 6 and 12 months
3. Pain score at preoperative, 6 and 12 months after surgery, using Numeric Rating Score (NRS) (from 0 to 10) with and without weight bearing.
4. 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.
5. 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.
6. 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
7. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

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

Sponsor organisation

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

Address

Calle De Joaquin Rodrigo 2

City

Majadahonda

Postcode

28222

Country

Spain

Scientific contact point

Organisation

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

Contact name

Clinical Trial Coordinator

Public contact point

Organisation

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

Contact name

Clinical Trial Coordinator

Locations

4 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications