Study of bone marrow mesenchymal cells with biomaterial to treat delayed or non-healing long bone fractures using ORTHOALLO-BM-MSC and MBCP+ in adult patients

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What is this study about?

This study focuses on treating patients with delayed union or non-union long bone fractures, conditions where bones fail to heal properly after a fracture. Delayed union occurs when there are no signs of bone healing between 4 to 9 months after the initial fracture, while non-union refers to fractures that have not healed after 9 months following the injury.

The treatment being studied combines allogeneic bone marrow-derived mesenchymal stromal cells (ORTHOALLO-BM-MSC) with a special bone substitute material called MBCP+. This bone substitute is a ceramic material containing calcium phosphate that helps fill spaces in the bone. The purpose of the study is to determine if this combination treatment can achieve bone healing in patients with delayed or non-healing fractures.

The study will follow patients for 12 months after their surgical procedure. During this time, patients will undergo various evaluations, including imaging tests to check bone healing progress. The treatment involves a surgical procedure where the cell suspension is administered directly into the bone along with the bone substitute material.

1 Initial assessment

You will undergo evaluation to confirm delayed union (bone not healing between 4-9 months after fracture) or non-union (bone not healed after 9 months) of your humerus, tibial, or femur bone fracture.

Medical imaging will be performed to assess your current bone healing status.

2 Surgical procedure

You will receive a surgical treatment that combines ORTHOALLO-BM-MSC (bone marrow cells from selected donors) with a special biomaterial.

The treatment will be administered directly into the bone through a surgical procedure.

3 3-month follow-up

Your recovery will be monitored for early complications during the first 3 months after surgery.

Medical staff will assess your healing progress and address any potential side effects.

4 6-month evaluation

You will undergo a CT scan to assess bone healing progress.

Medical staff will evaluate your pain levels using a scale from 0 to 10, both with and without weight bearing.

The volume of new bone formation will be measured using specialized software.

5 12-month final assessment

A final CT scan will be performed to confirm bone healing.

Pain levels will be reassessed using the same scale as before.

The final volume of new bone formation will be measured.

Medical staff will determine if the bone has successfully healed.

Who Can Join the Study?

  • Must be at least 18 years old at the time of initial visit
  • Must have a traumatic fracture in one of these bones:
    • Humerus (upper arm bone)
    • Tibia (shin bone)
    • Femur (thigh bone)
  • The fracture must be either:
    • Delayed union – a fracture that shows no signs of healing between 4-9 months after injury
    • Non-union – a fracture that has not healed after 9 months and previous treatments have failed
  • Must have medical insurance coverage that includes CT scans (detailed X-ray imaging) at 6 and 12 months after surgery
  • Must be willing to sign an informed consent form
  • Must be able to attend all required study visits and follow study procedures
  • The fracture can be either:
    • Closed (skin intact)
    • Open (with skin break) – limited to Gustilo types I, II, IIIA, and IIIB (classifications of wound severity)

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Pregnancy or breastfeeding
  • Active infection at the fracture site
  • History of malignant tumors (cancer) in the past 5 years
  • Severe systemic diseases that could affect bone healing, such as:
    • Uncontrolled diabetes (high blood sugar)
    • Severe kidney disease
    • Severe liver disease
  • Current treatment with medications that may affect bone healing:
    • Immunosuppressive drugs (medications that reduce immune system activity)
    • Long-term corticosteroids (anti-inflammatory medications)
  • Known allergies to study materials or medications
  • Participation in other clinical trials within the last 30 days
  • Substance abuse or alcohol dependency
  • Mental conditions that could affect the ability to follow study procedures
  • Blood disorders that might affect healing
  • Smoking more than 10 cigarettes per day

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Istituto Ortopedico Rizzoli Bologna Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Hopital Antoine Beclere Clamart France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Cvxder Hnxsxyevcok Rxcdydjf Ubkgmutbrkrde Dd Tfvnh Tours France
Kvhcfqcw dyw Uvzqmkrzvmyx Mdbqneuu Aok Munich Germany
Fbmilarqf Pcqv Lm Ixjydqrdyevdw Bqpttglfx Dwa Hjyokxfm Uopqwuwgrrhus Ls Ptm Madrid Spain
Hgzxbus Hvnsy Mchfvu &vhyxux 1 rzi Gooawes Eoyslc Creteil France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
15.09.2025
Germany Germany
Not yet recruiting
15.09.2025
Italy Italy
Not yet recruiting
15.09.2025
Spain Spain
Recruiting
15.09.2025

Trial locations

ORTHOALLO-BM-MSC (human bone marrow mesenchymal stem cells) is a cell therapy treatment made from donor bone marrow cells. These specialized cells are used to help heal bones that have not properly healed after a fracture. The cells work by promoting new bone formation and supporting the natural healing process.

Biomaterial is a special material designed to be placed at the site of the bone fracture. It acts as a scaffold or support structure that works together with the stem cells to help the bone heal properly. The biomaterial provides a framework for new bone growth and helps keep the stem cells in place where they are needed.

The combination of these two treatments (ORTHOALLO-BM-MSC and Biomaterial) is used together as a single therapy to treat bones that have either delayed healing or failed to heal properly after a fracture.

Delayed Bone Fracture Union – A condition where a broken bone takes longer than expected to heal, typically extending beyond the normal 3-6 month healing period. The healing process is slower than usual but still shows signs of progression, with the bone fragments gradually forming connections.

Non-union Long Bone Fracture – A serious condition where a broken bone fails to heal and unite properly, even after six months from the initial injury. The fracture shows no signs of healing progress over three consecutive months, leaving a persistent break in the bone. This condition most commonly affects major bones in the arms and legs. The broken bone ends remain separated, and natural healing processes have stopped, resulting in continued instability at the fracture site.

Trial ID:
2025-520841-60-00
Protocol code:
Ortho-Allo-Union
Trial Phase:
Therapeutic confirmatory (Phase III)

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