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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

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

11 criteria

  • 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 trial?

15 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

ORTHOALLO-BM-MSC – A cell-based therapeutic product consisting of allogeneic human bone marrow mesenchymal stem cells combined with biomaterial, administered through surgical implantation at the fracture site. This investigational treatment is being studied in clinical trials for treating delayed union and non-union long bone fractures, where normal bone healing has not occurred. The medication works by utilizing the regenerative properties of mesenchymal stem cells to promote bone formation and healing, while the biomaterial provides structural support. This advanced therapy medicinal product (ATMP) represents an innovative approach in orthopedic medicine, specifically designed to address challenging cases of impaired bone healing. Note: Since no other medications are mentioned in the source data, only one description is provided.

Investigated diseases

  • 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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520841-60-00Protocol codeOrtho-Allo-UnionEstimated enrolment80 patientsSponsorFundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda

sourced from the EU Clinical Trials Register and site verification

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