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Tibial FracturePhase 2ALLOB-TF2NCT04432389

Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture

A Phase 2 study testing ALLOB in people with Tibial Fracture, run by Bone Therapeutics S.A at 39 sites in 7 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Although the majority of tibial fractures heal normally, some fractures may not heal within the usual time frame and is known as delayed bone healing within 4 to 6 months and absence of bone healing within 9 to 12 months in the most severe case of. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tibial Fracture
What is being tested?
ALLOB
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
178 participants
Where
39 sitesin 7 countries
Study dates
8 Jan 2021to 31 Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women at least 18 years of age
  • Subject diagnosed with a fresh proximal, midshaft or distal tibial fracture with definitive reduction performed with nail(s) and wound closure within 1 week of fracture occurrence
  • Mechanism of injury at risk of DU/NU: fracture occurring because of a high energy impact
  • At increased risk of DU/NU defined by:
  • Severe open fracture (Gustilo-Anderson grade IIIa and IIIb) OR
  • Open (Gustilo-Anderson grade I-II) or closed (Tscherne grade II-III) fracture with at least one additional risk factor among smoking , comminuted fracture or cortical continuity (0-50%)
  • Ability to obtain a written, dated, and signed informed consent prior to any study related procedures and ability to understand and comply with study requirements

Who cannot join

  • Definitive reduction at the fracture site under investigation performed with plate, screw or external fixator
  • Subjects who did not receive a standard antibiotic prophylaxis before definitive reduction at the fracture site under investigation
  • Intra-articular tibial pilon and/or plateau fracture at the site under investigation
  • Known osteomyelitis at the fracture site under investigation
  • Bone defect post-definitive reduction greater than 1cm at least on 2 cortices at the fracture site under investigation
  • Fracture requiring vascular surgery at the site under investigation
Show all 24Show fewer
  • Pathological fractures as judged by the Investigator, such as tumor or metabolic bone disease
  • Bifocal or multifocal fracture at the site under investigation
  • Presence of fever (defined as body temperature ≥ 38°C) or other signs/symptoms suggestive of active infection before randomization
  • Severe brain trauma with a Glasgow Coma Scale (GCS) [3 - 8] or severe spinal cord injury with impossibility of weight-bearing
  • Current or history (within 5 years) of any neoplasia (except for basal cell carcinoma of the skin and for carcinoma in situ of the cervix that has been treated with no evidence of recurrence)
  • Known metabolic diseases potentially interfering with bone healing as judged by the Investigator, such as thyroid dysfunction, Paget disease or severe osteoporosis
  • Planned or history of solid organ transplantation or bone marrow transplantation
  • Known disease, including genetic disease, that may possibly need solid organ transplantation
  • Subject with renal impairment requiring dialysis or with clinically significant renal impairment defined as serum creatinine >2.0 x ULN
  • Clinically significant hepatic function impairment defined as ALT/AST levels > 3x ULN or total bilirubin levels > 2 x ULN
  • Known hematologic disease as evidenced by hematocrit < 25%, white blood cell < 2,500/ul or platelet values < 100,000/ul without another explanation
  • Subject with an history of long standing poorly controlled chronic hypertension or diabetes that could put him at risk of needing a kidney transplant later on according to the Investigator
  • History of hypersensitivity to human biological material including blood and blood derived products
  • Known allergy to DMSO, dextran, gentamicin and any other aminoglycosides
  • Participation in another interventional clinical study within 3 months prior to screening
  • Any chronic intake of medication within one month that might affect bone metabolism or the quality of bone formation such as but not limited to bisphosphonates, teriparatide, systemic steroids, anticoagulant therapies, methotrexate and other immunosuppressant drugs or related immunotherapy
  • Previous (within 10 years) treatment with bisphosphonates
  • Current treatment with bone morphogenic protein or any other osteo-biologic intervention at the site of the tibial fracture

Trial locations and contacts

39 sites in 7 countries.

Olivier Godeaux, MD contact

+32 (0)71 121000

clinicaltrials@bonetherapeutics.com

39 sites in 7 countries

Spain8 sites, 1 recruiting

  • Tf2-Es-09

    Badalona

    Active, not recruiting

  • Tf2-Es-08

    Barcelona, 08036

    Active, not recruiting

  • Tf2-Es-02

    Barcelona

    Study Coordinator

    Recruiting

  • Tf2-Es-03

    Barcelona

    Active, not recruiting

  • Tf2-Es-07

    Barcelona

    Active, not recruiting

  • Tf2-Es-06

    Málaga

    Active, not recruiting

  • Tf2-Es-05

    Pontevedra

    Active, not recruiting

  • Tf2-Es-01

    Terrassa

    Active, not recruiting

Other trials in Spain

Czechia6 sites, 4 recruiting

  • Tf2-Cz-01

    České Budějovice

    Study Coordinator

    Not yet recruiting

  • Tf2-Cz-05

    Jindřichův Hradec

    Active, not recruiting

  • Tf2-Cz-03

    Kladno

    Active, not recruiting

  • Tf2-Cz-04

    Nový Jičín

    Study Coordinator

    Not yet recruiting

  • Tf2-Cz-02

    Prague

    Study Coordinator

    Not yet recruiting

  • Tf2-Cz-06

    Prague

    Study Coordinator

    Not yet recruiting

Other trials in Czechia

Hungary6 sites, 3 recruiting

  • Tf2-Hu-01

    Budapest

    Study coordinator

    Not yet recruiting

  • Tf2-Hu-06

    Eger, 3300

    Active, not recruiting

  • Tf2-Hu-05

    Kaposvár

    Active, not recruiting

  • Tf2-Hu-02

    Pécs

    Active, not recruiting

  • Tf2-Hu-03

    Székesfehérvár

    Study Coordinator

    Recruiting

  • Tf2-Hu-04

    Szolnok

    Study coordinator

    Recruiting

Other trials in Hungary

Poland6 sites, 2 recruiting

  • Tf2-Pl-12

    Kielce

    Active, not recruiting

  • Tf2-Pl-08

    Krakow

    Active, not recruiting

  • Tf2-Pl-02

    Lodz

    Active, not recruiting

  • Tf2-Pl-01

    Szczecin

    Study Coordinator

    Not yet recruiting

  • Ft2-Pl-07

    Warsaw

    Active, not recruiting

  • Tf2-Pl-06

    Warsaw

    Study coordinator

    Recruiting

Other trials in Poland

France5 sites, 1 recruiting

  • Tf2-Fr-06

    Amiens, 80000

    study coordinator

    Not yet recruiting

  • Tf2-Fr-04

    Amiens

    Active, not recruiting

  • Tf2-Fr-01

    Brest

    Active, not recruiting

  • Tf2-Fr-02

    Chambray-lès-Tours

    Active, not recruiting

  • Tf2-Fr-06

    Poitiers

    Active, not recruiting

Other trials in France

Belgium4 sites, 1 recruiting

  • Tf2-Be-05

    Anderlecht, 1070

    Active, not recruiting

  • Tf2-Be-03

    Genk, 3600

    Active, not recruiting

  • Tf2-Be-04

    Leuven

    Active, not recruiting

  • Tf2-Be-01

    Lodelinsart

    Study Coordinator

    Not yet recruiting

Other trials in Belgium

Germany4 sites, 3 recruiting

  • Tf2-de-04

    Giessen

    Study Coordinator

    Not yet recruiting

  • Tf2-de-06

    Lübeck

    Study Coordinator

    Not yet recruiting

  • Tf2-de-02

    Mannheim

    Active, not recruiting

  • Tf2-de-01

    Münster

    Study Coordinator

    Not yet recruiting

Other trials in Germany

About this study

Official title: Phase IIb, Placebo-Controlled, Randomized, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture

Although the majority of tibial fractures heal normally, some fractures may not heal within the usual time frame and is known as delayed bone healing within 4 to 6 months and absence of bone healing within 9 to 12 months in the most severe case of. Several factors can increase the risks of delayed healing complications like, for example, smoking, violent shocks (for example, due to a road accident) or even the type of fracture (an open fracture). The location of the fracture is also an important factor: among the bones of the arms and legs, the tibia is known for being the most at risk for complications. At tibial fracture with several risk factors could lead to delayed complications and interfere with patient daily life and reduce the quality of life.

The study drug, ALLOB®, is constituted of bone cells produced from the bone marrow of healthy adult donors. Preclinical studies have shown that ALLOB® cells are capable of forming bone and repairing fractures. When directly injected into a fracture, ALLOB® should therefore promote the healing of the fracture by re-establishing a healthy environment and stimulating bone production. To date, there is no treatment for fractures considered at risk of delayed complications. The current practice on diagnosis of complications is to wait at least 6-12 months before considering alternative interventions to promote fracture healing. The injection of ALLOB® quickly after the fracture should stimulate bone healing, reduce healing time, reduce complications, and improve the quality of life for the patient. ALLOB® has already shown preliminary evidence of effectiveness in the treatment of delayed bone healing fractures (ALLOB-DU1 clinical trial), including tibial fractures (8 patients). With this study, the Sponsor will evaluate whether ALLOB® promotes the healing of tibial fractures compared with placebo.

Conditions
Tibial Fracture
Being tested
ALLOB, placebo
Medical subject headings
Tibial Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALLOBBiological

    After thawing, ALLOB® is a ready-to-use product for local administration at fracture site.

  • placeboOther

    Placebo injected is a saline solution injectable grade (4 mL of 0.9% NaCl) filled in single-dose vial

Study groups in NCT04432389
Study groupRoleWhat they receive
ALLOBExperimentalSingle injection of ALLOB at fracture site (4 ml)
Receives: Biological: ALLOB
placeboPlacebo comparatorSingle injection of Placebo at fracture site (4 ml)
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. proportion of subjects with a radiological success at Week 12

    A radiological success is defined as a subject with a Radiological Union Score for Tibia (RUST) above the threshold value predictive of a normal bone healing.

    Measured: 12 weeks

Secondary outcomes (2)

  1. Proportion of subjects with radiological success at Week 16, Week 20 and Month 6

    A radiological success is defined as a subject with a Radiological Union Score for Tibia (RUST) above the threshold value predictive of a normal bone healing.

    Measured: 16 weeks - 20 weeks - 6 months

  2. Change in Radiographic Union Score for Tibia (RUST) at Week 12, Week 16, Week 20 and Month 6 compared to baseline visit

    Radiological fracture healing is defined by a radiological fracture union evaluated and adjudicated by Independent Radiologists.

    Measured: weeks 12 - 16 - 20 - 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start8 Jan 2021
  3. Primary completion31 Jul 2022 (estimated)
  4. Study completion31 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
178 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04432389
Sponsor's protocol ID
000013/BT
Acronym
ALLOB-TF2
Status last verified
Jun 2021
First submitted
9 Jun 2020
Last updated
7 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALLOB in people with Tibial Fracture, run by Bone Therapeutics S.A at 39 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Spain, Czechia, Hungary, Poland, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Olivier Godeaux, MD (+32 (0)71 121000, clinicaltrials@bonetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

proportion of subjects with a radiological success at Week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04432389.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.

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