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Clinical trials for Nonunion

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    12 result(s) found for: Nonunion. Displaying page 1 of 1.
    EudraCT Number: 2010-022909-18 Sponsor Protocol Number: COT-CPMO-3 Start Date*: 2011-03-21
    Sponsor Name:Hospital General de L’Hospitalet
    Full Title: Ensayo clínico Fase II para evaluar la eficacia y seguridad de la aplicación de Células Progenitoras de Médula Ósea Autóloga expandidas en el tratamiento quirúrgico de pseudoartrosis no hipertrófic...
    Medical condition: Pseudoartrosis no hipertróficas de fémur, tibia y húmero, tras un primer fracaso terapéutico
    Disease: Version SOC Term Classification Code Term Level
    13 10017088 Fractura no consolidada LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-005664-10 Sponsor Protocol Number: BMP2/1 Start Date*: 2015-09-30
    Sponsor Name:UZ Leuven Orthopedic research
    Full Title: InductOs® (rhBMP-2; dibotermin alfa) vs. autologous bone grafting for the treatment of nonunion of the docking site in tibial bone transport
    Medical condition: fractured non-healing tibia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2013-000930-37 Sponsor Protocol Number: STEMQUIRI/12ES01 Start Date*: 2014-04-29
    Sponsor Name:Laboratorios Salvat, S.A.
    Full Title: A phase II clinical trial to assess the effect of HC-SVT-1001 (autologous fat stem adult mesenchymal cells expanded and combined with a tricalcium phosphate biomaterial) and HC-SVT-1002 (allogeneic...
    Medical condition: Atrophic pseudarthrosis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10028395 - Musculoskeletal and connective tissue disorders 10048617 Pseudarthrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-004034-11 Sponsor Protocol Number: GR-OG-279239-04 Start Date*: 2022-05-18
    Sponsor Name:Genera Research Ltd
    Full Title: A randomized, evaluator-blinded, dose-ranging, proof of concept study of efficacy, safety and tolerability of Osteogrow-C (rhBMP6 delivered in autologous blood coagulum [ABC] supplemented with sy...
    Medical condition: The treatment of non-union of the tibia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10042613 Surgical and medical procedures SOC
    21.0 10028395 - Musculoskeletal and connective tissue disorders 10017088 Fracture nonunion PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-017039-16 Sponsor Protocol Number: CL3-12911-036 Start Date*: 2010-05-05
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: Effect of strontium ranelate (2g per day) in the management of long bone fractures with delayed-union or non union: an international open label study
    Medical condition: Delayed and non-united fractures
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10017088 Fracture nonunion PT
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10017081 Fracture delayed union PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) FR (Completed) IT (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-000299-13 Sponsor Protocol Number: NVD003-CLN01 Start Date*: 2018-05-17
    Sponsor Name:Novadip Biosciences
    Full Title: A prospective multicentre single-arm study in adults to evaluate the safety and preliminary efficacy of the autologous 3D osteogenic implant NVD-003 for bone reconstruction for the treatment of rec...
    Medical condition: Patients with documented recalcitrant lower limb nonunion, meaning a single, meta- and/or diaphyseal nonunion defect of femur or tibia after at least one failed reconstructive surgical attempt.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) LU (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-001885-14 Sponsor Protocol Number: HN010/HTF-003 Start Date*: 2005-08-24
    Sponsor Name:Henogen s.a.
    Full Title: A phase II, randomised, double blind, matched pair, controlled study to assess the safety and efficacy of Henogen recombinant soluble human tissue factor (rshTF) on the mandible bone consolidation...
    Medical condition: Orthognathic surgery, cases of Bilateral Sagittal Split Osteotomy (B.S.S.O) of the mandible to achieve facial and occlusal balance. This could create bone gaps or continuity defects. These bone gap...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-003697-93 Sponsor Protocol Number: OXITIB2011 Start Date*: 2011-12-15
    Sponsor Name:Hospital Universitario de Canarias
    Full Title: Effectiveness of hyperbaric oxygen therapy in the treatment of the open tibial fractures. Open clinical trial, randomized, prospective and controlled.
    Medical condition: Open tibial fractures
    Disease: Version SOC Term Classification Code Term Level
    14.1 10022117 - Injury, poisoning and procedural complications 10030647 Open fracture of unspecified part of tibia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-005025-23 Sponsor Protocol Number: XCEL-PSART-01 Start Date*: 2014-03-11
    Sponsor Name:Banc de Sang i Teixits (BST)
    Full Title: A phase IIa, unicenter, prospective, randomized, parallel, two-arms, single-dose, open-label with blinded assessor pilot clinical trial to assess ex vivo expanded adult autologous mesenchymal strom...
    Medical condition: pseudarthrosis
    Disease: Version SOC Term Classification Code Term Level
    16.1 10028395 - Musculoskeletal and connective tissue disorders 10048617 Pseudarthrosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2006-004779-36 Sponsor Protocol Number: BMTI-2006-03-EU Start Date*: 2007-01-22
    Sponsor Name:BioMimetic Therapeutic Inc
    Full Title: A Human Clinical Trial to Evaluate the Safety and Clinical Utility of GEM OS1 as a Bone Regeneration System in Foot and Ankle Arthrodesis Procedures
    Medical condition: For use as a bone void filler for voids or gaps that are not intrinsic to the stability of bony structure. Treatment of surgically created osseous defects or osseous defects resulting from patholo...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10061683 Arthrodesis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005584-24 Sponsor Protocol Number: PREOB-NU3 Start Date*: 2012-05-10
    Sponsor Name:Bone Therapeutics S.A.
    Full Title: A pivotal Phase IIb/III, multicentre, randomised, open, controlled study on the efficacy and safety of autologous osteoblastic cells (PREOB®) implantation in non-infected hypotrophic non-union frac...
    Medical condition: Non-infected hypotrophic non-union fractures of long bones
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10048617 Pseudarthrosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-005441-13 Sponsor Protocol Number: C11-12 Start Date*: 2013-01-03
    Sponsor Name:INSERM
    Full Title: Evaluation of efficacy and safety of autologous MSCs combined to biomaterials to enhance bone healing in patients with delayed consolidation after long bone fracture requiring graft apposition or ...
    Medical condition: Closed or open Gustilo I ans II humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10017081 Fracture delayed union PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) IT (Ongoing)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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