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Clinical trials for Biosurgery

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   44339   clinical trials with a EudraCT protocol, of which   7369   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 ).  
     
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    9 result(s) found for: Biosurgery. Displaying page 1 of 1.
    EudraCT Number: 2006-005092-18 Sponsor Protocol Number: CS I-020502/01 Start Date*: 2007-01-08
    Sponsor Name:KUROS BIOSURGERY AG
    Full Title: A phase 2a, multi-centre, controlled study of the safety and efficacy of wound healing gel I-020502 in patients undergoing autologous meshed skin grafting.
    Medical condition: Deep partial-thickness and full-thickness burns require grafting procedures to achieve wound healing and closure. Autologous grafting eliminates the risk of transmissible diseases but may be compli...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10053615 Thermal burn LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-003688-30 Sponsor Protocol Number: CS I-040101/02 Start Date*: 2007-02-27
    Sponsor Name:Kuros Biosurgery AG
    Full Title: A phase 2 randomized, controlled, open-label (dose-blinded), multi-center, dose-finding study of the safety and efficacy of I-0401 in the treatment of patients with fractures of the tibial plateau ...
    Medical condition: Fractures of the tibial plateau requiring grafting
    Disease: Version SOC Term Classification Code Term Level
    13.1 10028395 - Musculoskeletal and connective tissue disorders 10024956 Lower limb fractures HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) ES (Completed) IT (Completed) FR (Completed) HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-005128-18 Sponsor Protocol Number: CS I – 020201/01 Start Date*: 2009-03-20
    Sponsor Name:Kuros Biosurgery AG
    Full Title: A randomized, multi-center, controlled, parallel group, dose finding study of the efficacy and safety of topically applied I-020201 as an adjunct to good standard-of-care versus good standard-of-ca...
    Medical condition: Chronic diabetic foot ulcers
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012664 Diabetic foot ulcer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-004226-16 Sponsor Protocol Number: ACOT 2.0 Start Date*: 2008-10-07
    Sponsor Name:Carbylan BioSurgery, Inc.
    Full Title: A prospective, multi-center, randomized, controlled, single-blinded study to evaluate the safety and efficacy of AdvaCoat Mx sinus gel for treatment of chronic rhinosinusitis without nasal polyps.
    Medical condition: Subjects with chronic rhinosinusitis without nasal polyps, who have not had previous sinus surgery might be eligible for participation in this trial.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052106 Rhinosinusitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-005093-40 Sponsor Protocol Number: CS I-040202/01 Start Date*: 2007-10-22
    Sponsor Name:Kuros Biosurgery AG
    Full Title: A phase II randomized, controlled, open-labeled (dose-blinded) dose finding study of the safety and efficacy of I-040202 in the treatment of patients with acute open tibial shaft fractures
    Medical condition: Acute open tibial shaft fractures
    Disease: Version SOC Term Classification Code Term Level
    9.1 10024956 Lower limb fractures HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) HU (Completed) SI (Completed) FI (Completed) CZ (Completed) SK (Completed) IT (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-002117-30 Sponsor Protocol Number: 000010/BT Start Date*: 2016-02-16
    Sponsor Name:Bone Therapeutics S.A.
    Full Title: A Two-stage 6-month, Multicentre, Randomised, Double-blind, Controlled Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Patients with Symptomatic Knee Osteo...
    Medical condition: Symptomatic osteoarthritis of the knee with Kellgren-Lawrence grade II and III
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10023476 Knee osteoarthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2008-005115-17 Sponsor Protocol Number: CS I-020502/02 Start Date*: 2009-09-23
    Sponsor Name:Kuros Biosurgery AG
    Full Title: A phase 2b, multi-centre, randomized, intra-patient-controlled dose-finding study of I-020502 in patients undergoing autologous meshed skin grafting.
    Medical condition: acute wounds / deep partial and full thickness burns
    Disease: Version SOC Term Classification Code Term Level
    9.1 10043418 Thermal burns HLT
    9.1 10006802 Burns second degree LLT
    9.1 10006803 Burns third degree LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-001294-18 Sponsor Protocol Number: CS I-040302/01 Start Date*: 2007-09-06
    Sponsor Name:Kuros Biosurgery AG
    Full Title: A phase 2 randomised, open-label, multi-centre ascending dose study of the efficacy, safety and tolerability of I-040302 versus control injection (bone marrow aspirate or steroids) in children and ...
    Medical condition: Solitary Bone Cysts
    Disease: Version SOC Term Classification Code Term Level
    9.1 10041309 Solitary bone cyst LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) SK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-000796-16 Sponsor Protocol Number: 000014/BT Start Date*: 2020-03-03
    Sponsor Name:Bone Therapeutics SA
    Full Title: A Multicenter, Randomized, Double-blind, Placebo- and Active-Controlled Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoart...
    Medical condition: Symptomatic osteoarthritis of the knee with Kellgren-Lawrence grade II and III
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004859 10023476 Knee osteoarthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) BE (Completed) GB (GB - no longer in EU/EEA) PL (Completed) CZ (Completed)
    Trial results: View results
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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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