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Clinical trials for Safety engineering

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
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    • 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   44334   clinical trials with a EudraCT protocol, of which   7366   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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    25 result(s) found for: Safety engineering. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2005-003759-11 Sponsor Protocol Number: FI 1 Start Date*: 2007-03-09
    Sponsor Name:BKH Schwaz
    Full Title: Autologous myoblasts for treatment of anal incontinence due to anal sphincter defects
    Medical condition: Fecal (anal) inconinence caused by ruptures/ traumas of the external anal sphincter
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-001600-23 Sponsor Protocol Number: HLS02/2008 Start Date*: 2010-01-08
    Sponsor Name:AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
    Full Title: Prospective, randomized, single masked pilot study on the variation of choroidal blood flow analyzed through the HRA dynamic angiography in patients treated with intravitreal injection of Selecti...
    Medical condition: Choroidal neovascularization in patients with age-related macular degeneration.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-003793-26 Sponsor Protocol Number: 3066K1-3311-WW Start Date*: 2008-05-19
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.
    Full Title: Phase 3b, Randomized, Open-Label Study of Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa as First-Line Treatment in Subjects With Advanced Renal Cell Carcinoma
    Medical condition: First-Line Treatment in Subjects with Advanced Renal Cell Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10050513 Metastatic renal cell carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) FR (Completed) BE (Completed) PT (Completed) CZ (Completed) DE (Completed) SK (Completed) NL (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-005798-22 Sponsor Protocol Number: AAG-G-H-1202 Start Date*: 2012-11-05
    Sponsor Name:TETEC – Tissue Engineering Technologies – AG
    Full Title: A Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D plus Compared to Microfracture in the Treatment of Articular Cartilage Defects of the Knee.
    Medical condition: Repair of localized, full-thickness cartilage defects of the femoral condyle (medial, lateral or trochlea) of 2-6cm².
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10052913 Cartilage operation PT
    20.0 100000004863 10007705 Cartilage damage LLT
    20.0 10042613 - Surgical and medical procedures 10057104 Cartilage repair LLT
    20.0 10042613 - Surgical and medical procedures 10064112 Cartilage graft PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) GB (GB - no longer in EU/EEA) CZ (Completed) PL (Completed) HU (Completed) LV (Completed) LT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-000650-38 Sponsor Protocol Number: ALLOB-MF1 Start Date*: 2015-07-01
    Sponsor Name:Bone Therapeutics S.A.
    Full Title: A Phase IIA, multicentre, open study on the safety and efficacy of allogeneic osteoblastic cells (ALLOB®) implantation in multiple non-infected delayed-union (DU) fractures
    Medical condition: Multiple non-infected delayed-union fractures
    Disease: Version SOC Term Classification Code Term Level
    17.1 10028395 - Musculoskeletal and connective tissue disorders 10017081 Fracture delayed union PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-005333-36 Sponsor Protocol Number: ALLOB-DU1 Start Date*: 2013-07-30
    Sponsor Name:Bone Therapeutics S.A.
    Full Title: A pilot Phase I/IIa, multicentre, open proof-of-concept study on the efficacy and safety of allogeneic osteoblastic cells (ALLOB®) implantation in non-infected delayed-union fractures
    Medical condition: Non-infected delayed-union fractures
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10017081 Fracture delayed union PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-002802-34 Sponsor Protocol Number: Sandoz/OMNI/F/01/03 Start Date*: 2015-07-03
    Sponsor Name:Sandoz SAS
    Full Title: Multicentre study to evaluate the efficacy and safety of a liquid formulation of recombinant growth hormone, Omnitrope® 3.3mg/mL, in the treatment of pre-pubertal children of small stature sufferin...
    Medical condition: Small stature secondary to growth hormone insufficiency deficiency
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-004359-18 Sponsor Protocol Number: CCTU/2012/036 Start Date*: 2015-02-02
    Sponsor Name:University College London (UCL) hereby represented by UCL Comprehensive Clinical Trials Unit(CCTU)
    Full Title: RegenVOX: Phase I/IIa clinical trial of stem cell based tissue engineered partial laryngeal implants in adult patients with end-stage laryngotracheal stenosis with 24 months follow-up
    Medical condition: Disorder of Upper Respiratory System Laryngostenosis Tracheal Stenosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10042613 - Surgical and medical procedures 10062034 Laryngeal operation PT
    18.0 10038738 - Respiratory, thoracic and mediastinal disorders 10050816 Tracheal stenosis PT
    18.0 10038738 - Respiratory, thoracic and mediastinal disorders 10023862 Laryngeal stenosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-002817-22 Sponsor Protocol Number: AAG-G-H-1624 Start Date*: 2017-02-09
    Sponsor Name:TETEC Tissue Engineering Technologies - AG
    Full Title: Prospective, Multicenter, Single-arm Phase III Clinical Trial to Evaluate the Efficacy and Safety of NOVOCART® Inject plus in the Treatment of Cartilage Defects of the Knee
    Medical condition: Repair of cartilage defects of the knee (medial or lateral femoral condyle or tibial plateau, trochlea or patella) caused by traumatic events or osteochondritis dissecans (defect size is ≥ 4 and ≤...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000009764 10007702 Cartilage biopsy LLT
    20.0 10042613 - Surgical and medical procedures 10052913 Cartilage operation PT
    20.0 100000019132 10007705 Cartilage damage LLT
    20.0 100000022571 10057104 Cartilage repair LLT
    20.0 10042613 - Surgical and medical procedures 10064112 Cartilage graft PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) DE (Completed) PL (Completed) LT (Completed)
    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)
    EudraCT Number: 2013-004480-31 Sponsor Protocol Number: ALLOB-IF1 Start Date*: 2014-05-27
    Sponsor Name:Bone Therapeutics S.A.
    Full Title: A Pilot Phase IIa, Multicentre, Open, Proof-of-concept Study on the Safety and the Efficacy of Allogeneic Osteoblastic Cells (ALLOB®) implantation in Lumbar Spinal Fusion
    Medical condition: Degenerative disc disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000018941 10070241 Degenerative disc disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001054-96 Sponsor Protocol Number: 000013/BT Start Date*: 2020-03-19
    Sponsor Name:Bone Therapeutics S.A.
    Full 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
    Medical condition: Tibial fracture considered at risk of DU/NU (based on the combination of risk factors documented to be associated with increased proportion of DU/NU).
    Disease: Version SOC Term Classification Code Term Level
    20.0 10022117 - Injury, poisoning and procedural complications 10043827 Tibia fracture PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Ongoing) DE (Prematurely Ended) HU (Prematurely Ended) PL (Prematurely Ended) ES (Ongoing) CZ (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-015985-75 Sponsor Protocol Number: HGT-REP-060 Start Date*: 2010-02-03
    Sponsor Name:Shire Human Genetic Therapies (HGT), Inc.
    Full Title: An Open-label Extension of Study TKT028 Evaluating Safety and Clinical Outcomes of Replagal Enzyme Replacement Therapy Administered to Adult Patients with Fabry Disease
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) CZ (Completed) GB (Completed) FI (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2010-021348-16 Sponsor Protocol Number: HGT-SAN-067 Start Date*: 2011-02-09
    Sponsor Name:Shire Human Genetic Therapies, Inc
    Full Title: An Open-Label Extension of Study HGT-SAN-055 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Administration of rhHNS in Patients with Sanfilippo Syndrome Type A (MPS IIIA)
    Medical condition: Sanfilippo Syndrome Type A or Mucopolysaccharidosis (MPS IIIA)
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10056918 Sanfilippo's syndrome LLT
    19.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-002416-16 Sponsor Protocol Number: ALLOB-RIF1 Start Date*: 2014-08-04
    Sponsor Name:Bone Therapeutics S.A.
    Full Title: A Pilot Phase IIa, Multicentre, Open, Proof-of-concept Study on the Safety and the Efficacy of Allogeneic Osteoblastic Cells (ALLOB®) Implantation in Rescue Interbody Fusion
    Medical condition: Failed lumbar fusion
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000021566 10050238 Spinal fusion NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2011-000536-28 Sponsor Protocol Number: C-10-083 Start Date*: 2011-09-12
    Sponsor Name:Alcon Research Ltd.
    Full Title: Safety and efficacy study with ESBA1008 versus Lucentis for the treatment of exudative age-related macular degeneration
    Medical condition: wet age-related macular degeneration
    Disease: Version SOC Term Classification Code Term Level
    14.1 10015919 - Eye disorders 10064930 Age-related macular degeneration PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2010-022709-16 Sponsor Protocol Number: AT1001-013 Start Date*: 2011-09-12
    Sponsor Name:Amicus Therapeutics, Inc.
    Full Title: AN OPEN-LABEL PHASE 2A STUDY TO INVESTIGATE DRUG-DRUG INTERACTIONS BETWEEN AT1001 (MIGALASTAT HYDROCHLORIDE) AND AGALSIDASE IN SUBJECTS WITH FABRY DISEASE
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adults Gender: Male
    Trial protocol: BE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-005543-22 Sponsor Protocol Number: TKT028 Start Date*: 2008-06-19
    Sponsor Name:Shire Human Genetic Therapies, Inc. (Shire HGT)
    Full Title: A Multi-center, Open-Label, Randomized Study Evaluating the Safety and Efficacy of Three Dosing Regimens of Replagal Enzyme Replacement Therapy in Adult Patients with Fabry Disease
    Medical condition: Fabry Disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) GB (Completed) FI (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2014-003960-20 Sponsor Protocol Number: SHP-610-201 Start Date*: 2015-02-18
    Sponsor Name:Shire human Genetic Therapies, Inc.
    Full Title: A Open-Label Extension of Study HGT-SAN-093 Evaluating the Safety and Efficacy Study of HGT-1410 (Recombinant Human Heparan N Sulfatase) Administration via an Intrathecal Drug Delivery Device in...
    Medical condition: Sanfilippo Syndrome Type A or Mucopolysaccharidosis (MPS IIIA)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10056918 Sanfilippo's syndrome LLT
    17.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) DE (Prematurely Ended) NL (Completed) GB (Prematurely Ended) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-012389-30 Sponsor Protocol Number: Myoblast/ISD/EKS01 Start Date*: 2009-10-02
    Sponsor Name:University Medical Centre Ljubljana, Department of Gynaecology
    Full Title: Transurethral ultrasound-directed injection of autologous myoblasts in combination with functional electrical stimulation in patients with intrinsic urinary sphincter deficiency.
    Medical condition: Stress urinary incontinence due to intrinsic sphincter deficiency (ISD).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10066218 Stress urinary incontinence LLT
    9.1 10066218 Stress urinary incontinence PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: SI (Completed)
    Trial results: (No results available)
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