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Clinical trials for ATMP

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   44258   clinical trials with a EudraCT protocol, of which   7344   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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    17 result(s) found for: ATMP. Displaying page 1 of 1.
    EudraCT Number: 2022-003359-33 Sponsor Protocol Number: MABS06 Start Date*: 2023-06-21
    Sponsor Name:MUMC
    Full Title: Assess efficacy of intra-arterial autologous myogenic stem cell therapy for m.3243A>G mutation carriers
    Medical condition: Mitochondrial myopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10027710 Mitochondrial myopathy PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003584-11 Sponsor Protocol Number: MACT-IBK-2015 Start Date*: 2015-12-11
    Sponsor Name:Medical University Innsbruck
    Full Title: Matrix-associated autologous chrondrocyte transplantation for grade four cartilage lesions of the knee joint - clinical and radiological outcome in correlation to the initial cell count of the cho...
    Medical condition: Cartilage lesion
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004859 10072638 Articular cartilage defect LLT
    18.0 100000004865 10064113 Cartilage allograft LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-003594-28 Sponsor Protocol Number: BCCT2011 Start Date*: 2013-11-07
    Sponsor Name:BioTissue Technologies GmbH
    Full Title: A Comparative Observational Prospective Randomized Open-Label Study on Efficacy of BioSeed®-C and chondrotissue® Treatment of Local Femoral Cartilage Defects in the Knee.
    Medical condition: focal femoral cartilage defects in the knee joint
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004863 10007705 Cartilage damage LLT
    16.1 100000004865 10057104 Cartilage repair LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-001162-42 Sponsor Protocol Number: AIFA-2016-02364896 Start Date*: 2018-08-21
    Sponsor Name:FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
    Full Title: A phase 2 open-label study to evaluate the efficacy of allogeneic human cord blood-derived mesenchymal stromal cells in maintaining remission after immunosuppressive therapy withdrawal in pediatric...
    Medical condition: Steroid dependent nephrotic syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038359 - Renal and urinary disorders 10038359 Renal and urinary disorders SOC
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002395-75 Sponsor Protocol Number: NSR-REP-02 Start Date*: 2018-01-17
    Sponsor Name:NightstaRx Ltd (A Biogen Company)
    Full Title: An Open-Label Safety Study of Retinal Gene Therapy for Choroideremia with Bilateral, Sequential Administration of Adeno-Associated Viral Vector (AAV2) Encoding Rab Escort Protein 1 (REP1)
    Medical condition: Choroideremia (CHM)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10008791 Choroideremia LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-004161-68 Sponsor Protocol Number: AG013-ODOM-201 Start Date*: 2018-10-31
    Sponsor Name:Oragenics, Inc.
    Full Title: A Phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of topically-applied AG013 for the attenuation of oral mucositis in subjects with cance...
    Medical condition: Oral mucositis (OM) induced by chemoradiation therapy (CRT) used for the treatment of head and neck cancers (HNC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10028130 Mucositis oral LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Prematurely Ended) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-003958-41 Sponsor Protocol Number: NSR-REP-01 Start Date*: 2016-10-31
    Sponsor Name:NightstaRx Ltd
    Full Title: A Randomised, Open Label, Outcomes-Assessor Masked, Prospective, Parallel Controlled Group, Phase 3 Clinical Trial Of Retinal Gene Therapy For Choroideremia Using An Adeno-Associated Viral Vector (...
    Medical condition: Choroideremia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10008791 Choroideremia LLT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed) FI (Completed) DK (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2009-015002-19 Sponsor Protocol Number: VTI-206 Start Date*: 2010-01-18
    Sponsor Name:VITAL THERAPIES INCORPORATED
    Full Title: EFFICACY AND SAFETY OF ELAD IN SUBJECTS WITH ACUTE ON CHRONIC HEPATITIS (AOCH)
    Medical condition: Acute on Chronic Hepatitis (AOCH)
    Disease: Version SOC Term Classification Code Term Level
    13.1 10019805 - Hepatobiliary disorders 10019755 Hepatitis chronic active PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-000517-33 Sponsor Protocol Number: RP-L201-0318 Start Date*: 2020-07-14
    Sponsor Name:Rocket Pharmaceuticals, Inc.
    Full Title: Gene Therapy for Leukocyte Adhesion Deficiency-I (LAD-I):A Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of the Infusion of Autologous Hematopoietic Stem Cells Transduced with a Len...
    Medical condition: Leukocyte Adhesion Deficiency-I (LAD-I)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018137 Genetic anomalies of leukocytes LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-005140-33 Sponsor Protocol Number: 2015-Adf-L Start Date*: 2016-03-11
    Sponsor Name:Odense Universitets Hospital
    Full Title: Can Fat Derived Stem Cells (SVF) be Used in the Treatment of Erectile Dysfunction After Prostatectomy- randomized, placebo-controlled, double-blind clinical trial.
    Medical condition: Erectile Dysfunction Impotence of origanic origin
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004872 10021550 Impotence LLT
    18.1 100000004872 10021551 Impotence of organic origin LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003421-28 Sponsor Protocol Number: TUD-HINKL1-059 Start Date*: 2014-07-10
    Sponsor Name:Technische Universität Dreden
    Full Title: Randomised controlled phase-2 trial to determine the efficacy of adoptive immunotherapy with haploidentical natural killer cells in high-risk acute myeloid leukemia
    Medical condition: Newly diagnosed high-risk AML other than acute promyelocytic leukemia, ≥20% blasts
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004529-14 Sponsor Protocol Number: VTL-308 Start Date*: 2016-02-08
    Sponsor Name:Vital Therapies, Inc.
    Full Title: A RANDOMIZED, OPEN-LABEL, MULTICENTER, CONTROLLED, PIVOTAL STUDY TO ASSESS SAFETY AND EFFICACY OF ELAD® IN SUBJECTS WITH ALCOHOL-INDUCED LIVER DECOMPENSATION (AILD)
    Medical condition: Alcohol-Induced Liver Decompensation (AILD)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DE (Prematurely Ended) IE (Prematurely Ended) AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001884-21 Sponsor Protocol Number: VTI-210 Start Date*: 2013-07-26
    Sponsor Name:VITAL THERAPIES INCORPORATED
    Full Title: A RANDOMIZED, OPEN-LABEL, MULTICENTER, CONTROLLED STUDY TO ASSESS SAFETY AND EFFICACY OF ELAD IN SUBJECTS WITH SEVERE ACUTE ALCOHOLIC HEPATITIS (SAAH) AND LILLE SCORE FAILURE
    Medical condition: Severe Acute Alcoholic Hepatitis (sAAH)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10019805 - Hepatobiliary disorders 10019755 Hepatitis chronic active PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001177-32 Sponsor Protocol Number: HEP101 Start Date*: 2016-08-09
    Sponsor Name:Promethera Biosciences
    Full Title: Multicenter Phase II Safety and Preliminary Efficacy Study of 2 dose regimens of HepaStem in Patients with Acute on Chronic Liver Failure
    Medical condition: The study will recruit cirrhotic patients who are hospitalized for Acute-on-chronic liver failure (ACLF) or Acute Decompensation at risk of developing ACLF. ACLF combines an acute deterioration of...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004871 10008954 Chronic liver disease and cirrhosis LLT
    20.1 100000004871 10049844 Acute liver failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) ES (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2017-003104-42 Sponsor Protocol Number: NSR-CHM-OS2(273CH201) Start Date*: 2018-01-05
    Sponsor Name:NightstaRx Ltd (A Biogen Company)
    Full Title: A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Retinal Gene Therapy in Subjects with Choroideremia Previously Treated with Adeno-Associated Viral Vector Encoding Rab Escort Prot...
    Medical condition: Choroideremia (CHM) X-Linked Retinitis Pigmentosa (XLRP)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10008791 Choroideremia LLT
    20.0 10010331 - Congenital, familial and genetic disorders 10038914 Retinitis pigmentosa PT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Trial now transitioned) GB (GB - no longer in EU/EEA) FI (Completed) FR (Trial now transitioned) DK (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-005563-27 Sponsor Protocol Number: VTI-208 Start Date*: 2013-07-26
    Sponsor Name:Vital Therapies, Inc.
    Full Title: A RANDOMIZED, OPEN-LABEL, MULTICENTER, CONTROLLED STUDY TO ASSESS SAFETY AND EFFICACY OF ELAD IN SUBJECTS WITH ALCOHOL-INDUCED LIVER DECOMPENSATION (AILD)
    Medical condition: Alcohol-induced liver decompensation (AILD)
    Disease: Version SOC Term Classification Code Term Level
    17.0 10019805 - Hepatobiliary disorders 10019755 Hepatitis chronic active PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    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
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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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