Treatment of advanced gastrointestinal cancer with genetically modified autologous mesenchymal stem cells: Results from the phase 1/2 TREAT-ME-1 trial.


Journal

International journal of cancer
ISSN: 1097-0215
Titre abrégé: Int J Cancer
Pays: United States
ID NLM: 0042124

Informations de publication

Date de publication:
15 09 2019
Historique:
received: 17 12 2018
revised: 29 01 2019
accepted: 30 01 2019
pubmed: 26 2 2019
medline: 15 2 2020
entrez: 26 2 2019
Statut: ppublish

Résumé

TREAT-ME-1, a Phase 1/2 open-label multicenter, first-in-human, first-in-class trial, evaluated the safety, tolerability and efficacy of treatment with genetically modified autologous mesenchymal stromal cells (MSC), MSC_ apceth_101, in combination with ganciclovir in patients with advanced gastrointestinal adenocarcinoma. Immunological and inflammatory markers were also assessed. All patients (3 in Phase 1; 7 in Phase 2) received three treatment cycles of MSC_apceth_101 at one dose level on Day 0, 7, and 14 followed by ganciclovir administration according to the manufacturer's instructions for 48─72 h after MSC_apceth_101 injection. Ten patients were treated with a total dose of 3.0 x 10

Identifiants

pubmed: 30801698
doi: 10.1002/ijc.32230
doi:

Substances chimiques

Ganciclovir P9G3CKZ4P5

Types de publication

Clinical Trial, Phase I Clinical Trial, Phase II Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1538-1546

Informations de copyright

© 2019 UICC.

Auteurs

Jobst Christian von Einem (JC)

Department of Medical Oncology and Comprehensive Cancer Center, University Hospital Grosshadern, LMU, Munich, Germany.

Christine Guenther (C)

Apceth GmbH & Co. KG, Munich, Germany.

Hans-Dieter Volk (HD)

Institute for Medical Immunology and Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Charité-Universitätsmedizin, Berlin, Germany.

Gerald Grütz (G)

Institute for Medical Immunology and Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Charité-Universitätsmedizin, Berlin, Germany.

Daniela Hirsch (D)

Apceth GmbH & Co. KG, Munich, Germany.

Christoph Salat (C)

Medizinisches Zentrum für Haematologie und Onkologie Muenchen MVZ GmbH, Munich, Germany.

Oliver Stoetzer (O)

Medizinisches Zentrum für Haematologie und Onkologie Muenchen MVZ GmbH, Munich, Germany.

Peter J Nelson (PJ)

Department of Medicine IV, University Hospital of Munich, LMU, Munich, Germany.

Marlies Michl (M)

Department of Medical Oncology and Comprehensive Cancer Center, University Hospital Grosshadern, LMU, Munich, Germany.

Dominik P Modest (DP)

Department of Medical Oncology and Comprehensive Cancer Center, University Hospital Grosshadern, LMU, Munich, Germany.

Julian W Holch (JW)

Department of Medical Oncology and Comprehensive Cancer Center, University Hospital Grosshadern, LMU, Munich, Germany.

Martin Angele (M)

Department of General, Visceral, and Transplant Surgery, Ludwig-Maximilians-University Munich, Munich, Germany.

Christiane Bruns (C)

General, Visceral and Cancer Surgery, University Hospital of Cologne, Cologne, Germany.

Hanno Niess (H)

Department of General, Visceral, and Transplant Surgery, Ludwig-Maximilians-University Munich, Munich, Germany.

Volker Heinemann (V)

Department of Medical Oncology and Comprehensive Cancer Center, University Hospital Grosshadern, LMU, Munich, Germany.

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