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

International Journal of Cancer. Journal International Du Cancer
Jobst C von EinemVolker Heinemann

Abstract

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 106 cells/kg MSC_apceth_101. 36 adverse events and six serious adverse events were reported. Five patients achieved stable disease (change in target lesions of -2 to +28%). For all patients, the median time to progression was 1.8 months (95% CI: 0.5, 3.9 months). Median overall survival could not be estimated as 8/10 patients were still alive at the end of the study (1 year) and therefore censored. Post-study observation of patients showed a median overall survival of 15.6 months (ranging from 2.2─27.0 months). Treatment with MSC_apceth_101 and g...Continue Reading

References

Oct 21, 2005·Cytotherapy·E M HorwitzUNKNOWN International Society for Cellular Therapy
Oct 5, 2007·Nature·Antoine E KarnoubRobert A Weinberg
May 14, 2009·Cancer Research·Michael R LoebingerSam M Janes
Mar 24, 2012·Cancer Cell·Douglas Hanahan, Lisa M Coussens
Sep 16, 2014·International Journal of Cancer. Journal International Du Cancer·Jacques FerlayFreddie Bray
May 15, 2015·The New England Journal of Medicine·Robert J MayerUNKNOWN RECOURSE Study Group
Dec 24, 2015·International Journal of Molecular Sciences·Ki-Jong RheeYoung Woo Eom
Jul 7, 2016·Annals of Oncology : Official Journal of the European Society for Medical Oncology·E Van CutsemD Arnold
Apr 5, 2017·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Gulam Abbas ManjiPaul Oberstein
Jul 14, 2017·Journal of Cellular Physiology·Rana Moradian TehraniHamed Mirzaei
Jul 30, 2017·Cancers·Huey-Jen Lin, Jiayuh Lin
Oct 11, 2017·Nature Reviews. Clinical Oncology·Sumera RizviGregory J Gores
Apr 5, 2018·Frontiers in Pharmacology·Daria S ChulpanovaValeriya V Solovyeva
Apr 25, 2018·Disease Models & Mechanisms·Valerie S LeBleu, Raghu Kalluri

❮ Previous
Next ❯

Citations

Sep 26, 2020·Frontiers in Cell and Developmental Biology·Patricia Kauanna Fonseca DamascenoMilena Botelho Pereira Soares
Jul 3, 2020·Nature Reviews. Drug Discovery·Erin A Kimbrel, Robert Lanza
Oct 18, 2020·Molecular Therapy : the Journal of the American Society of Gene Therapy·Mariella TutterChristine Spitzweg
Feb 14, 2021·Journal of Hematology & Oncology·Tian ZhouPeilong Lai
Nov 19, 2020·Stem Cell Reviews and Reports·Jiayi ZhangYaming Wei
May 1, 2021·International Journal of Molecular Sciences·Karim RihawiMatteo Renzulli
Apr 20, 2021·Frontiers in Cell and Developmental Biology·Rebecca M HarmanGerlinde R Van de Walle
May 29, 2021·Frontiers in Oncology·Yuyi LiXinliang Lu
Jun 8, 2021·Frontiers in Cell and Developmental Biology·Yanghong NiXuelei Ma
Jun 18, 2021·Stem Cell Reviews and Reports·Alison R Mercer-SmithShawn D Hingtgen
Aug 6, 2021·Stem Cells International·Jintao YuanFei Mao
Jul 28, 2021·Expert Opinion on Drug Delivery·Yukiya TakayamaMakiya Nishikawa
Nov 19, 2021·Journal of Hematology & Oncology·Tianxia LanXiawei Wei

❮ Previous
Next ❯

Related Concepts

Related Feeds

Allogenic & Autologous Therapies

Allogenic therapies are generated in large batches from unrelated donor tissues such as bone marrow. In contrast, autologous therapies are manufactures as a single lot from the patient being treated. Here is the latest research on allogenic and autologous therapies.