Manufacturing and use of human placenta-derived mesenchymal stromal cells for phase i clinical trials: establishment and evaluation of a protocol

Ilic, Nina and Atkinson, Kerry (2014) Manufacturing and use of human placenta-derived mesenchymal stromal cells for phase i clinical trials: establishment and evaluation of a protocol. Vojnosanitetski Pregled, 71 7: 651-659. doi:10.2298/VSP130410050I


Author Ilic, Nina
Atkinson, Kerry
Title Manufacturing and use of human placenta-derived mesenchymal stromal cells for phase i clinical trials: establishment and evaluation of a protocol
Journal name Vojnosanitetski Pregled   Check publisher's open access policy
ISSN 0042-8450
Publication date 2014
Year available 2014
Sub-type Article (original research)
DOI 10.2298/VSP130410050I
Open Access Status DOI
Volume 71
Issue 7
Start page 651
End page 659
Total pages 9
Place of publication Belgrade, Serbia
Publisher Savezno Ministarstvo Odbrane * Sanitetska Uprava
Collection year 2015
Language eng
Abstract Background/Aim. Mesenchymal stromal cells (MSCs) have been utilised in many clinical trials as an experimental treatment in numerous clinical settings. Bone marrow remains the traditional source tissue for MSCs but is relatively hard to access in large volumes. Alternatively, MSCs may be derived from other tissues including the placenta and adipose tissue. In an initial study no obvious differences in parameters such as cell surface phenotype, chemokine receptor display, mesodermal differentiation capacity or immunosuppressive ability, were detected when we compared human marrow derived- MSCs to human placenta-derived MSCs. The aim of this study was to establish and evaluate a protocol and related processes for preparation placenta-derived MSCs for early phase clinical trials. Methods. A full-term placenta was taken after delivery of the baby as a source of MSCs. Isolation, seeding, incubation, cryopreservation of human placentaderived MSCs and used production release criteria were in accordance with the complex regulatory requirements applicable to Code of Good Manufacturing Practice manufacturing of ex vivo expanded cells. Results. We established and evaluated instructions for MSCs preparation protocol and gave an overview of the three clinical areas application. In the first trial, MSCs were co-transplanted iv to patient receiving an allogeneic cord blood transplant as therapy for treatmentrefractory acute myeloid leukemia. In the second trial, MSCs were administered iv in the treatment of idiopathic pulmonary fibrosis and without serious adverse effects. In the third trial, MSCs were injected directly into the site of tendon damage using ultrasound guidance in the treatment of chronic refractory tendinopathy. Conclusion. Clinical trials using both allogeneic and autologous cells demonstrated MSCs to be safe. A described protocol for human placenta-derived MSCs is appropriate for use in a clinical setting, relatively inexpensive and can be relatively easily adjusted to a different set of regulatory requirements, as applicable to early phase clinical trials.
Keyword Stromal cells
Therapeutics
Clinical protocols
Clinical medicine
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: UQ Centre for Clinical Research Publications
Official 2015 Collection
 
Versions
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 3 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 6 times in Scopus Article | Citations
Google Scholar Search Google Scholar
Created: Tue, 22 Jul 2014, 03:03:28 EST by System User on behalf of UQ Centre for Clinical Research