Xerostomy Regenerating Glands with Cultured Mesenchymal Stem Cells

Phase II clinical trial to evaluate the effect and safety of MSV* in xerostomia

ClinicalTrials.gov Identifier: NCT03743155
Nº EudraCT: 2018-001720-19

Objectives

Clinical trial to evaluate the effect and safety of treatment with MSV in patients with radiation-induced xerostomia.

Methodology

Phase II, uncontrolled, open-label, prospective and unicentric clinical trial. 10 adult patients with xerostomy (grade 1-3) treated with bilateral radiotherapy of the neck.

The efficacy and safety variables include:
– Changes in the characteristics of xerostomia and degree of discomfort, evaluated through HCP and patient questionnaires
– Volume of submaxillary saliva with and without stimulation by sialometry (SL)
– Changes in volume, vascularization and fibrosis of the submaxillary glands using magnetic resonance imaging (MRI)
– Measurement of submaxillary gland functionalism changes based on gammagraphy (GF)


STUDY DESCRIPTION

Unicentric study
Development phase: I-II
Status: ongoing
PEI: 10-134
Nº Eudra-CT: 2018-001720-19
Code: XRS-ITRT-2018
ClinicalTrials.gov: NCT01183728
Sponsor: ITRT
CEIm: Grupo Hospitalario Quirónsalud-Barcelona
Control: Spanish Medicine Agency (AEMPS)
CRO: ADKNOMA
Investigators: J Coromina, J Cameira, R Soler Rich, L Orozco, X Peirau, A Sánchez, J García Sancho, M Alberca, V García, J Ramón García, X Alomar, M Feliciani, A Planas
Participating entities: Centro Médico Teknon, IBGM (Valladolid University and CSIC), Departamento de Resonancia Magnética de Clínica Creu Blanca, Departamento Gammagrafia CETIR-ASCIRES.

*MSV= autologous bone marrow mesenchymal progenitor cells expanded with IBGM GMP procedures