Autologous mesenchymal stromal cells embedded with Tissucol Duo® for prevention of air leak after anatomical lung resection: results of a prospective phase I/II clinical trial with long-term follow-up

Stem Cell Research & Therapy

Research

Eva M. Villarón¹  Miriam López-Parra²  Fermín Sánchez-Guijo³  Marcelo F. Jiménez⁴  María Teresa Gómez-Hernández⁴ 

[1] Cell Therapy Area & Hematology Department, Salamanca University Hospital, Salamanca, Spain;Network Centre for Regenerative Medicine and Cellular Therapy of Castilla y León, Salamanca, Spain;Cell Therapy Area & Hematology Department, Salamanca University Hospital, Salamanca, Spain;Salamanca Institute of Biomedical Research (IBSAL), Salamanca, Spain;Network Centre for Regenerative Medicine and Cellular Therapy of Castilla y León, Salamanca, Spain;Cell Therapy Area & Hematology Department, Salamanca University Hospital, Salamanca, Spain;Salamanca Institute of Biomedical Research (IBSAL), Salamanca, Spain;University of Salamanca, Salamanca, Spain;Network Centre for Regenerative Medicine and Cellular Therapy of Castilla y León, Salamanca, Spain;Service of Thoracic Surgery, Salamanca University Hospital, 37007, Salamanca, Spain;Salamanca Institute of Biomedical Research (IBSAL), Salamanca, Spain;University of Salamanca, Salamanca, Spain;

关键词: Mesenchymal stem cells;    Mesenchymal stromal cells;    MSCs;    Air leak;    Lung resection;    Pulmonary resection;    Lobectomy;    Cellular therapy;    Advanced therapies medical products: ATMPs;    Tissue Col;   

DOI  :  10.1186/s13287-023-03545-8

 received in 2022-12-14, accepted in 2023-10-25,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundProlonged air leak (PAL) is the most frequent complication after pulmonary resection. Several measures have been described to prevent the occurrence of PAL in high-risk patients, however, the potential role of mesenchymal stem cells (MSCs) applied in the parenchymal suture line to prevent postoperative air leak in this setting has not been fully addressed. ObjectiveTo analyse the feasibility, safety and potential clinical efficacy of the implantation of autologous MSCs embedded in Tissucol Duo® as a prophylactic alternative to prevent postoperative prolonged air leak after pulmonary resection in high-risk patients.Study designPhase I/II single-arm prospective clinical trial.MethodsSix patients with high risk of PAL undergoing elective pulmonary resection were included. Autologous bone marrow-derived MSCs were expanded at our Good Manufacturing Practice (GMP) Facility and implanted (embedded in a Tissucol Duo® carrier) in the parenchymal suture line during pulmonary resection surgery. Patients were monitored in the early postoperative period and evaluated for possible complications or adverse reactions. In addition, all patients were followed-up to 5 years for clinical outcomes.ResultsThe median age of patients included was 66 years (range: 55–70 years), and male/female ratio was 5/1. Autologous MSCs were expanded in five cases, in one case MSCs expansion was insufficient. There were no adverse effects related to cell implantation. Regarding efficacy, median air leak duration was 0 days (range: 0–2 days). The incidence of PAL was nil. Radiologically, only one patient presented pneumothorax in the chest X-ray at discharge. No adverse effects related to the procedure were recorded during the follow-up.ConclusionsThe use of autologous MSCs for prevention of PAL in patients with high risk of PAL is feasible, safe and potentially effective.Trial registration No. EudraCT: 2013-000535-27. Clinicaltrials.gov idenfier: NCT02045745.

【 授权许可】

CC BY   
© The Author(s) 2023