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Cx611-0204 SEPCELL Study

NCT03158727 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2022-04-06

Study results available
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Summary

The purpose of this randomised, multicentre, double-blind, placebo-controlled, phase Ib/IIa study is to assess the safety, tolerability and efficacy of eASCs (Cx611) administered intravenously as adjunctive therapy, therefore in addition to standard of care (SoC) therapy, to patients with severe community-acquired bacterial pneumonia (sCABP).

The completion of this study will contribute to the basic knowledge on stem cells and their mode-of-action, and has a large translational character, i.e. to document the safety and explore the efficacy of Cx611 in patients with sCABP.

Conditions

  • Bacterial Pneumonia

Interventions

BIOLOGICAL

Cx611

Two intravenous infusions, one on day 1 and another one on day 3.

OTHER

Placebo

Two intravenous infusions, one on day 1 and another one on day 3.

Sponsors & Collaborators

  • European Commission

    collaborator OTHER

  • Centre Hospital Regional Universitaire de Limoges

    collaborator OTHER

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Hospital San Carlos, Madrid

    collaborator OTHER

  • Tigenix S.A.U.

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-30
Primary Completion
2020-07-07
Completion
2020-07-07

Countries

  • Belgium
  • France
  • Italy
  • Lithuania
  • Norway
  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03158727 on ClinicalTrials.gov