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Cx611-0101, eASCs Intravenous Administration to Refractory Rheumatoid Arthritis Patients

NCT01663116 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2019-04-12

No results posted yet for this study

Summary

Phase Ib/IIa clinical trial of a new medicinal product of the somatic cell therapy class (eASCs). This study is designed as a multicenter, single blind, fixed dose escalation, with three treatment groups, controlled with placebo (randomization 3:1) whose target population are patients with rheumatoid arthritis refractory to at least two biologic.

Conditions

  • Rheumatoid Arthritis Aggravated

Interventions

GENETIC

Stem cells

1. first cohort: 1 million stem cells/kg administered at days 1, 8 and 15 2. second cohort: 2 million stem cells / kg administered at days 1, 8 and 15 3. third cohort: 4 million stem cells / kg administered at days 1, 8 and 15

GENETIC

Placebo

1. first cohort: 20 ml administered at days 1, 8 and 15 2. second cohort: 40 ml administered at days 1, 8 and 15 3. third cohort: 80 ml administered at days 1, 8 and 15

Sponsors & Collaborators

  • Tigenix S.A.U.

    lead INDUSTRY

Principal Investigators

  • José María Alvaro-Gracia, MD, PhD · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Spain

Study Locations

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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 NCT01663116 on ClinicalTrials.gov