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Safety Study and Preliminary Efficacy of Infusion Haploidentical Mesenchymal Stem Cells Derived From Bone Marrow for Treating Recessive Dystrophic Epidermolysis Bullosa

NCT04153630 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-11-08

No results posted yet for this study

Summary

Phase I / II pilot clinical trial, to evaluate the safety and preliminary efficacy of the systemic infusion of mesenchymal stem cells derived from bone marrow (BM-MSCs) from a haploidentical donor to improve the healing process and / or the mucocutaneous fragility phenotype associated with EBDR.

Conditions

  • Epidermolysis Bullosa Dystrophica, Recessive

Interventions

BIOLOGICAL

mesenchymal stem cells derived from bone marrow (BM-MSCs)

Procedure: Haploidentical MSCs derived from bone marrow administered by intravenous injection with a dose of 2-3x106 cells / Kg

Sponsors & Collaborators

  • Universidad Carlos III Madrid (TERMeG)

    collaborator UNKNOWN

  • St John's Institute of Dermatology Kings College London

    collaborator UNKNOWN

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • DEBRA

    collaborator UNKNOWN

  • CIBER Enfermedades raras

    collaborator UNKNOWN

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2021-03-31
Completion
2021-03-31

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 NCT04153630 on ClinicalTrials.gov