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Injection Laryngoplasty Using Autologous Fat Enriched With Adipose Derived Regenerative Stem Cells (ADRC)

NCT02904824 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-09-19

No results posted yet for this study

Summary

This is the first Development Safety Update Report prepared for Phase I-IIA Clinical Trial- FIBHGM-ECNC007-2010 (PHASE I / IIA CLINICAL TRIAL, UNICENTRIC, RANDOMIZED, CONTROLLED, TWO PARALLEL-GROUPS, TO EVALUATE THE SAFETY OF A NEW THERAPY WITH STEM CELLS DERIVED FROM ADIPOSE TISSUE FOR GLOTTAL GAP(GG) IN THE UNILATERAL PARALYSIS OF THE VOCAL CORD(VC) ) in the International Conference on Harmonization (ICH). Patients are randomized to receive one of the following therapeutic strategies:

Group A: Autologous Fat processed by centrifugation to fill a paralyzed vocal cord. Group B: Autologous Fat enriched with stem cells from adipose tissue to treat vocal cord paralysis.

Active control: Autologous fat tissue processed by centrifugation. Route of administration: Injection into a paralyzed vocal cord.

Experimental drug: Stem cells from autologous adipose tissue in which autologous tissue is enriched or in suspension to fill the paralyzed vocal cord. The aim is to induce the overexpression and production of microvessels at local level. Route of administration: injection into the thickness of a paralyzed vocal cord.

Conditions

  • Vocal Cord Paralysis, Unilateral

Interventions

BIOLOGICAL

adipose derived regenerative cells

Stem cells from autologous adipose tissue in which autologous tissue is enriched or in suspension to fill the paralyzed vocal cord. The aim is to induce the overexpression and production of microvessels at local level. Route of administration: injection into the thickness of a paralyzed vocal cord.

BIOLOGICAL

centrifuged autologous fat

centrifuged adipose tissue which is autologous tissue is used to fill the paralyzed vocal cord. The aim is to increase the volume of the vocal fold, to reduce the glottal gap.This effect is temporary. Route of administration: injection into the thickness of a paralyzed vocal cord.

Sponsors & Collaborators

  • Hospital General Universitario Gregorio Marañon

    lead OTHER

Principal Investigators

  • Jose M Lasso, MD, PhD · Hospital General Universitario Gregorio Marañón

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-09-30
Completion
2015-07-31

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 NCT02904824 on ClinicalTrials.gov