At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 16 enrolled

Drug / intervention

adipose derived regenerative cells +1 morebiological

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02904824

NCT02904824Phase 2Completed

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Injection Laryngoplasty Using Autologous Fat Enriched With Adipose Derived Regenerative Stem Cells (ADRC) vs Centrifuged Autologous Fat (CAF), for the Functional Reconstruction of the Glottal Gap After Unilateral Vocal Cord Paralysis

Hospital General Universitario Gregorio Marañon·interventional·Posted Sep 19, 2016·Updated Sep 19, 2016

In Brief

A Phase 2 clinical trial evaluating adipose derived regenerative cells and centrifuged autologous fat for Vocal Cord Paralysis, Unilateral. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsVocal Cord Paralysis, Unilateral

CountriesSpain

Collaborators--

Timeline

Phase 2CompletedFinished

20132014201520162017201820192020202120222023202420252026

Enrollment StartJul 2012

Primary CompletionSep 2014

Study CompletionJul 2015

First PostedSep 2016

TodayJul 2026

First PostedSep 19, 2016

Enrollment StartJul 1, 2012

Primary CompletionSep 1, 2014

Study CompletionJul 1, 2015

TodayJul 2, 2026

Enrollment to primary: 2.2 yearsPosted 9.8 years ago

Interventions

adipose derived regenerative cellsbiological

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.

centrifuged autologous fatbiological

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.