A Phase 1/2 interventional study of adipose derived regenerative cells and centrifuged autologous fat in Vocal Cord Paralysis, Unilateral, sponsored by Hospital General Universitario Gregorio Marañon. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-19.
Sponsored by Hospital General Universitario Gregorio Marañon · Phase 1/2, Interventional, and Treatment
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.
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 IN THE UNILATERAL PARALYSIS OF THE VOCAL CORD in the International Conference on Harmonization (ICH) E2F format. This trial contains relevant safety information from the reporting interval of 08 July 2012 to 30 Sep 2014 This phase I / IIA clinical trial has been conducted to evaluate the safety of ADRCs. This new therapy is performed to induce the overexpression and production of microvessels in the paralyzed vocal cord, to permanently increase its volume and thus facilitate the GG closure. In paralysis of VC an increase of glottal gap occurs leading to dysphonia and aspiration of food, foreign bodies...
The creation of these new blood vessels, through the action of stem cells derived from adipose tissue, may produce a greater volume of the paralyzed vocal cord allowing GG closure more easily.
Patients included in this clinical trial require treatment for unilateral vocal cord paralysis. It has been considered regarding the authorised protocol that a glottal GAP requires intracordal injection to increase its volume when the glottal closure·during phonation is insufficient or there is lack of compensation to the contralateral vocal cord.
Patients are randomized to receive one of the following therapeutic strategies:
Group A: Autologous Fat processed by centrifugation to fill a paralyzed vocal cord, using the same.
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 inside 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.
In patients assigned to ADRC group therapy, two surgical interventions are performed on the same day, once randomized, at visit 0 according to the protocol. For the group assigned to the control (autologous adipose tissue), the therapy is performed in a single surgical intervention, once randomized, at visit 0 according to protocol.
The patients who are included will be followed for six months from the implant.
55 studies on the registry are indexed under Vocal Cord Paralysis; 14 are open to participants now.
This study's enrollment of 16 is below the median of 39 across 38 interventional studies indexed under Vocal Cord Paralysis.
Browse Vocal Cord Paralysis studies →Hospital General Universitario Gregorio Marañon is the lead sponsor of 59 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Biological: 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: adipose derived regenerative cells
Biological: Autologous fat tissue processed by centrifugation. Route of administration: Injection inside a paralyzed vocal cord.
Biological: centrifuged autologous fat
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 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.
Incidence of Treatment-Emergent Adverse Events
Adipose derived stem cells injected into the vocal cords are evaluated in order to study the incidence of possible adverse events: Glottal oedema, laryngospasm, granuloma at the vocal cord, anaphylactic shock, induced tumorigenesis are undesirable adverse events.
Time frame: up to 6 months
Assessment of vocal cord volume and gap closure by direct laryngoscopy and Biometphone device to study vocal cord parameters
Direct laryngoscope will evaluate the volume of the paralyzed one and measure the GG. The description of the GG conditions observed in patients before and after the treatment from laryngoscopy inspections prior and 180 days after surgery may show incomplete coaptations of the GG presenting a partial closure pattern or total coaptation. Biomet phone is a device that measures biomechanical characterization of voice. Accurate spectral domain techniques allow the estimation of a set of biomechanical parameters associated to a 2-mass model of the VF from the glottal source spectral density. The modification in voice quality can be expressed numerically using likelihood estimations. In evaluating the improvement in voice quality, the proposed methodology is based on the use of the Log Likelihood Improvement Ratios (LLIR), a metrics founded on alternative hypothesis testing speech evidence matching.
Time frame: up to 6 months
Plan to share: No
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Hospital General Universitario Gregorio Marañon