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.
