Injection Laryngoplasty Using Autologous Fat Enriched With Adipose Derived Regenerative Stem Cell… (NCT02904824) | Clinical Trial Compass
CompletedPhase 1/2
Injection Laryngoplasty Using Autologous Fat Enriched With Adipose Derived Regenerative Stem Cells (ADRC)
Spain16 participantsStarted 2012-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* VC paralysis in paramedian position.
* Patients without previous compensation of the healthy contralateral VF.
* Males and females 18-years old or older.
* Women presenting the possibility of being pregnant must present a negative test of current pregnancy before the inclusion in the clinical trial (it must be certified at the minus 2 medical visit). It can be done by a blood test or a urinary test.
* The paralyzed VC should not be affected by granulomas, tumors o macroscopic objectable lesions by conventional laryngoscopy.
* The clinical situation of the patient must be ASA I or II following the parameters of the American Society of Anesthesiologists.
* There should not be any circumstance that could not afford the patient to follow the procedures of the clinical trial at least 6 months from the operation day.
* The patient must sign and confirm a specific informed acceptance to participate in the trial
Exclusion Criteria:
* Patients affected by kidney insufficiency, presenting a seric creatinine higher than 2.5 mg/dl.
* Medical history of allergy to proteins, or other allergies that could lead to a safety problem if the patient joins the present clinical trial.
* Acute infectious disease at the moment of enrollment.
* Chronic infectious disease affecting directly or indirectly the anatomical area that is going to be operated (it includes tuberculosis, brucellosis, chronic candidiasis and cutaneous chronic ulcers).
* Pregnancy or lactating patient.
*…
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events
Timeframe: up to 6 months
Trial details
NCT IDNCT02904824
SponsorHospital General Universitario Gregorio Marañon