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 range
18 Years
Sex
ALL
See this in plain English?
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.
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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