AzTrials
AzTrials

Vocal Cord Paralysis, UnilateralPhase 1/2NCT02904824

Injection Laryngoplasty Using Autologous Fat Enriched With Adipose Derived Regenerative Stem Cells (ADRC)

A Phase 1/2 study testing adipose derived regenerative cells and centrifuged autologous fat in people with Vocal Cord Paralysis, Unilateral, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vocal Cord Paralysis, Unilateral
What is being tested?
adipose derived regenerative cells and centrifuged autologous fat
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteSpain
Study dates
Jul 2012to Jul 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
  • Patient needing a surgery in the anatomical area that is going to be operated on for a different reason at the moment of inclusion in the study, or patients in which it is suspected to perform surgeries in the mentioned anatomical area 24 weeks after the implant.
Show all 19Show fewer
  • Alcohol abuse or drugs abuse 6 months before the inclusion.
  • Latent or active HIV infection or viral hepatitis.
  • Patient suffered a major surgery or a major trauma 28 days before enrollment.
  • Patients treated with immune-modulators (including therapy with systemic stem cells) 6 months before the inclusion in the study.
  • Lung or heart disease that is unstable of presents a gravity that suggests to exclude the enrollment in the study.
  • Life expectancy inferior to one year, in relation to comorbidities presenting in the moment of the clinical evaluation.
  • Patients presenting deep venous thrombosis or lung thromboembolism, or patients who presented these diseases 6 months before the inclusion in the study.
  • Patient presenting acquired or congenital immunodeficiencies.
  • Patients presenting hemorrhagic diseases with INR>2,0, without anticoagulant treatment.
  • Patients with any medical or psychiatric disorder that under the point of view of the researchers justifies the exclusion in the trial, because follow-up could be interrupted, because enrolment could be a risk for the patient or because it could be a risk for the global evaluation of the clinical trial.
  • Patients enrolled currently in other clinical trials, or patients that participated in clinical trial 30 days before the inclusion in this study, if the previous one could not interfere in the participation or in the evaluation of the objectives of the present study.
  • Patient who does not wish or cannot follow the procedures indicated in the clinical trial.
  • Patients treated with platelet anti-aggregates or non-steroid anti-inflammatories 15 days before the surgery.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Jose M Lasso

    Madrid, Madrid, 28007

Other trials in Spain

About this study

Official title: 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

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.

Read more

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.

Read the detailed description

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.

Being tested
adipose derived regenerative cells, centrifuged autologous fat
Keywords
adipose tissue, adult stem cells, vocal cord paralysis
Medical subject headings
Vocal Cord Paralysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02904824
Study groupRoleWhat they receive
ADRC, adipose derived regenerative cellsExperimentalBiological: 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.
Receives: Biological: adipose derived regenerative cells
CAF, centrifuged autologous fatActive comparatorBiological: Autologous fat tissue processed by centrifugation. Route of administration: Injection inside a paralyzed vocal cord.
Receives: Biological: centrifuged autologous fat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 6 months

Secondary outcomes (1)

  1. 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.

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2016 (estimated)
  2. Study startJul 2012
  3. Primary completionSep 2014
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02904824
Sponsor's protocol ID
FIBHGM-ECNC007-2010
Status last verified
Sep 2016
First submitted
20 Jul 2016
Last updated
19 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Zhu M, Zhou Z, Chen Y, Schreiber R, Ransom JT, Fraser JK, Hedrick MH, Pinkernell K, Kuo HC. Supplementation of fat grafts with adipose-derived regenerative cells improves long-term graft retention. Ann Plast Surg. 2010 Feb;64(2):222-8. doi: 10.1097/SAP.0b013e31819ae05c.

    PubMed 20098110

  • Perez-Cano R, Vranckx JJ, Lasso JM, Calabrese C, Merck B, Milstein AM, Sassoon E, Delay E, Weiler-Mithoff EM. Prospective trial of adipose-derived regenerative cell (ADRC)-enriched fat grafting for partial mastectomy defects: the RESTORE-2 trial. Eur J Surg Oncol. 2012 May;38(5):382-9. doi: 10.1016/j.ejso.2012.02.178. Epub 2012 Mar 15.

    PubMed 22425137

  • Rosen CA, Lee AS, Osborne J, Zullo T, Murry T. Development and validation of the voice handicap index-10. Laryngoscope. 2004 Sep;114(9):1549-56. doi: 10.1097/00005537-200409000-00009.

    PubMed 15475780

  • Gómez P, Fernández R, Rodellar V, Nieto V, Álvarez A, Mazaira LM, Martínez R., Godino JI. Glottal Source Biometrical Signature for Voice Pathology Detection, Speech Communication; 51 2009, pp 759-781.

  • Cantarella G, Mazzola RF, Domenichini E, Arnone F, Maraschi B. Vocal fold augmentation by autologous fat injection with lipostructure procedure. Otolaryngol Head Neck Surg. 2005 Feb;132(2):239-43. doi: 10.1016/j.otohns.2004.09.022.

    PubMed 15692533

  • Lasso JM, Poletti D, Scola B, Gomez-Vilda P, Garcia-Martin AI, Fernandez-Santos ME. Injection Laryngoplasty Using Autologous Fat Enriched with Adipose-Derived Regenerative Stem Cells: A Safe Therapeutic Option for the Functional Reconstruction of the Glottal Gap after Unilateral Vocal Fold Paralysis. Stem Cells Int. 2018 Apr 15;2018:8917913. doi: 10.1155/2018/8917913. eCollection 2018.

    PubMed 29760737

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing adipose derived regenerative cells and centrifuged autologous fat in people with Vocal Cord Paralysis, Unilateral, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02904824, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in