NCT02904824

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

Enrollment Period

2.2 years

First QC Date

July 20, 2016

Last Update Submit

September 13, 2016

Conditions

Vocal Cord Paralysis, Unilateral

Keywords

adipose tissueadult stem cellsvocal cord paralysis

Outcome Measures

Primary Outcomes (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.

    up to 6 months

Secondary Outcomes (1)

  • Assessment of vocal cord volume and gap closure by direct laryngoscopy and Biometphone device to study vocal cord parameters

    up to 6 months

Study Arms (2)

ADRC, adipose derived regenerative cells

EXPERIMENTAL

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

CAF, centrifuged autologous fat

ACTIVE COMPARATOR

Biological: Autologous fat tissue processed by centrifugation. Route of administration: Injection inside a paralyzed vocal cord.

Biological: centrifuged autologous fat

Interventions

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.

ADRC, adipose derived regenerative cells
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.

CAF, centrifuged autologous fat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • VC paralysis in paramedian position.
  • Patients without previous compensation of the healthy contralateral VF.
  • Males and females 18-years old or older.
  • 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

You may not qualify if:

  • 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.
  • Latent or active HIV infection or viral hepatitis.
  • Patient suffered a major surgery or a major trauma 28 days before enrollment.
  • 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.
  • Patient presenting acquired or congenital immunodeficiencies.
  • Patients presenting hemorrhagic diseases with INR\>2,0, without anticoagulant treatment.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jose M Lasso

Madrid, Madrid, 28007, Spain

Location

Related Publications (6)

  • 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.

    PMID: 20098110BACKGROUND

  • 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.

    PMID: 22425137BACKGROUND

  • 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.

    PMID: 15475780BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 15692533BACKGROUND

  • 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.

    PMID: 29760737DERIVED

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVagus Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jose M Lasso, MD, PhD

    Hospital General Universitario Gregorio Marañón

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2016

First Posted

September 19, 2016

Study Start

July 1, 2012

Primary Completion

September 1, 2014

Study Completion

July 1, 2015

Last Updated

September 19, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Clinical Study Report Access

Locations

ES(1)