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Trial record 8 of 339 for:    "Eye Diseases, Hereditary" OR "Peters plus syndrome"

Autologous Adipose-Derived Adult Stem Cell Transplantation for Corneal Diseases (A-ADAS-CT-CD)

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ClinicalTrials.gov Identifier: NCT02932852
Recruitment Status : Unknown
Verified October 2016 by Vissum, Instituto Oftalmológico de Alicante.
Recruitment status was:  Recruiting
First Posted : October 13, 2016
Last Update Posted : October 13, 2016
Sponsor:
Collaborators:
Reviva Pharmaceuticals
Hospital Universitario La Paz
LASER VISION CENTER IN LIBANON
OPTICA GENERAL IN LIBANON
Information provided by (Responsible Party):
Vissum, Instituto Oftalmológico de Alicante

Brief Summary:
Transplantation of cellularized human cornea impregnated and populated by mesenchymal stem cells derived from the patient's adipose tissue. The purpose of the study is to assess the safety, tolerability, and preliminary efficacy of transplantation of a single dose of autologous mesenchymal adipose tissue derived adult stem cells (ADAS) cellularized into laminas for subjects with corneal defects. 3 groups will be included in the study: (1) transplantation of ADAS alone without scaffold, (2) transplantation of scaffold (human corneal decellularized lamina) without ADAS, and (3) transplantation of ADAS cellularized on scaffold (the human corneal decellularized lamina)

Condition or disease Intervention/treatment Phase
Hereditary Corneal Dystrophy Keratoconus Procedure: Lipoaspiration Procedure: Transplantation Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Adipose-Derived Adult Stem Cell Transplantation for Corneal Diseases
Study Start Date : November 2015
Estimated Primary Completion Date : April 2017


Arm Intervention/treatment
Active Comparator: GROUP I
lipoaspiration and transplantation of ADAS alone without scaffold
Procedure: Lipoaspiration
The patient will have a liposuction surgery from which the autologous ADAS cell to transplant in the cornea will be obtained.

Procedure: Transplantation
The ophthalmologist will carry out the transplantation of the ADAS cells with or without scaffold in the intrastromal cornea of the patient

Active Comparator: GROUP II
Lipoaspiration and transplantation of scaffold (human corneal decellularized lamina) without ADAS
Procedure: Lipoaspiration
The patient will have a liposuction surgery from which the autologous ADAS cell to transplant in the cornea will be obtained.

Procedure: Transplantation
The ophthalmologist will carry out the transplantation of the ADAS cells with or without scaffold in the intrastromal cornea of the patient

Active Comparator: GROUP III
Lipoaspiration and transplantation of ADAS cellularized on scaffold (the human corneal decellularized lamina)
Procedure: Lipoaspiration
The patient will have a liposuction surgery from which the autologous ADAS cell to transplant in the cornea will be obtained.

Procedure: Transplantation
The ophthalmologist will carry out the transplantation of the ADAS cells with or without scaffold in the intrastromal cornea of the patient




Primary Outcome Measures :
  1. Vision recovery (Corrected Distance Visual Acuity) [ Time Frame: post operative visit at 1 day, 1 month, 3 months and 6 months ]
    The Best Corrected Visual Acuity will be measured in each postoperative visit to control any important decrease relative to the surgery


Secondary Outcome Measures :
  1. Corneal Thickness [ Time Frame: post operative visit at 1 day, 1 month, 3 months and 6 months ]
    At each post operative visit a measurement of corneal pachymetry of the transplanted cornea will be carried out to detect any abnormal evolution

  2. Topopgraphy [ Time Frame: post operative visit at 1 month, 3 months and 6 months ]
    At each post operative visit a measurement of Anterior surface topography of the transplanted cornea will be carried out to detect any abnormal evolution

  3. Anterior segment Optical Coherence Tomography [ Time Frame: post operative visit at 1 month, 3 months and 6 months ]
    At each post operative visit a measurement anterior segment Optical Coherence Tomography of the transplanted cornea will be carried out to detect any abnormal evolution

  4. Slit Lamp Observation [ Time Frame: post operative visit at 1 day, 1 month, 3 months and 6 months ]
    At each post operative visit, the corneal aspect relative to new tissue will be evaluated by slit lamp observation

  5. refraction measurement [ Time Frame: post operative visit at 1 day, 1 month, 3 months and 6 months ]
    At each post operative visit, the corneal aspect relative to increase in irregular astigmatism will be evaluated by refraction measurement



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients affected by corneal stromas dystrophies of any type, but particularly keratoconus, showing clear evidence at the ophthalmic examination of the presence and clear expression of the disease
  • Age : ≥ 18 years
  • Gender: any
  • Willing to collaborate and to attend to the clinical follow ups for the next five years
  • Patients willing to sign informed consent
  • Able and willing to comply with all study requirements
  • Patients with and no worse than 0.6 for the better vision patients
  • Comprehensive clinical ophthalmological including slit lamp photography of the cornea of either eye
  • Corneal topography map including both anterior and posterior corneal surfaces
  • Specular microscopy
  • Confocal microscopy of the centre of the cornea
  • Absence of anterior segment inflammation
  • Medically suitable to undergo corneal graft surgery with local anesthesia
  • Medically suitable for general anesthesia or waking sedation, if needed
  • Normal serum chemistry and hematology screening tests
  • Negative human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) serology
  • No history of malignancy
  • Complete history & physical examination
  • Negative chest roentgenogram (CXR)
  • Negative urinalysis (U/A)
  • Normal thyroid exam

Exclusion Criteria:

  • - Patients not willing to sign informed consent
  • Defects in corneal transparency with a potential to affect the visual outcome
  • Vision of 0.05 or less
  • Severe corneal deformation
  • Infection
  • Moderate or severe dry eye
  • Chronic ocular surface inflammation of any origin
  • Previous ocular surgery other than cataract
  • Presence of cataract or other media opacity that would influence ocular fundus documentation and adequate ERG and visual field evaluation.
  • Other ophthalmic comorbidity like glaucoma and uveitis
  • Known allergy: example to propacaine, ciprofloxacin, fluorescein , indocyanine green, or others to specify
  • Known coagulation abnormalities
  • Any medical condition likely interferes to cause serious adverse events during the study
  • Presence of active or inactive choroidal neovascularization (CNV) in the eye to be treated
  • History of malignancy
  • History of cognitive impairments or dementia which may impact the patient's ability to participate in the informed consent process and to appropriately complete evaluations
  • Any immunodeficiency
  • Any current immunosuppressive therapy other than intermittent or low dose corticosteroids
  • Renal insufficiency, as defined by creatine level >1.3 mg/dL.
  • Serologic evidence of infection with Hepatitis B, Hepatitis C, or HIV
  • If female, pregnancy or lactation.
  • Any other medical condition, which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromises patient safety, or interferes with the interpretation of the study results.corneal dystrophies of any type, in a stage which either could be prevented in progression (with best corrected visual acuity superior to 0.6) or with indication for keratoplasty (best corrected visual acuity <0.2). The cases should not have defects in corneal transparency which would lead to vision of 0.05 or less or severe corneal optical deformation (in the case of keratoconus).
  • The visual acuity of the eye to receive the transplant will be no better than 20/400
  • The visual acuity of the eye in the better vision cohort to receive the transplant will be no better than 0.1 at the Snellen charts
  • The visual acuity of the eye that is not to receive the transplant will be no better than 0.2 for the worse vision patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932852


Contacts
Contact: Jorge Alio Sanz, MD, PhD +34 902333344 jlalio@vissum.com
Contact: Nehman Makdissy, PhD +96171210250 almakdissy@hotmail.com

Locations
Lebanon
Optica General Recruiting
Saida, Lebanon, 10450
Contact: Mona El Zarif, OD    +9613610200    monazarifaj@hotmail.com   
Contact: ziad abduljawad, OD    +9613337335    zicco66@hotmail.com   
Sponsors and Collaborators
Vissum, Instituto Oftalmológico de Alicante
Reviva Pharmaceuticals
Hospital Universitario La Paz
LASER VISION CENTER IN LIBANON
OPTICA GENERAL IN LIBANON
Investigators
Study Chair: Mona El Zarif, OD Optica General

Publications:
Responsible Party: Vissum, Instituto Oftalmológico de Alicante
ClinicalTrials.gov Identifier: NCT02932852     History of Changes
Other Study ID Numbers: CTP-007/15
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by Vissum, Instituto Oftalmológico de Alicante:
stem cell
mesenchymal
ADASc
transplantation
cornea
corneal defects
keratoconus
scaffold
lamina

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Corneal Dystrophies, Hereditary
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn