Autologous Adipose-Derived Adult Stem Cell Transplantation for Corneal Diseases

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2016
• Main ID: NCT02932852
• Date of registration: 02/10/2016
• Prospective Registration: No
• Primary sponsor: Vissum, Instituto Oftalmológico de Alicante
• Public title: Autologous Adipose-Derived Adult Stem Cell Transplantation for Corneal Diseases A-ADAS-CT-CD
• Scientific title: Autologous Adipose-Derived Adult Stem Cell Transplantation for Corneal Diseases
• Date of first enrolment: November 2015
• Target sample size: 12
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02932852
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 0

Countries of recruitment

Lebanon

Contacts

• Name: Jorge Alio Sanz, MD, PhD

• Name: Mona El Zarif, OD
• Affiliation: Optica General

• Name: Mona El Zarif, OD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Keratoconus

Hereditary Corneal Dystrophy

Intervention(s)

Procedure: Transplantation

Procedure: Lipoaspiration

Primary Outcome(s)

Vision recovery (Corrected Distance Visual Acuity) [Time Frame: post operative visit at 1 day, 1 month, 3 months and 6 months]

Secondary Outcome(s)

Corneal Thickness [Time Frame: post operative visit at 1 day, 1 month, 3 months and 6 months]

refraction measurement [Time Frame: post operative visit at 1 day, 1 month, 3 months and 6 months]

Topopgraphy [Time Frame: post operative visit at 1 month, 3 months and 6 months]

Slit Lamp Observation [Time Frame: post operative visit at 1 day, 1 month, 3 months and 6 months]

Anterior segment Optical Coherence Tomography [Time Frame: post operative visit at 1 month, 3 months and 6 months]

Secondary ID(s)

CTP-007/15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospital Universitario La Paz

Reviva Pharmaceuticals

LASER VISION CENTER IN LIBANON

OPTICA GENERAL IN LIBANON