Corneal Diseases MedDRA version: 20.0 Level: PT Classification code 10023353 Term: Keratoconus System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: CÉLULAS MESENQUIMALES TRONCALES AUTÓLOGAS DE TEJIDO ADIPOSO EXPANDIDAS QUIESCENTES
Product Code: ADASCq
Pharmaceutical Form: Implant
INN or Proposed INN: CÉLULAS MESENQUIMALES TRONCALES
Sponsors
Universidad Miguel Hernandez
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients affected by corneal stromal dystrophies of any type, but particularly keratoconus, showing clear evidence in the ophthalmic examination of the presence and clear expression of the disease and loss of vision as a result of it. • Age: = 18-60 years. • Patients with best corrected visual acuity less than 0.6. • Absence of chronic or recurrent inflammation in the anterior segment and on the ocular surface. • Patient able to undergo corneal graft surgery with local anesthesia, from the medical point of view. • Normal Pre-surgical analyses of serum biochemistry and hematology. • Negative serology for Human Immunodeficiency Virus (HIV), hepatitis B (HBV), and hepatitis C (HCV). • No history of malignant disease. • Normal chest X-ray (Rx). • Normal urine analysis. • Normal thyroid test. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Dense and extensive corneal stromal scars with severe involvement of the visual axis and located in the pupillary area, causing a decrease in the best corrected vision at levels of 0.1 or less. • Distant vision corrected with glasses of 0.7 or greater. • Extreme corneal thinning with risk of perforation. • Infection. • Previous corneal surgeries. • Moderate or severe dry eye. • Moderate or severe chronic inflammatory pathology of the ocular surface. • Prior ocular surgery other than cataract. • Presence of a cataract or other severe opacity of the transparent media of the eye that could impede the proper examination of the fundus. • Other ophthalmic comorbidity such as glaucoma or uveitis or any that requires the chronic use of ocular topical medication. • Known and severe coagulation abnormalities. • Any medical condition that may interfere causing serious adverse effects during the study. • Presence of active or inactive corneal neovascularization (CNV) in the eye to be treated • Any immunodeficiency or systemic autoimmune disease. • Any current or intermittent immunosuppressive therapy or low doses of corticosteroids. • Renal insufficiency, defined by creatine value >1.3 mg / dL. • Serological evidence of infection due to hepatitis B, hepatitis C or HIV. • Pregnant or lactating woman. • Correct visual acuity in the eye contralateral to the experimental smaller than 20/40 (0.5).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the clinical safety and feasibility of regenerative corneal stromal treatment with autologous mesenchymal stem cells derived from subcutaneous adipose tissue (ADASCs) administered in corneal stroma in patients with corneal dystrophy with structural corneal weakening and consecutive loss of vision, within the framework of a phase I-IIa clinical trial.;Secondary Objective: • To demonstrate the increase of the corneal thickness after the implantation of ADASCs and/or decellularized corneal sheet. • To demonstrate that there is a biological activation of the corneal stroma after the implantation of ADASCs and/or decellularized corneal sheet. • To evaluate the biomechanical characteristics of the eye operated after treatment with the cellular implant (ADASCs) and/or decellularized corneal sheet. • Investigate the changes that occur in the corneal refraction of these patients in topographic and aberrometric terms. • Demonstrate that there is an increase in vision and visual acuity of the patients treated in this way in relation to the use of the cellular implant used.;Primary end point(s): Uncorrected visual acuity and best corrected distance visual acuity: These visual acuities will be evaluated in each post-operative visit in order to quantify the recovery of vision over time. When appropriate, the visual acuity associated with rigid gas permeable contact lens will also be evaluated.;Timepoint(s) of evaluation of this end point: Screening visit, day 1, month 1, month 3, month 6, and month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Refraction • Biomicroscopic integration • High resolution Corneal Topography and Corneal Aberrometry • Corneal thickness • Optical coherence tomography of the anterior segment • Total ocular Aberrometry • Corneal biomechanics • Confocal microscopy;Timepoint(s) of evaluation of this end point: Screening visit, day 1, month 1, month 3, month 6, and month 12 | — |
Countries
Spain
Contacts
Public ContactCarolina Martín Bravo
CABYC S.L.
Outcome results
None listed