Autologous Adipose-Derived Adult Stem Cell Transplantation for Corneal Diseases
A-ADAS-CT-CD
1 other identifier
interventional
12
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
1 active site
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
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 2, 2016
CompletedFirst Posted
Study publicly available on registry
October 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedOctober 13, 2016
October 1, 2016
1.4 years
October 2, 2016
October 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vision recovery (Corrected Distance Visual Acuity)
The Best Corrected Visual Acuity will be measured in each postoperative visit to control any important decrease relative to the surgery
post operative visit at 1 day, 1 month, 3 months and 6 months
Secondary Outcomes (5)
Corneal Thickness
post operative visit at 1 day, 1 month, 3 months and 6 months
Topopgraphy
post operative visit at 1 month, 3 months and 6 months
Anterior segment Optical Coherence Tomography
post operative visit at 1 month, 3 months and 6 months
Slit Lamp Observation
post operative visit at 1 day, 1 month, 3 months and 6 months
refraction measurement
post operative visit at 1 day, 1 month, 3 months and 6 months
Study Arms (3)
GROUP I
ACTIVE COMPARATORlipoaspiration and transplantation of ADAS alone without scaffold
GROUP II
ACTIVE COMPARATORLipoaspiration and transplantation of scaffold (human corneal decellularized lamina) without ADAS
GROUP III
ACTIVE COMPARATORLipoaspiration and transplantation of ADAS cellularized on scaffold (the human corneal decellularized lamina)
Interventions
The patient will have a liposuction surgery from which the autologous ADAS cell to transplant in the cornea will be obtained.
The ophthalmologist will carry out the transplantation of the ADAS cells with or without scaffold in the intrastromal cornea of the patient
Eligibility Criteria
You may qualify if:
- 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
- +6 more criteria
You may not qualify if:
- \- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vissum, Instituto Oftalmológico de Alicantelead
- Reviva Pharmaceuticalscollaborator
- Hospital Universitario La Pazcollaborator
- LASER VISION CENTER IN LIBANONcollaborator
- OPTICA GENERAL IN LIBANONcollaborator
Study Sites (1)
Optica General
Saida, 10450, Lebanon
Related Publications (5)
Alio del Barrio JL, Chiesa M, Garagorri N, Garcia-Urquia N, Fernandez-Delgado J, Bataille L, Rodriguez A, Arnalich-Montiel F, Zarnowski T, Alvarez de Toledo JP, Alio JL, De Miguel MP. Acellular human corneal matrix sheets seeded with human adipose-derived mesenchymal stem cells integrate functionally in an experimental animal model. Exp Eye Res. 2015 Mar;132:91-100. doi: 10.1016/j.exer.2015.01.020. Epub 2015 Jan 24.
PMID: 25625506BACKGROUNDDe Miguel MP, Alio JL, Arnalich-Montiel F, Fuentes-Julian S, de Benito-Llopis L, Amparo F, Bataille L. Cornea and ocular surface treatment. Curr Stem Cell Res Ther. 2010 Jun;5(2):195-204. doi: 10.2174/157488810791268663.
PMID: 19941445BACKGROUNDAlio del Barrio JL, Chiesa M, Gallego Ferrer G, Garagorri N, Briz N, Fernandez-Delgado J, Sancho-Tello Valls M, Botella CC, Garcia-Tunon I, Bataille L, Rodriguez A, Arnalich-Montiel F, Gomez Ribelles JL, Antolinos-Turpin CM, Gomez-Tejedor JA, Alio JL, De Miguel MP. Biointegration of corneal macroporous membranes based on poly(ethyl acrylate) copolymers in an experimental animal model. J Biomed Mater Res A. 2015 Mar;103(3):1106-18. doi: 10.1002/jbm.a.35249. Epub 2014 Jun 18.
PMID: 24910285BACKGROUNDAlio JL. Corneal regeneration: How can we make further progress in corneal surgery with advanced therapies to avoid corneal substitution: ESCRS Binkhorst Medal Lecture 2023. J Cataract Refract Surg. 2025 Nov 1;51(11):1026-1033. doi: 10.1097/j.jcrs.0000000000001745.
PMID: 41126474DERIVEDEl Zarif M, Alio JL, Alio Del Barrio JL, Abdul Jawad K, Palazon-Bru A, Abdul Jawad Z, De Miguel MP, Makdissy N. Corneal Stromal Regeneration Therapy for Advanced Keratoconus: Long-term Outcomes at 3 Years. Cornea. 2021 Jun 1;40(6):741-754. doi: 10.1097/ICO.0000000000002646.
PMID: 33591032DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mona El Zarif, OD
Optica General
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2016
First Posted
October 13, 2016
Study Start
November 1, 2015
Primary Completion
April 1, 2017
Last Updated
October 13, 2016
Record last verified: 2016-10