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Autologous Adipose-Derived Adult Stem Cell Implantation for Corneal Diseases (ADASCs-CT-CD) (ADASCs-CT-CD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05279157
Recruitment Status : Recruiting
First Posted : March 15, 2022
Last Update Posted : April 28, 2022
Sponsor:
Collaborators:
Universidad Miguel Hernandez de Elche
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Vissum, Instituto Oftalmológico de Alicante

Brief Summary:

Cellular therapy of the corneal stroma with implantation of mesenchymal stem cells derived from autologous adipose tissue with or without a carrier (scaffold) composed by decellularized human donor corneal stroma is used in patients with corneal diseases such as corneal dystrophies, and keratoconus.

For this purpose, the study planned to assess the enhancement of visual acuity, pachymetric, and aberrometric parameters with implantation of autologous mesenchymal adipose tissue-derived adult stem cells (ADASCs) alone, 120 µm thickness of decellularized or recellularized laminas with ADASCs. Three groups will be included in the study: (1) Implantation of a single dose of ADASCs alone without scaffold. (2) Implantation of decellularized human corneal lamina without ADASCs. (3) Implantation of the recellularized human corneal lamina with ADASCs.


Condition or disease Intervention/treatment Phase
Ophthalmological Disorder Corneal Dystrophy Treatment Therapy Keratoconus Procedure: Implantation Procedure: Lipoaspiration Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In this study, 15 evaluable patients affected by corneal stromal dystrophies of any type (particularly keratoconus) will be included in 3 different groups. Ten patients will be included in the two experimental groups and five in the control group with cell-free treatment (5 patients per group and a total of 3 groups)
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Patients who agree to participate in the study and sign the informed consent will be randomized to enter one of the three groups in a 1: 1: 1 ratio. For this, a randomization scheme will be used that will be unknown to the patient, the center staff, and the promoter staff who intervene directly in the study.
Primary Purpose: Treatment
Official Title: Implantation of Autologous Mesenchymal Stem Cells of Adipose Origin for the Treatment of Corneal Diseases
Actual Study Start Date : April 19, 2022
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022


Arm Intervention/treatment
Experimental: ADASCs Group
5 patients, who will receive adipose tissue mesenchymal stem cells in a single dose as study treatment
Procedure: Implantation
Procedure: Implantation The ophthalmologist will carry out the implantation of the ADASCs cells with or without scaffold in the intrastromal cornea of the patient
Other Name: corneal implantation

Procedure: Lipoaspiration

Procedure: Lipoaspiration The patient will have a liposuction surgery from which the autologous ADASCs implant in the cornea will be obtained.

Procedure: Implantation The ophthalmologist will carry out the implantation of the ADASCs with or without scaffold in the intrastromal cornea of the patient

Other Name: corneal implantation

Experimental: Acellular laminas group
5 patients, who will receive decellularized corneal laminas as treatment medication
Procedure: Implantation
Procedure: Implantation The ophthalmologist will carry out the implantation of the ADASCs cells with or without scaffold in the intrastromal cornea of the patient
Other Name: corneal implantation

Experimental: ADASCs recellularized laminas group
5 patients, who will receive adipose tissue mesenchymal cells combined with decellularized corneal laminas as study treatment in a single intervention
Procedure: Implantation
Procedure: Implantation The ophthalmologist will carry out the implantation of the ADASCs cells with or without scaffold in the intrastromal cornea of the patient
Other Name: corneal implantation

Procedure: Lipoaspiration

Procedure: Lipoaspiration The patient will have a liposuction surgery from which the autologous ADASCs implant in the cornea will be obtained.

Procedure: Implantation The ophthalmologist will carry out the implantation of the ADASCs with or without scaffold in the intrastromal cornea of the patient

Other Name: corneal implantation




Primary Outcome Measures :
  1. Improvement in best-corrected distance visual acuity (BCDVA). [ Time Frame: at 12 months ]
    Best-corrected visual acuity (BCDVA) will be studied in Snellen charts by Logmar and the corresponding equivalent in decimal scale.


Secondary Outcome Measures :
  1. Increase in corneal thickness. [ Time Frame: at 12 months ]
    Corneal thickness will be evaluated by ultrasonic and optical pachymetry (Scheimpflug corneal topography).

  2. Refractive changes [ Time Frame: at 12 months ]
    Refraction will be studied by refractive subjection performed by a certified good clinical practice technician.

  3. Improvement in anterior corneal surface regularity [ Time Frame: at 12 months ]
    Anterior corneal surface regularity will be evaluated by corneal topography map and analysed by the changes in the Zernike polynomials (third order and fourth order spherical aberration).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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 suitable to undergo corneal graft surgery under local anesthesia, from a medical point of view.
  • Pre-surgical analysis of serum biochemistry and normal hematology.
  • Serology for Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), and Hepatitis C (HCV) negative.
  • No history of malignancy.
  • Normal chest x-ray (Rx).
  • Normal urinalysis.
  • Normal thyroid exam

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 to levels of 0.1 or less.
  • Distance corrected vision 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.
  • Previous eye surgery other than cataract.
  • Presence of cataract or other severe opacity of the transparent media of the eye that could prevent adequate examination of the fundus.
  • Other ophthalmic comorbidity such as glaucoma or uveitis or any that requires the chronic use of topical ocular medication.
  • Known and severe coagulation abnormalities.
  • Any medical condition that may interfere with 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-dose corticosteroids.
  • Renal insufficiency, defined by creatine value> 1.3 mg / dL.
  • Serological evidence of hepatitis B, hepatitis C, or HIV infection.
  • Pregnant or lactating woman.
  • Corrected visual acuity in the eye contralateral to the experimental eye less than 20/40 (0.5)

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): NCT05279157


Locations
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Spain
Jorge L. Alio Recruiting
Alicante, Spain, 03016
Contact: Jorge L Alio, MD, PhD    +34 670333344    jlalio@vissum.com   
Contact: Jorge Alio del Barrio, MD, PhD    +34 659240278    jorgealiodelbarrio@vissum.com   
Principal Investigator: JORGE L ALIÓ, MD, PhD         
Sub-Investigator: RAFAEL I BARRAQUER, MD, PhD         
Sub-Investigator: JORGE L ALIO DEL BARRIO, MD, PhD         
Sub-Investigator: DAVID MINGO, MD, PhD         
Sub-Investigator: GEMA BOLIVAR, MD, PhD         
Sub-Investigator: ANGEL R GUTIERREZ, MD, PhD         
Sub-Investigator: FRANCISCO ARNALICH, MD, PhD         
Sub-Investigator: MARIA DE MIGUEL, PhD         
Sponsors and Collaborators
Vissum, Instituto Oftalmológico de Alicante
Universidad Miguel Hernandez de Elche
Instituto de Salud Carlos III
Investigators
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Principal Investigator: Jorge L Alio, MD, PhD Universidad Miguel Hernandez, Elche, Spain
Publications of Results:

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Responsible Party: Vissum, Instituto Oftalmológico de Alicante
ClinicalTrials.gov Identifier: NCT05279157    
Other Study ID Numbers: EI17-00523
2018-000523-14 ( EudraCT Number )
First Posted: March 15, 2022    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Vissum, Instituto Oftalmológico de Alicante:
Regenerative medicine
Corneal bioengineering
Stem cell therapy
Keratoconus
Adipose-derived adult stem cells (ADASCs)
Keratocytes
Corneal confocal microscopy
Advanced corneal therapy
Additional relevant MeSH terms:
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Keratoconus
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn