Autologous Adipose-Derived Adult Stem Cell Transplantation for Corneal Diseases

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Brief Title

Autologous Adipose-Derived Adult Stem Cell Transplantation for Corneal Diseases

Official Title

Autologous Adipose-Derived Adult Stem Cell Transplantation for Corneal Diseases

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)
    

Detailed Description

      Different types of stem cells have been used in various ways in several research projects in
      order to find the optimal procedure to regenerate the human corneal stroma. It included
      several approaches which can be classified as intrastromal implantation of stem cells (1)
      alone, (2) together with a biodegradable scaffold, (3) with a non-biodegradable scaffold, or
      (4) with a decellularized corneal stromal scaffold. In fact, the complex structure of the
      corneal stroma has not been yet replicated, and there are well known drawbacks to the use of
      synthetic scaffold-based designs. Recently, several corneal decellularization techniques have
      been described, which provide an acellular corneal extracellular matrix (ECM). These
      scaffolds have gained attention in the last few years as they provide a more natural
      environment for the growth and differentiation of cells when compared with synthetic
      scaffolds. In addition, components of the ECM are generally conserved among species and are
      tolerated well even by xenogeneic recipients. Keratocytes are essential for remodeling the
      corneal stroma and for normal epithelial physiology. This highlights the importance of
      transplanting a cellular substitute together with the structural support (acellular ECM) to
      undertake these critical functions in corneal homeostasis. To the best of the investigators
      knowledge, all attempts to repopulate decellularized corneal scaffolds have used corneal
      cells, but these cells have major drawbacks that preclude their autologous use in clinical
      practice (damage of the donor tissue, lack of cells and inefficient cell subcultures), thus
      the efforts to find an extraocular source of autologous cells. A recent study by the
      investigators has shown a perfect biointegration of human decellularized corneal stromal
      sheets (100µm thickness) with and without h-ADASC colonization inside the rabbit cornea in
      vivo, without observing any rejection response despite the graft being xenogeneic. The
      investigators also demonstrated the differentiation of h-ADASCs into functional keratocytes
      inside these implants in vivo, which then achieved their proper biofunctionalization.
      According to the investigator's opinion the transplant of stem cells together with
      decellularized corneal ECM would be the best technique to effectively restore the thickness
      of a diseased human cornea, like in keratoconus. Through this technique, and using
      extraocular mesenchymal stem cells from patients, it is possible to transform allergenic
      grafts into functional autologous grafts, theoretically avoiding the risk of rejection.

      The process flow is defined as following: (1) the file study: which start by receiving the
      file of the patient, the file will be forwarded to appointed physicians coordinators for
      review and submission of medical report, then the medical report will be evaluated within the
      cell therapy committee and the patient will be asked for clinical examination, and after
      consultation a reply to the patient with medical decision will follow with an approval or not
      to be recruited and if yes, a brief report about the procedure will be submitted and
      explained in details to the patient, a consent form must be signed if the patient agree to be
      included in the study, (2) the patient admission: which may start by completion of the
      procedure forms and doing the pre-op evaluation (initial work up defined as a clinical and
      biological assessment upon C.A.S which may include unaided and best spectacle corrected
      visual acuity, refraction, slit lamp examination, intraocular pressure, fundoscopy, corneal
      topography, aberrometry, endothelial cell count (specular microscopy) as well as blood tests)
      by an ophthalmologist, followed by lipoaspiration of the subcutaneous adipose tissue to be
      performed by a plastic surgeon, then sample processing at a cGMP facility for isolation and
      characterization of the stromal vascular fraction enriched with ADAS as well as laminas
      preparing (the quality control assessment will be realized before and after all the steps of
      the procedure starting from the ADAS collection to transplantation including cell culture,
      cell quiescence, decellularization of human corneal lamina, recellularization of the laminas
      with ADAS, and transplantation; the assessment will include cell viability, cell number, cell
      apoptosis, immunophenotyping, infection, inflammation by analyzing the secreted cytokines
      from ADAS, lamina cutting, lamina thickness, immunostaining, confocal microscopy, etc.); (3)
      the delivery (transplantation) which starts by a peribulbar or retrobulbar anesthesia where
      the patient is placed under operating microscope, followed by a femtosecond laser assisted
      mid-stromal lamellar dissection, then the ADAS or laminas or recellularized laminas will be
      placed within the pocket, and finally closed by a superior incision closure. The patient will
      be putted under antibiotic/steroids for a defined period and followed by the team at 1 week,
      2 weeks, 1 month, 3 months, 6 months and 1 year.

      This protocol of cell therapy will be applied exclusively at Laser Vision (Hazmieh-Lebanon)
      and prepared at Reviva Regenerative Medicine Center in affiliation with VISSUM
      (Alicante-Spain) and Optica General (Saida-Lebanon).

      The patient's recruitment will take place: for the lipoaspiration, processing, preparing the
      celluraized laminas and quality control assessments, at the Middle East Institute of Health
      the Reviva Center (Bsalim-Lebanon) under the regulations of the hospital and the Reviva
      Center; for injection, at Laser vision (Hazmieh-Lebanon); and for follow-up, at Laser vision
      & optica general. All these steps are managed by VISSUM (Prof. J. ALIO).
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Vision recovery (Corrected Distance Visual Acuity)

Secondary Outcome

 Corneal Thickness

Condition

Hereditary Corneal Dystrophy

Intervention

Lipoaspiration

Study Arms / Comparison Groups

 GROUP I
Description:  lipoaspiration and transplantation of ADAS alone without scaffold

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

12

Start Date

November 2015


Primary Completion Date

April 2017

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mona El Zarif, OD, +34 902333344, [email protected]

Location Countries

Lebanon

Location Countries

Lebanon

Administrative Informations


NCT ID

NCT02932852

Organization ID

CTP-007/15


Responsible Party

Sponsor

Study Sponsor

Vissum, Instituto Oftalmológico de Alicante

Collaborators

 Reviva Pharmaceuticals

Study Sponsor

Mona El Zarif, OD, Study Chair, Optica General


Verification Date

October 2016