An Early Phase 1 interventional study of Lipoaspiration and Transplantation in Hereditary Corneal Dystrophy and Keratoconus, sponsored by Vissum, Instituto Oftalmológico de Alicante. Status unknown at 1 site in Lebanon. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-13.
Sponsored by Vissum, Instituto Oftalmológico de Alicante · Early Phase 1, Interventional, and Treatment
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)
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).
31 studies on the registry are indexed under Corneal Dystrophies, Hereditary; 9 are open to participants now.
This study's planned enrollment of 12 is below the median of 25 across 19 interventional studies indexed under Corneal Dystrophies, Hereditary.
Browse Corneal Dystrophies, Hereditary studies →Vissum, Instituto Oftalmológico de Alicante is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
lipoaspiration and transplantation of ADAS alone without scaffold
Procedure: Lipoaspiration · Procedure: Transplantation
Lipoaspiration and transplantation of scaffold (human corneal decellularized lamina) without ADAS
Procedure: Lipoaspiration · Procedure: Transplantation
Lipoaspiration and transplantation of ADAS cellularized on scaffold (the human corneal decellularized lamina)
Procedure: Lipoaspiration · Procedure: Transplantation
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
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
Time frame: post operative visit at 1 day, 1 month, 3 months and 6 months
Corneal Thickness
At each post operative visit a measurement of corneal pachymetry of the transplanted cornea will be carried out to detect any abnormal evolution
Time frame: post operative visit at 1 day, 1 month, 3 months and 6 months
Topopgraphy
At each post operative visit a measurement of Anterior surface topography of the transplanted cornea will be carried out to detect any abnormal evolution
Time frame: post operative visit at 1 month, 3 months and 6 months
Anterior segment Optical Coherence Tomography
At each post operative visit a measurement anterior segment Optical Coherence Tomography of the transplanted cornea will be carried out to detect any abnormal evolution
Time frame: post operative visit at 1 month, 3 months and 6 months
Slit Lamp Observation
At each post operative visit, the corneal aspect relative to new tissue will be evaluated by slit lamp observation
Time frame: post operative visit at 1 day, 1 month, 3 months and 6 months
refraction measurement
At each post operative visit, the corneal aspect relative to increase in irregular astigmatism will be evaluated by refraction measurement
Time frame: post operative visit at 1 day, 1 month, 3 months and 6 months
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Corneal Dystrophies, Hereditary →
Vissum, Instituto Oftalmológico de Alicante