iPS cell-derived corneal endothelial cell substitutes for bullous keratopathy
- Conditions
- Bullous keratopathyEdema, corneal
- Registration Number
- JPRN-jRCTa031210199
- Lead Sponsor
- Hirayama Masatoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3
1) A diagnosis of bullous keratopathy after corneal transplantation, including at least one previous penetrating keratoplasty.
2) Forty five years of age or older and under 85 years of age at the time of consent acquisition (male or female)
3) A central corneal endothelial cell density of less than 500 cells/mm^2 measured by specular microscope or confocal microscope, or undetactable.
4) Voluntary written consent to participate in the study.
1) Patients with undiagnosed keratoconjunctival disease.
2) Central corneal thickness of 1200 micro meter or blood vessel invasion in the stroma of cornea.
3) i) Active corneal infection OR ii) Active systemic infections (bacteria, fungi, positive in viral test such as hepatitis B virus, hepatitis C virus, etc.).
4) IOP >= 30 mmHg or even with glaucoma drugs administration IOP >= 21 mmHg
5) Diabetes that it difficult to control(HbA1C 8.0% or higher).(This can be omitted in the primary verification of eligibility.)
6) Neovascularization in the iridocorneal angle or after neovascular glaucoma treatment.
7) Medical history of hypersensitivity to anesthetic(xylocaine injection solution), antibiotics(levofloxacin ophthalmic solution),steroids(sanbetason ophthalmic and otorhinologic solution 0.1%, flumetholon ophthalmic suspension 0.1%),glaucoma treatment(prostaglandin analog, beta inhibitor,azopt otorhinologic solution, glanatec otorhinologic solution and so on),used during perioperative and postoperative observation.
8) Scheduled to undergo internal eye surgery during the study.
9) Medical history of cancer
10) Presence of significant hepatic failure (with either AST or ALT higher than 100 IU/L).(This can be omitted in the primary verification of eligibility.)
11) Presence of renal failure requiring dialysis(serum creatinine level 1.5 mg/dl or higher).(This can be omitted in the primary verification of eligibility.)
12) Systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher, even with antihypertensive drug.
13) Not consent to contraception or hopes his partner's pregnancy during the study.
14) Cannot endure ophthalmic surgery under local anesthesia (Extreme claustrophobia, etc.).
15) Participation in other clinical trials one month prior to when informed consent is obtained
16) Other cases where the principal investigator or sub investigator decides the subject is unsuitable for the study.
*1 : The following items refer to transplanted eyes. 1)-4), 6)and 8).
*2 : These tests examine the patient's blood type and HLA gene type during screening. The results are not used to determine exclusion criteria, regardless of whether his or her blood type or HLA type matches that of the iPS cell donor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <Safety endpoint><br>1) safety endpoint (systemic)<br>All adverse events, including systemic symptoms<br>2) safety endpoint (ophthalmologic)<br>[The following adverse events caused by iPS cell-derived corneal endothelium substitute cells]<br> - Unintended cell proliferation<br> - Increased intraocular pressure<br> - Rejection reaction<br>[The following adverse events resulting from transplant surgery and procedures]<br> - Infectious disease<br> - Cataract progression<br> - Expulsive Hemorrhage
- Secondary Outcome Measures
Name Time Method <Efficacy endpoint><br> - Visual acuity<br> - Corneal thickness