RecruitingPhase 1 / Phase 2

Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Insulin supplementation can be either in the form of multiple daily insulin injections (manual or via pump) or by biological replacement of the insulin-producing beta cells through transplantation, which provides a natural source of insulin."
  • "However, it is well established that exogenous insulin injection therapy is suboptimal in preventing fluctuation in blood sugar levels (i.e., hyper- and hypoglycemia) due to mis-dosing and other factors."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests placing pancreatic islets, groups of cells that make insulin, into the front part of the eye. It is for adults with type 1 or type 2 diabetes who have very little or no sight in at least one eye. After the transplant, patients use eye drops to help prevent rejection of the cells.

The intervention in this trial is intraocular islet transplantation. A single dose of 1000 - 3000 Islet Equivalents (IEQ)/kg recipient body weight (BW) will be infused into the anterior chamber of the eye through a self-sealing incision in the peripheral cornea. The procedure is projected to take approximately 20-30 minutes. Transplant recipients in this study will receive localized maintenance immunosuppression via topical application of eye-drops.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 75, with no history of not following medical care instructions.
  • Have type 1 or type 2 diabetes, whether or not you use insulin.
  • Have at least one eye that can only see hand movements or has even less sight, including no light perception.
  • The eye must have its natural lens or a stable artificial lens.
  • The clear front surface of the eye and the structures behind it must be normal and easy for the doctor to see.
  • Have stable kidney function, including if you have a kidney transplant.
  • Be able to give written consent to join.
  • Be mentally stable and able to follow the study steps.

Who can't join

  • Certain problems in the eye having surgery, such as a cloudy or swollen front surface, no lens, a very narrow drainage angle, uncontrolled glaucoma or past glaucoma surgery, uncontrolled inflammation, or silicone left from eye surgery.
  • Allergy to steroid eye drops or immune-control medicines such as cyclosporine or tacrolimus.
  • HbA1c, a measure of average blood sugar, above 10%; blood pressure above 160 for the top number or 100 for the bottom number; or kidney test results outside the study limits.
  • Certain immune test results that raise transplant concerns, including a positive donor crossmatch or antibodies against a transplanted kidney.
  • Pregnancy, breastfeeding, or not agreeing to the study's birth control rules. Men must not plan to father a child during the study or within 4 months after stopping.
  • Certain infections, a negative test for past Epstein-Barr virus infection, cancer not declared cured or in remission, or active alcohol or drug abuse.
  • Certain low blood cell counts, severe heart disease, or cholesterol or blood fat levels above study limits in people with a kidney transplant.
  • Long-term steroid treatment, except a small replacement dose allowed by the study; an experimental drug within 4 weeks; a live vaccine within 2 months; or another condition the study doctor considers unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Patients who meet all of the following criteria are eligible for participation in the study: Ophthalmic inclusion criteria: 1. Patient with at least one eye with extensive loss of vision from hand motion to no light perception. 2. Phakic or pseudophakic with a stable intraocular lens in the blind eye. 3. Normal cornea with good visualization of the anterior segment. 4. Normal anterior segment anatomy including the iris bed. General and metabolic inclusion criteria: 1. Male and female subjects ages 18 to 75 years of age and no history of non-compliance. 2. Clinical history compatible with T1D or T2D with or without insulin-dependence at the time of enrollment. 3. Stable renal function of native or transplanted kidney if applicable. 4. Ability to provide written informed consent. 5. Mentally stable and able to comply with the procedures of the study protocol. Exclusion Criteria: Patients who meet any of these criteria are not eligible for participation in the study: Ophthalmic exclusion criteria (only in surgical eye): 1. Poor visualization of the anterior chamber (corneal opacity, corneal edema, Herpes Keratitis). 2. Aphakic status (no lens). 3. Narrow angle of iris anatomy: Spade Scale IV. 4. History of uncontrolled glaucoma or glaucoma that had required surgical intervention (e.g., trabeculectomy or shunting devices). 5. Active uncontrolled uveitis. 6. Presence of silicone in the anterior segment after complex diabetic retinopathy surgery. 7. History of allergy to topical steroids and immune-modulatory drugs including CSA and Tacrolimus. General and metabolic exclusion criteria: 1. HbA1c \>10%. 2. Blood Pressure: SBP \>160 mmHg or DBP \>100 mmHg. 3. Calculated GFR of ≤40 mL/min/1.73 m2 for patients with kidney transplant or \<80 mL/min/1.73 m2 for those without kidney transplant, using the subject's measured serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation1. 4. Strict vegetarians (vegans) will be excluded only if their estimated GFR is ≤35 mL/min/1.73 m2 for patients with kidney transplant or \<70 mL/min/1.73 m2 for those without kidney transplant. 5. Proteinuria (albumin/creatinine ratio or ACr \>300mg/dl) of new onset or since kidney transplantation if applicable. 6. Calculated panel-reactive anti-HLA antibodies \>20%. 7. Positive crossmatch. 8. Antibodies (i.e., presumed de-novo) to the kidney transplant donor, if applicable. 9. For female subjects: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study (24 months) or within 4 months after discontinuation, or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable. 10. Presence or history of active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB). Subjects with laboratory evidence of active infection are excluded even in the absence of clinical evidence of active infection. 11. Negative screen for Epstein-Barr Virus (EBV) by IgG determination. 12. Invasive aspergillus, histoplasmosis, and coccidioidomycosis infection within one year prior to study enrollment. 13. Active malignancy (cancer) except if successfully treated and declared cancer-free and/or in-remission by the oncologist. 14. Known active alcohol or substance abuse. 15. Baseline Hb below the lower limits of normal at the local laboratory; lymphopenia (\<1,000/µL), neutropenia (\<1,500/µL), or thrombocytopenia (platelets \<100,000/µL). Participants with lymphopenia are allowed if the investigator determines there is no additional risk with additional clearance from a hematologist. 16. Severe co-existing cardiac disease, characterized by any one of these conditions: 1. Recent myocardial infarction (within past 6 months). 2. Evidence of ischemia on functional cardiac exam within the last year. 3. Left ventricular ejection fraction \<30%. 17. Hyperlipidemia despite medical therapy (fasting low-density lipoprotein \[LDL\] cholesterol \>130 mg/dL, treated or untreated; and/or fasting triglycerides \>200 mg/dL) for patients with kidney transplant. 18. Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for the use of ≤5 mg prednisone daily, or an equivalent dose of hydrocortisone, for physiological replacement only. 19. Use of any investigational agents within 4 weeks of enrollment. 20. Administration of live attenuated vaccine(s) within 2 months of enrollment. 21. Any medical condition that, in the opinion of the investigator, will interfere with the safe participation in the trial.

Study sites (2)

FL