A PhaseI/IIa Study to Determine the Safety and Tolerability of MA09-hRPE Cells in Patients With Advanced Dry AMD

NCT ID: NCT01674829

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2017-09-30

Brief Summary

To evaluate the safety and tolerability of MA09-hRPE cellular therapy in patients with advanced dry AMD To evaluate the safety of the surgical procedures when used to implant MA09-hRPE cells To assess the number of hRPE cells to be transplanted in future studies To evaluate on an exploratory basis potential efficacy endpoints to be used in future studies of MA09-hRPE cellular therapy.

Conditions

Dry Age Related Macular Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Biological: MA09-hRPE Cellular therapy Cohort 1 Dose 1

Group Type: EXPERIMENTAL

MA09-hRPE

Intervention Type: BIOLOGICAL

Transplantation of MA09-hRPE cells accoding to the assigned dose group

Cohort 2

Biological: MA09-hRPE Cellular therapy Cohort 2 Dose 2

Group Type: EXPERIMENTAL

MA09-hRPE

Intervention Type: BIOLOGICAL

Transplantation of MA09-hRPE cells accoding to the assigned dose group

Cohort 3

Biological: MA09-hRPE Cellular therapy Cohort 3 Dose 3

Group Type: EXPERIMENTAL

MA09-hRPE

Intervention Type: BIOLOGICAL

Transplantation of MA09-hRPE cells accoding to the assigned dose group

Cohort 4

Biological: MA09-hRPE Cellular therapy Cohort 4 Dose 4

Group Type: EXPERIMENTAL

MA09-hRPE

Intervention Type: BIOLOGICAL

Transplantation of MA09-hRPE cells accoding to the assigned dose group

Interventions

MA09-hRPE

Transplantation of MA09-hRPE cells accoding to the assigned dose group

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Adult male or female over 55 years of age. Patient should be in sufficiently good health to reasonably expect survival for at least four years after treatment
• Clinical findings consistent with advanced dry AMD
• GA defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, and FA.
• No evidence of current or prior choroidal neovascularization in the treated eye
• The visual acuity (BCVA) of the eye to receive the transplant found to be eligible for trial based on study protocol
• Electrophysiological findings consistent with advanced dry AMD.
• Medically suitable to undergo vitrectomy and subretinal injection.
• Medically suitable for general anesthesia or waking sedation, if needed.
• Medically suitable for transplantation of an embryonic stem cell line

Exclusion Criteria

• Presence of active or inactive CNV in the eye to be treated.
• Presence or history of retinal dystrophy, retinitis pigmentosa, chorioretinitis, central serious choroidopathy, diabetic retinopathy or other retinal vascular or degenerative disease other than ARMD.
• History of optic neuropathy.
• Macular atrophy due to causes other than AMD.
• Presence of glaucomatous optic neuropathy in the study eye, uncontrolled IOP, or use of two or more agents to control IOP (acetazolamide, beta blocker, alpha-1-agonist, prostaglandins, anhydrous carbonic inhibitors)
• Cataract of sufficient severity likely to necessitate surgical extraction within 1 year.
• History of retinal detachment repair in the study eye.
• History of myocardial infarction in previous 12 months.
• History of diabetes mellitus.
• History of cognitive impairments or dementia which may impact the patients ability participate in the informed consent process and to appropriately complete evaluations.
• Any immunodeficiency.
• Any abnormalities in laboratory test result.
• Serologic evidence of infection with Hepatitis B, Hepatitis C, or HIV.
• Current participation in any other clinical trial.
• Participation within previous 6 months in any clinical trial of a drug by ocular or systemic administration.
• Any other sight-threatening ocular disease.
• Ocular lens removal within previous 3 months.
• Ocular surgery in the study eye in the previous 3 months
• 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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHABiotech CO., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yeong je Seong

Role: PRINCIPAL_INVESTIGATOR

CHA Bundang Medical Center

Locations

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

CHA CTP 1101

Identifier Type: -

Identifier Source: org_study_id