Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394232
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-04-15
Brief Title:
Safety Efficacy of Eyecyte-RPE in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
Sponsor:
Eyestem Research Pvt Ltd
Organization:
Eyestem Research Pvt Ltd
Study Overview
Official Title:
A Phase 12a Multi-Center Dose-Escalation Study to Evaluate the Safety Efficacy of Eyecyte-RPE When Administered as a Single-dose Subretinal Injection in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical study is to evaluate the safety and efficacy of novel stem cell formulation in patients having Geographic Atrophy GA Secondary to Dry Age-related Macular Degeneration d-AMD
The main questions it aims to answer are
Safety and tolerability of the novel stem cell formulation
Potential efficacy of the novel stem cell formulation
Participants will receive a single subretinal injection in their study eye and followed up for safety
This is an India only study and the product is developed indigenously
The main questions it aims to answer are
Safety and tolerability of the novel stem cell formulation
Potential efficacy of the novel stem cell formulation
Participants will receive a single subretinal injection in their study eye and followed up for safety
This is an India only study and the product is developed indigenously
Detailed Description:
Age-related Macular Degeneration AMD is a leading cause of vision impairment in the elderly and substantially affects the quality of life of an individual Although the exact pathophysiological mechanisms behind the disease are multifactorial and complex several genetic and environmental risk factors are associated with AMD such as age cigarette smoking hypertension abdominal obesity dietary fat and low physical activity
Geographic Atrophy GA is the late stage of dry AMDd-AMD GA is a slow but inexorably progressive disease that causes irreversible blindness over time Several new non-invasive tools such as Fundus Autofluorescence FAF Optical Coherence Tomography OCT and OCT Angiography OCT-A are being used to enable early diagnosis and follow up in these patients Despite these advances there are currently no approved treatments for GA that can replace the damaged RPE photoreceptors or outer retinal layers In recent years stem cell replacement therapy is being evaluated as an alternative to treat d-AMD
In the pursuit to find a promising solution for d-AMD which is an unmet medical need globally Eyestem has been striving to develop a safe and effective stem-cell based therapy
Theoretically human induced pluripotent stem cellshiPSCs derived Eyecyte-RPE developed by Eyestem can help replace the damaged or lost retinal pigment epithelial RPE cells and potentially enable tissue regeneration in the diseased retina In addition stem cells can perform multiple functions such as immunoregulation prevention of apoptosis in sensory neurons and secretion of neurotrophic factors The latest stem cell transplantation studies performed by other research groups has been able to demonstrate that this therapy has a promising approach to restore visual function in eyes with degenerative retinal diseases
The results of the pre-clinical safety and efficacy studies with Eyecyte-RPE have been very encouraging It has been shown to provide significant beneficial effects on the degenerating retina in animals without any significant safety concerns suggesting that this therapy may have substantial therapeutic value in d-AMD
Geographic Atrophy GA is the late stage of dry AMDd-AMD GA is a slow but inexorably progressive disease that causes irreversible blindness over time Several new non-invasive tools such as Fundus Autofluorescence FAF Optical Coherence Tomography OCT and OCT Angiography OCT-A are being used to enable early diagnosis and follow up in these patients Despite these advances there are currently no approved treatments for GA that can replace the damaged RPE photoreceptors or outer retinal layers In recent years stem cell replacement therapy is being evaluated as an alternative to treat d-AMD
In the pursuit to find a promising solution for d-AMD which is an unmet medical need globally Eyestem has been striving to develop a safe and effective stem-cell based therapy
Theoretically human induced pluripotent stem cellshiPSCs derived Eyecyte-RPE developed by Eyestem can help replace the damaged or lost retinal pigment epithelial RPE cells and potentially enable tissue regeneration in the diseased retina In addition stem cells can perform multiple functions such as immunoregulation prevention of apoptosis in sensory neurons and secretion of neurotrophic factors The latest stem cell transplantation studies performed by other research groups has been able to demonstrate that this therapy has a promising approach to restore visual function in eyes with degenerative retinal diseases
The results of the pre-clinical safety and efficacy studies with Eyecyte-RPE have been very encouraging It has been shown to provide significant beneficial effects on the degenerating retina in animals without any significant safety concerns suggesting that this therapy may have substantial therapeutic value in d-AMD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None