Clinical study of subretinal transplantation of human embryo stem cell derived retinal pigment epitheliums in treatment of macular degeneration diseases

General Information

Summary The purpose of this study was to determine the safety and therapeutic effect of sub-retinal transplantation of human embryo stem cell derived retinal pigment epitheliums (hESC-RPE) in patients with macular degeneration diseases, and explore new treatment modalities for macular degeneration diseases (Age-related macular degeneration and Stargardt's macular dystrophy).
Clinical trials phase Phases 1/2
Start date (estimated) 2015-05-01
End date (estimated) 2019-12-31
Clinical feature
Label macular degeneration
Link http://purl.obolibrary.org/obo/DOID_4448
Description A retinal degeneration characterized by gradual deterioration of light-sensing cells in the tissues at the back of the eye and has_symptom vision loss.; Xref MGI.
Publications

Administrative Information

NCT number NCT02749734
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=ChiCTR-OCB-15006423
Other study identifiers
Name ChiCTR-OCB-15006423
Description Chinese Clinical Trial Registry (ChiCTR)
Name 2013CB967002
Source weblink https://clinicaltrials.gov/ct2/show/NCT02749734
Public contact
Email qinzyin@aliyun.com
Public email qinzyin@aliyun.com
First name Zhengqin
Last name Yin
Phone +86 023 68754401
Country
China
Sponsors Chinese Academy of Sciences
Southwest Hospital, China

Cells

Source pluripotent stem cell lines
Which differentiated cell type is used
Label retinal pigment epithelial cell
Link http://purl.obolibrary.org/obo/CL_0002586
Description An epithelial cell of the retinal pigmented epithelium.; This extended description was generated by ChatGPT and reviewed by the CellGuide team, who added references, and by the CL editors, who approved it for inclusion in CL. It may contain information that applies to only to some subtypes and species, and so should not be considered definitional. Retinal pigment epithelial (RPE) cells form a single layer of cells at the back of the eye sandwiched between the neurosensory retina and the choroid, playing a significant role in maintaining vision health. These pigment-laden cells are highly specialized and perform an array of metabolic and transport functions essential for the maintenance of the photoreceptor cells (rods and cones) in the retina. The pigmentation of RPE cells actively aids in the absorption of excess light and the prevention of light scattering, thus enhancing the eye's optical properties. The retinal pigment epithelium forms a key part of the blood/retina barrier. The cells have long sheet-like microvilli on their apical membrane that project into the light-sensitive outer segments of the photoreceptors, forming a close structural interaction. The basolateral membrane of the RPE interacts with the underlying Bruch’s membrane, which separates the RPE cells from fenestrated endothelium of the choriocapillaris. RPE cells support the photoreceptor by providing them with oxygen and nutrients (such as glucose, retinol and fatty acids) and removing waste products. They also recycle the visual pigment, in a process called the "visual cycle", where the RPE cells play a vital role in the regeneration of visual pigment (11-cis retinol) following the absorption of light. This is essential for the maintenance of photoreceptor excitability. Beyond this, RPE cells take part in the phagocytosis process, where they digest the shed ends of photoreceptor outer segments, thus, preventing the build-up of waste residue that could otherwise harm retinal health. They also secrete various factors, including growth factors required to maintain the structural integrity of choriocapillaris endothelium and photoreceptors, as well as immunosuppressive factors that play an important role in establishing the immune privilege of the eye.

Recruitment

Recruitment Status Active, not recruiting
Comment recruitment status Estimated number of participants according to Chinese Clinical Trial Registry (ChiCTR): 10; Estimated number of participants according to clinicaltrials.gov: 15.
Estimated number of participants 9
Contact institutions/departments