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A clinical study of human MSC induced retinal pigment epithelium cells transplantation in the treatment of diabetic retinopathy

A clinical study of human MSC induced retinal pigment epithelium cells transplantation in the treatment of diabetic retinopathy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016870
Enrollment
Unknown
Registered
2018-06-30
Start date
2018-08-01
Completion date
Unknown
Last updated
2018-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic retinopathy

Interventions

one cohort:hMSC-RPE cells transplantation

Sponsors

Shenzhen Ruipuxun Academy for Stem Cell & Regenerative Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years male and female; 2. Clinical diagnosis is diabetic retinopathy with one or double visually impaired eyes; 3. There is no other ophthalmic diseases except diabetic retinopathy; 4. Conventional therapies are not effective for the diabetic retinopathy treatment; 5. Good function situation of immportant organsand No systemic infection; 6. Non tumor patient; 7. Patient with a history of anaphylaxis; 8. Patient without immunodeficiency disease; 9. Having signed informed consent papers; 10. Patient and family members agree to cooperate follow-up with good compliance.

Exclusion criteria

Exclusion criteria: 1. Suffering from other ophthalmic diseases besides diabetic retinopathy; 2. Progressive Cataract causing difficulty of retina examination; 3. Any eye surgery other than cataract surgery within previous 3 months; 4. History of retina detachment repair in the study eye; 5. Uveitis or other intraocular inflammatory disease in the study eye; 6. Participation in any clinical trial of a drug by ocular or systemic administration within the latest 6 months; 7. History of malignancy; 8. History of myocardial infarction, liver function failure and kidney function failure; 9. Suffering from immunodeficiency or Any current immunosuppressive therapy and corticosteroid treatment; 10. A history of allergies; 11. Pregnant women; 12. Any other condition that affects patient compliance, patient safety, and the outcome of this clinical study.

Design outcomes

Primary

MeasureTime frame
Early treatment of diabetic retinopathy eye chart (ETDRs);Fluorescein angiography;Optical coherent tomography (OCT);Flash electroretinogram (FERG);fundus photography;Best corrected visual acuity;Multifocal ERG;HRA autofluorescence;

Secondary

MeasureTime frame
Anterior segment image;Intraocular pressure;microperimetry;Center and peripheral field of vision or Humphrey 24-2;A or B-ultrasound;Corneal endothelial count;

Countries

China

Contacts

Public ContactZhao Zhenlin

Shenzhen Ruipuxun Academy for Stem Cell & Regenerative Medicine

zhaozl2006@163.com+86 13828895409

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026