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Clinical trial protocol of efficacy and safety of wuzhishan miniature pig (WZSP) inbred corneal endothelial tissue slices in the treatment of bullous keratopathy

Clinical trial protocol of efficacy and safety of wuzhishan miniature pig (WZSP) inbred corneal endothelial tissue slices in the treatment of bullous keratopathy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048672
Enrollment
Unknown
Registered
2021-07-12
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

bullous keratopathy

Interventions

Test group :Heterogenous corneal endothelial transplantation

Sponsors

Beijing Tongren Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Clinical diagnosis of bullous keratopathy, patient with ocular pain as the main complaint, visual acuity as no light perception, and intraocular pressure <= 21 mmHg (measured by rebound tonometer) and stable; 2.Age 50 years or older, gender not limited; 3.Signed written informed consent, voluntary participation in the study, and good compliance.

Exclusion criteria

Exclusion criteria: 1.Patients with a history of serious cardiovascular, hepatic, renal, and other systemic diseases; 2.Patients with infectious diseases (including but not limited to: hepatitis B, hepatitis C, syphilis, acquired immunodeficiency syndrome); 3.Patients with a history of malignant blood disorders; 4.Patients with a history of malignant neoplasm; 5.History of allergy; 6.Premenopausal women or subjects with childbirth plans; 7.Adults diagnosed as mentally retarded or mentally incapacitated; 8.Patients who are severely depressed, anxious or otherwise considered psychologically inappropriate for this study; 9.Subjects who are otherwise considered by the study physician to be inappropriate for enrollment in the study.

Design outcomes

Primary

MeasureTime frame
Restoration of corneal transparency;

Secondary

MeasureTime frame
The degree to which perceived eye discomfort (e.g. pain) is relieved;Corneal endoscopy and in vivo confocal microscopy showed normal number and morphology of endothelial cells;Optical coherence tomography showed that corneal thickness reached normal range (central thickness 600-750 µm);

Countries

China

Contacts

Public ContactPan Zhiqiang

Beijing Tongren Hospital, Capital Medical University

panyj0526@sina.com+86 10 5826 9676

Outcome results

None listed

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