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Clinical study of human umbilical cord mesenchymal stem cells injection in the treatment of refractory non-infectious autoimmune uveitis

Clinical study of human umbilical cord mesenchymal stem cells injection in the treatment of refractory non-infectious autoimmune uveitis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049494
Enrollment
Unknown
Registered
2021-08-02
Start date
2022-06-01
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Uveitis

Interventions

Experimental group1:Intravenous infusion of low, medium and high dose human umbilical cord mesenchymal stem cells
Experimental group2:Intravenous infusion of human umbilical cord mesenchymal stem cells injection with appropriate dose twice (day 1 and day 29)

Sponsors

Tianjin Medical University Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, aged 18 to 60 years (including boundary value); 2. Patients with refractory non-infectious autoimmune uveitis (refractory is defined as: patients are difficult to tolerate hormone and / or immunosuppressive therapy due to drug side effects, or there is still persistent inflammation despite high-dose hormone combined with immunosuppressants were applied, or it is difficult to reduce prednisone to less than 10 mg/d after more than one year's treatment with immunosuppressants; 3. Voluntarily abide by the research procedures and ensure good compliance during the research period; 4. Fully understand the nature of this study and sign the written informed consent according to the guiding principles of research institutions and research centers.

Exclusion criteria

Exclusion criteria: 1. There are other retinal diseases that affect vision, such as diabetic retinopathy, retinal detachment, etc. 2. Active infection, including hepatitis B, hepatitis C, tuberculosis or HIV positive; 3. Those with severe cardiac dysfunction (NYHA grade II and above of the New York Heart Disease Association of the United States); 4. Patients with severe liver function injury (AST > 5 times the normal upper limit); 5. Patients with renal dysfunction (estimated glomerular filtration rate 240 mg/ day or a large number of irregular use of systemic corticosteroids in other diseases) within 3 days before enrollment, which may affect the efficacy of other diseases; 10. Allergic to low molecular weight heparin or human serum albumin that may interfere with the compliance of subjects or the evaluation / progress of the study; 11. Participating in other interventional clinical studies or participated in other interventional clinical studies within 3 months before screening; 12. History of malignant tumor; 13. Other situations that the researchers consider unsuitable for clinical study.

Design outcomes

Primary

MeasureTime frame
Safety evaluation;

Secondary

MeasureTime frame
Effectiveness evaluation;

Countries

China

Contacts

Public ContactZhang Xiaomin

Tianjin Medical University Eye Hospital

xzhang08@tmu.edu.cn+86 13920023990

Outcome results

None listed

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