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Effective and safety evaluation of optic nerve canal decompression of optic nerve canal by nasoscope with human umbilical cord derived mesenchymal stem cells (HU - MSCs) transplantation in traumatic optic neuropathy

Effective and safety evaluation of optic nerve canal decompression of optic nerve canal by nasoscope with human umbilical cord derived mesenchymal stem cells (HU - MSCs) transplantation in traumatic optic neuropathy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14005093
Enrollment
Unknown
Registered
2014-08-06
Start date
2014-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

traumatic optic neuropathy

Interventions

control group:normal saline with 1% human serum albumin

Sponsors

Cell Biotherapy Center, Daping Hospital, The Third Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Good adherence to patients and their families with informed consents; 2. patients of ophthalmology, aged from 16 to 65 years old, both gender; 3. Clinical diagnosis of patients with traumatic optic neuropathy; 4. Injury time within 1 month with stable vital signs; 5. The wounded eye's best corrected vision less than or equal to 0.3; 6. The wounded eye without penetrating wound and fracture wound, refractive stroma transparent.

Exclusion criteria

Exclusion criteria: 1. Intracranial bleeding due to trauma, traumatic brain injury and other vital signs is not steady, or accompany with heart, lung disease, or severe liver and kidney function; 2. The wounded eyes with severe ocular blunt trauma:detached peripheral iris, lens dislocation, ciliary body detachment or laceration, vitreous hemorrhage, retinal detachment, retina and choroid laceration, etc; 3. HIV infected with CD4 less than 50/mm3; 4. Have the bone marrow, lungs, liver, pancreas, or history of small bowel transplantation; 5. Chronic renal failure need hemodialysis or peritoneal dialysis; 6. Accompany with high surgical risk diseases, such as sphenoid sinus dysplasia, cerebrospinal fluid rhinorrhea, internal carotid artery dissection aneurysm, etc; 7. Patient participating or having participated in a clinical trial with another investigational drug Within 30 days before the start of this clinical trial; 8. Patient is pregnant or nursing; 9. History of patient is allergic to biological products, allergic reactions or other serious reaction; 10. Researchers believe that patients cannot participate in this clinical trail for other reasons.

Design outcomes

Primary

MeasureTime frame
vision;view;VEP;

Countries

China

Contacts

Public ContactXiang Xu
xiangxu@ymail.com+86 13637843870

Outcome results

None listed

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