A clinical trial to study the safety and efficacy of ReliNethra C-Au (Autologous Conjunctival epithelial cell graft) in patients with pterygium
Phase 1
Completed
- Conditions
- Health Condition 1: null- Patients requiring surgical correction for diseased or damaged conjunctiva.
- Registration Number
- CTRI/2009/091/000641
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
1. Male or female patients of 18 years and above
2. Patients with damaged or diseased conjunctival surface requiring surgical correction of pterygium, symblepharon, chronic allergic conjunctivitis, toxic epidermal necrolysis, wide field excision of tumors, and/or chemical injuries (as confirmed by history, prior medical records and/or clinical examination)
Exclusion Criteria
1. History of significant hematological, hepatic, renal, cardiovascular, respiratory, neurological, endocrinal or allergic disease
2. Patient with documented HIV infection/AIDS
3. Patients with history of diabetes
4. Patients with any ocular surface abnormality in the other eye
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary objective will be to evaluate the efficacy of ReliNethra C-Au defined as restoration of physiological and functional conjunctival epithelium.Timepoint: day 1, day 7, day 14, day 30, day 90 and day 180
- Secondary Outcome Measures
Name Time Method To evaluate the safety of ReliNethraTMC-AuTimepoint: day 1, day 7, day 14, day 30, day 90 and day 180