A clinical trial to study the safety and efficacy of ReliNethra C-Au (Autologous Conjunctival epithelial cell graft) in patients with pterygium

A prospective open-label single-arm multi-centric clinical study to assess the safety and efficacy of ReliNethra C-Au (Autologous Conjunctival epithelial cell graft) in patients with pterygium

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000641

Enrollment

Registered

2009-08-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Patients requiring surgical correction for diseased or damaged conjunctiva.

Interventions

Intervention1: ReliNethra C-Au (Autologous conjunctival epithelial cell graft): A monolayered conjunctival epithelial cell graft comprising of conjunctival epithelial cells cultured ex vivo on a 4 cm

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To evaluate the safety of ReliNethraTMC-AuTimepoint: day 1, day 7, day 14, day 30, day 90 and day 180	—

Countries

India

Contacts

Public ContactDrChandra Viswanathan

Reliance Life Sciences Pvt. Ltd.

chandra.viswanathan@ril.com02240678352

Outcome results

None listed

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