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Validation and Sterility Evaluation Protocol for Autologous Serum Eye Drops for human use

Pilot validation study for constituents of Autologous Serum Eye Drop (ASED) preparation and serial sterility testing - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/088860
Enrollment
20
Registered
2025-06-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

None listed

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Manipal Academy of Higher Education
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Any blood donors who are eligible to donate as per the DGHS guidelines for blood donor selection as available publicly and amended from time to time.

Exclusion criteria

Exclusion criteria: Any donor who is not eligible to donate/ TTI Reactive donors

Design outcomes

Primary

MeasureTime frame
To validate and standardize the preparation protocolTimepoint: Baseline—

Secondary

MeasureTime frame
To assess the constituents of Autologous serum Eye drops preparation (ASED)Timepoint: 0 day;To determine post-thaw sterility of the preparation by serial sterility testing for suitability in human useTimepoint: 48 hours and 72 hours—

Countries

India

Contacts

Public ContactDr Deep Madkaiker

Kasturba Medical College, Manipal

deepmadk01@gmail.com9975749849

Outcome results

None listed

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