NCT02948023

Brief Summary

This is a investigative initiated, comparative pilot clinical trial to ascertain the safety of application of ex-vivo cultivated limbal stem cells in human eyes for treating different superficial corneal pathologies. Pre-clinical work in murine models have already demonstrated efficacy of this technique in curing murine corneal pathologies.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

2.4 years

First QC Date

October 20, 2016

Last Update Submit

March 3, 2018

Conditions

Corneal InjuriesCorneal BurnsCorneal Scars and Opacities

Outcome Measures

Primary Outcomes (1)

  • Ocular or systemic adverse effects

    until 3months after surgery

Secondary Outcomes (1)

  • Visual improvement after treatment.

    until 3months after surgery

Study Arms (2)

Standard Surgical therapy

NO INTERVENTION

Includes the control group that fulfills the inclusion criteria

Ex-vivo cultivated limbal stem cell pool

ACTIVE COMPARATOR

0.5 million stromal and epithelial cells will be incorporated in 0.05ml of commercially available fibrin glue and pasted over the corneal lesion after epithelial debridement.

Biological: Ex-vivo cultivated limbal stem cell pool

Interventions

Ex-vivo cultivated limbal stem cell poolBIOLOGICAL

0.5 million stromal and epithelial cells will be incorporated in 0.05ml of commercially available fibrin glue and pasted over the corneal lesion after epithelial debridement.

Ex-vivo cultivated limbal stem cell pool

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and Female participants who are aged between 18-60 years.
  • Patients who are having with unilateral blindness due to superficial (defined as involving the anterior 200 microns of the corneal stroma on ASOCT imaging) corneal wounds, ulcers, burns and scars.
  • Eyes with otherwise normal.

You may not qualify if:

  • Active infection, proven by microbiology.
  • Unknown etiology, post-herpetic eye disease or eyes with active intra-ocular inflammation.
  • Children (\<18 years of age).
  • Inability/refusal to give written informed consent or to undergo any of the anterior segment imaging tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LV Prasad Eye Institute

Hyderabad, Telangana, 500034, India

RECRUITING

Related Publications (2)

  • Basu S, Hertsenberg AJ, Funderburgh ML, Burrow MK, Mann MM, Du Y, Lathrop KL, Syed-Picard FN, Adams SM, Birk DE, Funderburgh JL. Human limbal biopsy-derived stromal stem cells prevent corneal scarring. Sci Transl Med. 2014 Dec 10;6(266):266ra172. doi: 10.1126/scitranslmed.3009644.

    PMID: 25504883RESULT

  • Basu S, Damala M, Singh V. Limbal Stromal Stem Cell Therapy for Acute and Chronic Superficial Corneal Pathologies: Early Clinical Outcomes of The Funderburgh Technique. Investigative Ophthalmology & Visual Science. 2017 Jun 23;58(8):3371-337

    RESULT

MeSH Terms

Conditions

Corneal Injuries

Condition Hierarchy (Ancestors)

Eye InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesCorneal DiseasesEye DiseasesWounds and Injuries

Study Officials

  • Sayan Basu, MBBS, MS

    LV Prasad Eye Institiute

    PRINCIPAL INVESTIGATOR

  • Vivek Singh, MSc PhD

    LV Prasad Eye Institiute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sayan Basu, MBBS, MS

CONTACT

9140-30612625sayanbasu@lvpei.org

Vivek Singh, MSc PhD

CONTACT

9140-30612286viveksingh@lvpei.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 28, 2016

Study Start

August 31, 2016

Primary Completion

February 1, 2019

Study Completion

August 1, 2019

Last Updated

March 6, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)