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Stem Cells Therapy for Corneal Blindness (ExCell)

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ClinicalTrials.gov Identifier: NCT02948023
Recruitment Status : Recruiting
First Posted : October 28, 2016
Last Update Posted : March 6, 2018
Information provided by (Responsible Party):
Vivek Singh, L.V. Prasad Eye Institute

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.

Condition or disease Intervention/treatment Phase
Corneal Injuries Corneal Burns Corneal Scars and Opacities Biological: Ex-vivo cultivated limbal stem cell pool Phase 1

Detailed Description:
In this prospective interventional study patients with superficial corneal pathologies like scars, ulcers and burns will undergo a surgical procedure. Limbal ring from a cadaveric donor tissue, which is therapeutically accepted and serologically tested, is collected. This tissue will then be cultivated in the stem cell biology laboratory using standardized culture technique. Briefly the limbal tissue will be cut up into small pieces and digested overnight using an enzyme (Collagenase L). The cells obtained from the digest will be cultured on a petri-dish using 2% serum and growth factors. The cultured cells will be passaged three times to remove all epithelial cells from the culture. In the second procedure, the central corneal epithelium will be removed using a surgical sponge. 0.1ml of stromal cells in a concentration of 5x10^3 cells/uL diluted in the thrombin component of fibrin glue (TISEEL, Baxter) will be applied to the debrided corneal stroma. A soft bandage contact lens will be placed over the cornea at the end of the procedure. The patient will receive topical antibiotic and steroid eye drops in the post-operative period. Periodic comprehensive ophthalmic evaluation along with anterior segment optical coherence tomography (ASOCT) scanning and slit-lamp photography will be done at day 1, day 7, day 45 and day 90.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ex-vivo Cultivated Limbal Stem Cell Transplantation for Treatment of Superficial Corneal Pathologies
Actual Study Start Date : August 31, 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Standard Surgical therapy
Includes the control group that fulfills the inclusion criteria
Active Comparator: Ex-vivo cultivated limbal stem cell pool
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
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.

Primary Outcome Measures :
  1. Ocular or systemic adverse effects [ Time Frame: until 3months after surgery ]

Secondary Outcome Measures :
  1. Visual improvement after treatment. [ Time Frame: until 3months after surgery ]
    Checking for the improvement in visual acuity that will be calculated using LogMAR chart (where 20/20 vision is normal).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male and Female participants who are aged between 18-60 years.
  2. 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.
  3. Eyes with otherwise normal.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948023

Contact: Sayan Basu, MBBS, MS 9140-30612625 ext 2625 sayanbasu@lvpei.org
Contact: Vivek Singh, MSc PhD 9140-30612286 ext 2286 viveksingh@lvpei.org

LV Prasad Eye Institute Recruiting
Hyderabad, Telangana, India, 500034
Contact: Sayan Basu, MBBS, MS    +9140 3061 2625 ext 2625    sayanbasu@lvpei.org   
Contact: Vivek Singh Singh, MSc PhD    +9140 3061 2286 ext 2286    viveksingh@lvpei.org   
Sponsors and Collaborators
L.V. Prasad Eye Institute
Principal Investigator: Sayan Basu, MBBS, MS LV Prasad Eye Institiute
Principal Investigator: Vivek Singh, MSc PhD LV Prasad Eye Institiute
  Study Documents (Full-Text)

Documents provided by Vivek Singh, L.V. Prasad Eye Institute:
Study Protocol  [PDF] August 19, 2017
Informed Consent Form  [PDF] August 19, 2017

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

Responsible Party: Vivek Singh, Dr, L.V. Prasad Eye Institute
ClinicalTrials.gov Identifier: NCT02948023     History of Changes
Other Study ID Numbers: LVPEI-2014-1 Version 1 15Jan14
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Corneal Injuries
Corneal Opacity
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Corneal Diseases
Eye Diseases
Wounds and Injuries