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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
Sponsor:
Information provided by (Responsible Party):
Vivek Singh, L.V. Prasad Eye Institute

Tracking Information
First Submitted Date  ICMJE October 20, 2016
First Posted Date  ICMJE October 28, 2016
Last Update Posted Date March 6, 2018
Actual Study Start Date  ICMJE August 31, 2016
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2016)
Ocular or systemic adverse effects [ Time Frame: until 3months after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02948023 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2016)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cells Therapy for Corneal Blindness
Official Title  ICMJE Ex-vivo Cultivated Limbal Stem Cell Transplantation for Treatment of Superficial Corneal Pathologies
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Corneal Injuries
  • Corneal Burns
  • Corneal Scars and Opacities
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Ex-vivo cultivated limbal stem cell pool
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 3, 2018)
100
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2016)
20
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sayan Basu, MBBS, MS 9140-30612625 ext 2625 sayanbasu@lvpei.org
Contact: Vivek Singh, MSc PhD 9140-30612286 ext 2286 viveksingh@lvpei.org
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02948023
Other Study ID Numbers  ICMJE LVPEI-2014-1 Version 1 15Jan14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vivek Singh, L.V. Prasad Eye Institute
Study Sponsor  ICMJE L.V. Prasad Eye Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sayan Basu, MBBS, MS LV Prasad Eye Institiute
Principal Investigator: Vivek Singh, MSc PhD LV Prasad Eye Institiute
PRS Account L.V. Prasad Eye Institute
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP