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Limbus-derived Stem Cells for Prevention of Postoperative Corneal Haze

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ClinicalTrials.gov Identifier: NCT03295292
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Vivek Singh, L.V. Prasad Eye Institute

Tracking Information
First Submitted Date  ICMJE August 19, 2017
First Posted Date  ICMJE September 27, 2017
Last Update Posted Date February 26, 2019
Actual Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2017)
Maintenance of pre-operative best-spectacle corrected visual acuity [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03295292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2017)
Efficacy in reducing corneal light scatter using Scheimpflug imaging [ Time Frame: 1 month ]
Efficacy in reducing corneal light scatter using Scheimpflug imaging at 1 month by: Objective quantification of the amount of light scattering using densitometry analysis function in Oculus Pentacam (OCULUS Optikgeräte GmbH). • All routine clinical and imaging protocols performed for patients undergoing PTK/PRK and CXL will be diligently followed.
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 Limbus-derived Stem Cells for Prevention of Postoperative Corneal Haze
Official Title  ICMJE Pilot Clinical Trial to Assess the Safety of Limbus-derived Corneal Stem Cells in Prevention of Corneal Haze After Photo Therapeutic/Refractive Keratectomy (PTK/ PRK) and Collagen Cross Linking (CXL)
Brief Summary This is a investigator-initiated pilot clinical trial to ascertain the safety and efficacy of application of ex-vivo cultivated limbal stem cells in human eyes for treating Corneal Haze after Photo-Therapeutic/Refractive Keratectomy (PTK/ PRK) and Collagen Cross Linking (CXL). Instead of using adjunctive medical therapy like application of MMC (Mitomycin), a technique of cell delivery with fibrin sealant can be used. These cells are harvested from therapeutically accepted and serologically tested cadaveric corneas. The isolated limbal epithelial and mesenchymal or stromal cell suspension will then be cultured in CGMP laboratories and be tested for sterlity. These cells have also been shown to be effective in treating haze in laser refractive surgery in an animal model. Our initial experience of using these cells in a previous clinical trial showed that they were effective in preventing corneal haze in patients with burns and ulcers.
Detailed Description In this pilot clinical trial, patients undergoing Photo Therapeutic/Refractive Keratectomy (PTK/ PRK) and Collagen Cross Linking (CXL), will be given human Limbus-derived Corneal Stem cells to assess the safety of these cells. Cells will be cultivated in a cGMP laboratory using standardized culture technique; from the limbal rims of cadaveric corneoscleral donor tissues that are therapeutically accepted and serologically tested. 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. A mixture of limbal epithelial cells and limbal stromal cells obtained from these cultures will be used in surgical procedures in a ratio of 2:1, after all the sterility checks. Mixed suspension of the limbal epithelial and the stromal cells at a concentration of 50000 cells/uL diluted in the thrombin component of fibrin sealant (TISEEL, Baxter) will be applied. The primary outcome measure is safety of this treatment and the secondary outcome measure is their efficacy that will be assessed at 1 month time points by (1) Clinical photography using a standard method where multiple blinded observers will grade the clinically apparent change in haze and (2) Objective quantification of the amount of light scattering using densitometry analysis function in Oculus Pentacam (OCULUS Optikgeräte GmbH).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Corneal Scars and Opacities
Intervention  ICMJE
  • Biological: Stem cells
    Mixture of limbus derived corneal epithelial cells and limbus derived corneal stromal cells in a ratio of 2:1, at a concentration of 50000 cells/uL diluted in fibrin sealant
  • Other: Vehicle
    50uL of commercially available fibrin sealant (Baxter, TISEEL)
Study Arms  ICMJE
  • Sham Comparator: Standard Surgery with Vehicle
    After the standard surgical procedure (PRK/PTK or CXL), patients will receive 50uL Fibrin Sealant (sham) without cells.
    Intervention: Other: Vehicle
  • Experimental: Standard Surgery with Stem Cells
    After the standard surgical procedure (PRK/PTK or CXL), patients will receive 50uL of a mixture of limbus derived corneal epithelial cells and limbus derived corneal stromal cells in a ratio of 2:1, at a concentration of 50000 cells/uL diluted in the thrombin component of Fibrin Sealant (TISEEL, Baxter).
    Interventions:
    • Biological: Stem cells
    • Other: Vehicle
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: September 21, 2017)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients between20 to 40 years of age
  • Meeting standard selection criteria for bilateral PTK/PRK or CXL
  • No systemic diseases
  • Eligible to give informed consent
  • No other ocular co-existing pathologies

Exclusion Criteria:

  • Undergoing surgery in only one eye
  • Grossly asymmetric pathology
  • Refusal to give informed consent
  • Not agreeable or uncooperative for corneal imaging
  • Unlikely to come for follow-up for 1 month
  • International and out-station patients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sayan Basu, MBBS MS +9140 3061 2625 ext 2625 sayanbasu@lvpei.org
Contact: Pravin K Vaddavalli, MBBS MS +91 40 3061 2626 ext 2626 pravin@lvpei.org
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03295292
Other Study ID Numbers  ICMJE LEC 07-17-068
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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 Institute
Principal Investigator: Vivek Singh, MSc PhD LV Prasad Eye Institute
Principal Investigator: Jagadesh C Reddy, MBBS MD LV Prasad Eye Institute
Principal Investigator: Pratik Gogri, MBBS MS LV Prasad Eye Institute
PRS Account L.V. Prasad Eye Institute
Verification Date February 2019

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