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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 : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
Vivek Singh, L.V. Prasad Eye Institute

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.

Condition or disease Intervention/treatment Phase
Corneal Scars and Opacities Biological: Stem cells Other: Vehicle Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Sham Comparator: Standard Surgery with Vehicle
After the standard surgical procedure (PRK/PTK or CXL), patients will receive 50uL Fibrin Sealant (sham) without cells.
Other: Vehicle
50uL of commercially available fibrin sealant (Baxter, TISEEL)

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).
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)




Primary Outcome Measures :
  1. Maintenance of pre-operative best-spectacle corrected visual acuity [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03295292


Contacts
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

Locations
India
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, Msc PhD    +9140 3061 2286 ext 2286    viveksingh@lvpei.org   
Sponsors and Collaborators
L.V. Prasad Eye Institute
Investigators
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

Publications of Results:
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, Prinicipal Investigator, L.V. Prasad Eye Institute
ClinicalTrials.gov Identifier: NCT03295292     History of Changes
Other Study ID Numbers: LEC 07-17-068
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vivek Singh, L.V. Prasad Eye Institute:
Phototherapeutic Keratectomy (PTK)
photorefractive Keratectomy (PRK)
Collagen Cross-linking (CXL)
Stem Cell Therapy

Additional relevant MeSH terms:
Craniocerebral Trauma
Corneal Opacity
Corneal Injuries
Corneal Diseases
Eye Diseases
Eye Injuries
Facial Injuries
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Fibrin Tissue Adhesive
Hemostatics
Coagulants