To Evaluate the Clinical Safety and Efficacy of Limbal Stem Cell for Treatment of Superficial Corneal Pathologies".

NCT04932629 | Unknown Early Phase 1 DMC

• 1 other identifier: HERF-SSC-SCP-01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study proposes to investigate the transplantation of ex-vivo cultivated allogenic limbal stromal cells for the treatment of the corneal pathologies. The limbus is an ideal source as the stem cells are numerous and located very superficially in the tissue (17). Pre-clinical work suggests human corneal stromal stem cells can be isolated from the cadaveric tissues, cultivated in conditions suitable for cell based therapy and used to prevent fibrosis in a murine model of corneal stromal scarring. Further, these cells are able to successfully engraft, differentiate, and mediate wound healing in the corneal stroma such that the tissue remains healthy, free of fibrotic tissue, and optically transparent. The clinical implications of these findings are substantial in that it represents the potential to lessen the burden on donor tissue necessary for corneal allografts by using cultured cells to regenerate tissue. We foresee the ability of a clinician to and grow and expand the cells in number and after surgically removing the scar tissue from the wounded eye, apply the cultured limbal stem cells to regenerate healthy, transparent tissue.

Conditions

Corneal Scars and Opacities

Outcome Measures

Primary Outcomes (1)

• Measurement of any ocular or systemic adverse effects

  The primary outcome measure of this study is to note any ocular or systemic adverse effects

  Day 90 post-surgery

Secondary Outcomes (2)

• Measurement of Visual improvement

  Day 720 post surgery

• Change in Corneal light scattering

  Day 720 post surgery

Study Arms (1)

Experimental Group

EXPERIMENTAL

The eligible patients will undergo corneal transplant surgery, when the central corneal epithelium will be removed using a surgical sponge. 0.1ml of stromal cells in a concentration of 0.5x106 cells/µl diluted in the thrombin component of fibrin glue (TISEEL, Baxter) will be applied to the debrided corneal stroma.

Biological: Ex-vivo cultivated Allogeneic limbal stromal stem cells

Interventions

Ex-vivo cultivated Allogeneic limbal stromal stem cells BIOLOGICAL

n this prospective intervention study patients with unilateral superficial corneal scars will undergo a surgical procedure and in the second procedure, the eligible patients will undergo corneal transplant surgery, when the central corneal epithelium will be removed using a surgical sponge. 0.1ml of stromal cells in a concentration of 0.5x10\*6 cells/µl 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 30, Day 90, Day 180 and Day 360 and 720 Days post-surgery

Experimental Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female participants who are ≥18 and ≤ 60 years of age.
• Patients having unilateral superficial corneal pathologies (defined as involving the anterior 200µM of the corneal stroma on ASOCT imaging)
• Corneal burns, ulcers and scars
• No prior history of corneal transplantation
• No ongoing and other active ocular pathology
• Candidate for stem cell transplant
• No severe pathological and psychological conditions that might interfere with the patient's participation in the study
• Able to provide written and audio-visual informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice

You may not qualify if:

• Bilateral corneal disease,
• Corneal scars with limbal dysfunction (clinically defined as absent limbal palisades or conjunctivalization of the cornea)
• Ocular surface disease including dry eye disease (defined as a Schirmer's test of less than 10mm at 5 minutes),
• Unknown etiology, post-herpetic eye disease or eyes with active intra-ocular inflammation,
• Children (\<18 years of age),
• Less than 3 months after documented clinical resolution of acute disease
• Inability/refusal to give written informed consent
• Undergo any of the anterior segment imaging tests.
• Patient should have not participated in another clinical study within 30 days of their enrolment on this study.
• History or evidence of cardiac disease: congestive heart failure; New York Heart Association (NYHA) class 2 or greater (see Appendix 6); active coronary artery disease; unstable angina, cardiac arrhythmias requiring anti-arrhythmic therapy, atrio-ventricular block of second or third degree, or uncontrolled hypertension, patients with recent (less than 6 months) myocardial infarction (MI) or coronary revascularization.
• Pregnant and lactating patients, positive urine pregnancy test in women of childbearing potential
• Reproductive age patients not practicing effective and adequate birth control measures
• Previous participation in this study

Sponsors & Collaborators

• L.V. Prasad Eye Institute: lead

Related Publications (3)

• 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: 25504883 BACKGROUND

• 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

• Funderburgh, J., Basu, S., Damala, M., Tavakkoli, F., Sangwan, V., & Singh, V. (2018). Limbal stromal stem cell therapy for acute and chronic superficial corneal pathologies: one-year outcomes. Investigative Ophthalmology & Visual Science, 59(9), 3455-3455

  RESULT

MeSH Terms

Conditions

Corneal Injuries

Condition Hierarchy (Ancestors)

Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Corneal Diseases; Eye Diseases; Wounds and Injuries

Study Officials

• Dr.Vivek Singh, PhD

  LV Prasad Eye Institute (Hyderabad Eye Research Foundation)

  PRINCIPAL INVESTIGATOR

• Dr.Sayan Basu, MBBS.MS

  LV Prasad Eye Institute (Hyderabad Eye Research Foundation)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr.Sayan Basu, MBBS,MS

CONTACT

040-68102534; sayanbasu@lvpei.org

Dr.Vivek Singh, PhD

CONTACT

040-68102286; viveksingh@lvpei.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: June 21, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2023
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share