Stem Cells Therapy for Corneal Blindness

NCT ID: NCT02948023

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-08-31

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.

Conditions

Corneal Injuries; Corneal Burns; Corneal Scars and Opacities

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Surgical therapy

Includes the control group that fulfills the inclusion criteria

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Ex-vivo cultivated limbal stem cell pool

Intervention Type: BIOLOGICAL

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.

Interventions

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 Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

L.V. Prasad Eye Institute

OTHER

Sponsor Role: lead

Responsible Party

Vivek Singh

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sayan Basu, MBBS, MS

Role: PRINCIPAL_INVESTIGATOR

LV Prasad Eye Institiute

Vivek Singh, MSc PhD

Role: PRINCIPAL_INVESTIGATOR

LV Prasad Eye Institiute

Locations

LV Prasad Eye Institute

Hyderabad, Telangana, India

Site Status: RECRUITING

Countries

India

Central Contacts

Sayan Basu, MBBS, MS

Role: CONTACT

sayanbasu@lvpei.org

9140-30612625 ext. 2625

Vivek Singh, MSc PhD

Role: CONTACT

viveksingh@lvpei.org

9140-30612286 ext. 2286

Facility Contacts

Sayan Basu, MBBS, MS

Role: primary

sayanbasu@lvpei.org

+9140 3061 2625 ext. 2625

Vivek Singh Singh, MSc PhD

Role: backup

viveksingh@lvpei.org

+9140 3061 2286 ext. 2286

References

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.

Reference Type: RESULT

PMID: 25504883 (View on PubMed)

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

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

LVPEI-2014-1 Version 1 15Jan14

Identifier Type: -

Identifier Source: org_study_id