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NCT04932629
A Proof of Concept Study to Evaluate the Clinical Safety and Efficacy of Ex-vivo Cultivated Allogenic Limbal Stem Cell Transplantation for Treatment of Superficial Corneal Pathologies".
EARLY_PHASE1 trial testing Ex-vivo cultivated Allogeneic limbal stromal stem cells in Corneal Scars and Opacities in 20 participants. Status unknown.
1 December 2021
Quick facts
| Lead sponsor | L.V. Prasad Eye Institute |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 July 2021 |
| Primary completion | 1 December 2021 |
| Estimated completion | 1 January 2023 |
Drugs / interventions tested
- Ex-vivo cultivated Allogeneic limbal stromal stem cells — full drug profile →
Conditions studied
- Corneal Scars and Opacities — all drugs for Corneal Scars and Opacities →
Sponsor
L.V. Prasad Eye Institute
Who can join
Adults 18 to 60, any sex, with Corneal Scars and Opacities. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Measurement of any ocular or systemic adverse effects
Time frame: Day 90 post-surgery
The primary outcome measure of this study is to note any ocular or systemic adverse effects
Sponsor's own description
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
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Therapeutic Strategies for Restoring Perturbed Corneal Epithelial Homeostasis in Limbal Stem Cell Deficiency: Current Trends and Future Directions.
Masood F, Chang JH, Akbar A, Song A, et al · · 2022 · cited 26× · PMID 36291115 · DOI 10.3390/cells11203247 -
Regenerative treatment of ophthalmic diseases with stem cells: Principles, progress, and challenges.
Niu Y, Ji J, Yao K, Fu Q. · · 2024 · cited 25× · PMID 38586868 · DOI 10.1016/j.aopr.2024.02.001 -
Regenerative Therapy for Corneal Scarring Disorders.
Chandran C, Santra M, Rubin E, Geary ML, et al · · 2024 · cited 17× · PMID 38540264 · DOI 10.3390/biomedicines12030649 -
Recent Advancements in Molecular Therapeutics for Corneal Scar Treatment.
Ghosh A, Singh VK, Singh V, Basu S, et al · · 2022 · cited 14× · PMID 36291182 · DOI 10.3390/cells11203310 -
Tackling visual impairment: emerging avenues in ophthalmology.
Lin F, Su Y, Zhao C, Akter F, et al · · 2025 · cited 4× · PMID 40357281 · DOI 10.3389/fmed.2025.1567159 -
Advances in Regulatory Strategies of Differentiating Stem Cells towards Keratocytes.
Zhang A, Zhang W, Backman LJ, Chen J. · · 2022 · cited 4× · PMID 35140792 · DOI 10.1155/2022/5403995 -
Applications of Modern Cell Therapies: The Latest Data in Ophthalmology.
Iliadis I, Pechnikova NA, Poimenidou M, Almaliotis DD, et al · · 2025 · PMID 41157282 · DOI 10.3390/life15101610
Verify or expand the search:
- PubMed search for NCT04932629
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other L.V. Prasad Eye Institute trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04932629 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by L.V. Prasad Eye Institute
- Last refreshed: 12 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04932629.
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