Ex-vivo Cultivated Limbal Stem Cell Transplantation for Treatment of Superficial Corneal Pathologies
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Ocular or systemic adverse effects
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female participants who are aged between 18-60 years.
- •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.
- •Eyes with otherwise normal.
排除标准
- •Active infection, proven by microbiology.
- •Unknown etiology, post-herpetic eye disease or eyes with active intra-ocular inflammation.
- •Children (<18 years of age).
- •Inability/refusal to give written informed consent or to undergo any of the anterior segment imaging tests.
研究组 & 干预措施
Standard Surgical therapy
Includes the control group that fulfills the inclusion criteria
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.
干预措施: Ex-vivo cultivated limbal stem cell pool (Biological)
结局指标
主要结局
Ocular or systemic adverse effects
时间窗: until 3months after surgery
次要结局
- Visual improvement after treatment.(until 3months after surgery)
研究者
Vivek Singh
Dr
L.V. Prasad Eye Institute
