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Completed

NCT Number: NCT04773431

Safety Evaluation of LSCD101 Transplantation for Limbal Stem Cell Deficiency

Clinical Study Objective:

To evaluate the tolerability and safety after transplantation of LSCD101 in patients with intractable limbal stem cell deficiency

Study Method:

Subjects who finally meet the inclusion/exclusion criteria results of the subject eligibility evaluation will receive transplantation of the investigational product. Adverse drug reaction will be confirmed during 24 weeks after transplantation.

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Key information

Conditions

Limbus Corneae Limbus Corneae Insufficiency Syndrome

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CliPS

Seoul, 04168, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women aged 19 or older
  • Diagnosed with intractable limbal stem cell deficiency in single eye, with severity in which corneal neovascularization invades more than two quadrants
  • No improvement of indication by known treatment (non-surgical/surgical) method according to investigator's judgment
  • BCVA 20/40 or less at screening in the eye with the limbal stem cell deficiency
  • Voluntarily agreed to participate in this study and signed a consent form

Exclusion criteria

  • Inappropriate for harvesting limbal epithelial cells for the production of limbal epithelial cell sheet.
  • Difficulty in reconstruction of the corneal epithelium because the eye is not closed due to eyelid function problems in the eye with the limbal stem cell deficiency.
  • Severe dry eye with problem with tear secretion in both eyes (value of Schirmer I test without anesthesia < 2 mm/5 min at screening)
  • Acute ocular surface inflammation of both corneas at Visit 2
  • Malignant tumor history (except in case of no recurrence more than 5 years after surgery)
  • Uncontrolled comorbidities such as moderate to severe infections and bleeding
  • Positive for virus infection (HBV, HCV, HIV, CMV, HTLVⅠ/Ⅱ, syphilis)
  • Uncontrolled diabetes (HbA1c ≥9.0%)
  • Uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg despite taking antihypertensives at screening)
  • Uncontrolled glaucoma (IOP > 21 mmHg despite taking glaucoma medication)
  • Pregnant or lactating women
  • Women with childbearing potential, those who do not agree to contraception by medically accepted contraceptive methods during clinical trials
  • Participation in another clinical study within 4 weeks
  • Subjects judged by the investigator to be inappropriate to participate in the clinical study

Treatment and study plan

LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation

Drug

LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion.

Primary outcomes

  1. Rate of Adverse event

    Time frame: From limbal tissue collection until 24 weeks after transplantation

    Adverse event

Secondary outcomes

  1. Rate of normal/abnormal results in clinical laboratory test

    Time frame: Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation

    Comparisons between pre-/post- transplantation are summarized and presented

  2. Blood pressure(systolic/diastolic) at each visit

    Time frame: Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation

    Comparisons between pre-/post- transplantation are summarized and presented.

  3. Pulse rate at each visit

    Time frame: Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation

    Comparisons between pre-/post- transplantation are summarized and presented.

  4. Rate of normal/abnormal results in Electrocardiogram

    Time frame: Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation

    Comparisons between pre-/post- transplantation are summarized and presented.

  5. Rate of normal/abnormal results in physical examination at each visit

    Time frame: Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation

    Comparisons between pre-/post- transplantation are summarized and presented.

  6. Rate of eye infection and inflammation

    Time frame: Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation

    Eye infection and inflammation test (slit lamp microscopy)

  7. Intraocular pressure test

    Time frame: Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation

    Intraocular pressure test

Sponsors and collaborators

Lead sponsor

CliPS Co., Ltd

Industry

Registry information

Official study title

Phase I Study to Evaluate Safety of LSCD101(Cultured Autologous Limbal Epithelial Cell Sheet) Transplantation for Limbal Stem Cell Deficiency

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2021
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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