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Mesenchymal Stromal Cell Secretome

High dose of allogenic MSC drops for Corneas (MSCSecretome Trial)

Phase < 1

Recruiting

Led By Elmer Y Tu, MD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A stable ocular surface with no objective clinical evidence of significant (> 50%) improvement/worsening of the epithelial disease in the last 30 days

Chronic corneal epithelial disease with fluorescein staining score ≥ 6 by NEI grading scale

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, days 7, 14, 28, 56, 90

Awards & highlights

MSCSecretome Trial Summary

"This trial will test the safety and maximum tolerated dose of eye drops containing MSC Secretome over time. The study will take place at the Illinois Eye and Ear Infirmary at the University of Illinois at

Who is the study for?

This trial is for adults over 18 with chronic corneal epithelial disease, evidenced by a specific score on the NEI grading scale and reduced corneal sensation. Participants should have stable eye conditions without significant changes in the past month and must not have responded to standard non-surgical treatments.Check my eligibility

What is being tested?

The study tests MSC Secretome eye drops' safety and maximum tolerated dose for ocular surface diseases. It's a dose-escalation study at Illinois Eye and Ear Infirmary using advanced imaging, sensitivity measurements, and patient feedback on comfort.See study design

What are the potential side effects?

While the trial primarily assesses safety, potential side effects may include discomfort or irritation in the eyes, allergic reactions to components of the eye drops, or possible worsening of ocular symptoms.

MSCSecretome Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My eye condition has been stable without major changes for the last month.

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I have a severe eye surface condition confirmed by a specific test.

MSCSecretome Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, days 7, 14, 28, 56, 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, days 7, 14, 28, 56, 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, days 7, 14, 28, 56, 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Epithelial Status Assessment

Secondary outcome measures

Corneal Epithelial thickness

Corneal Scarring / Haze

Durability of Corneal Epithelial Status Improvement

+3 more

MSCSecretome Trial Design

3Treatment groups

Active Control

Group I: High dose of allogenic MSC dropsActive Control1 Intervention

Escalating doses of allogenic MSC eye drops will be assigned at the high dose level.

Group II: Medium dose of allogenic MSC dropsActive Control1 Intervention

Escalating doses of allogenic MSC eye drops will be assigned at the medium dose level.

Group III: Low dose of allogenic MSC dropsActive Control1 Intervention

Escalating doses of allogenic MSC eye drops will be assigned at the lowest dose level.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Eye Institute (NEI)NIH

547 Previous Clinical Trials

1,402,139 Total Patients Enrolled

University of Illinois at ChicagoLead Sponsor

609 Previous Clinical Trials

1,559,291 Total Patients Enrolled

1 Trials studying Corneas

8 Patients Enrolled for Corneas

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,832 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently opportunities for individuals to enroll in this research study?

"As documented on clinicaltrials.gov, patient enrollment is actively ongoing for this research. The trial was initially listed on 1/24/2024 and the most recent update was made on 2/20/2024."

Answered by AI

What is the current number of participants enrolled in this clinical trial?

"Affirmative. The details on clinicaltrials.gov affirm that this research study is presently enrolling volunteers. It was initially listed on January 24, 2024, and the latest update was made on February 20, 2024. The aim is to recruit a total of 18 participants from one designated site."

Answered by AI

Recent research and studies

Molecular TherapyJournal

Mesenchymal Stem/stromal Cells (mscs): Role as Guardians of Inflammation

Prockop, Darwin J, and Joo Youn Oh. 2012. “Mesenchymal Stem/stromal Cells (mscs): Role as Guardians of Inflammation”. Molecular Therapy. Elsevier BV. doi:10.1038/mt.2011.211.

Journal of Biomedical ScienceJournal

Human Mesenchymal Stem Cells (mscs) for Treatment Towards Immune- and Inflammation-mediated Diseases: Review of Current Clinical Trials

Wang, Li-Tzu, Chiao-Hsuan Ting, Men-Luh Yen, Ko-Jiunn Liu, Huey-Kang Sytwu, Kenneth K. Wu, and B. Linju Yen. 2016. “Human Mesenchymal Stem Cells (mscs) for Treatment Towards Immune- and Inflammation-mediated Diseases: Review of Current Clinical Trials”. Journal of Biomedical Science. Springer Science and Business Media LLC. doi:10.1186/s12929-016-0289-5.

Stem Cells InternationalJournal

Control of Cross Talk Between Angiogenesis and Inflammation by Mesenchymal Stem Cells for the Treatment of Ocular Surface Diseases

Li, Fei, and Shao-zhen Zhao. 2016. “Control of Cross Talk Between Angiogenesis and Inflammation by Mesenchymal Stem Cells for the Treatment of Ocular Surface Diseases”. Stem Cells International. Hindawi Limited. doi:10.1155/2016/7961816.

Stem CellsJournal