MSC-Exos Promote Healing of MHs

NCT03437759 | Unknown Early Phase 1 DMC

• 1 other identifier: 2015KY-05
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To assess the safety and efficacy of mesenchymal stem cells (MSCs) and MSC-derived exosomes (MSC-Exos) for promoting healing of large and refractory macular holes (MHs). Hypothesis: MSC and MSC-Exo therapy may promote functional and anatomic recovery from MH. MSC-Exo therapy may be a useful and safe method for improving visual outcomes of surgery for refractory MHs.

Conditions

Macular Holes

Keywords

macular hole (MH); exosomes; mesenchymal stem cells; pars plana vitrectomy

Outcome Measures

Primary Outcomes (1)

• Macular holes closure

  Minimum linear diameter (MLD) of the hole measured by OCT

  baseline to 24 weeks post-surgery

Secondary Outcomes (1)

• Best corrected visual acuity(BCVA)

  baseline to 24 weeks post-surgery

Study Arms (2)

Experimental group

EXPERIMENTAL

Our intervention is to add treatment of exosomes derived from mesenchymal stem cells (MSC-Exo) after pars plana vitrectomy(PPV) and ILM peeling.

Biological: exosomes derived from mesenchymal stem cells (MSC-Exo)

Control group

NO INTERVENTION

Control group that receives treatment of only pars plana vitrectomy(PPV) and ILM peeling.

Interventions

exosomes derived from mesenchymal stem cells (MSC-Exo) BIOLOGICAL

After air-liquid exchange, 50μg or 20μg MSC-Exo in 10μl PBS was dripped into vitreous cavity around MH, leaving 20% SF6 or air as tamponade .

Experimental group

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of idiopathic macular hole whose diameter is greater than 400 microns

You may not qualify if:

• Only one functional eye
• In other clinical trials.
• Other diseases which can affect visual acuity, such as cataract, diabetic retinopathy, glaucoma, corneal diseases, etc.
• Eye had undergone vitrectomy or scleral buckling, cataract surgery, Nd:YAG laser less than one month ago.
• Contralateral eye has poor prognosis than the study eye.
• Idiopathic or autoimmune uveitis history.
• Aphakic eye
• Physical condition is poor that can not keep prone position.
• Secondary macular lesions
• The equivalent spherical diopter of the study eye before any refractive correction or cataract surgery, which is greater than 6.0d or above 26mm of the ocular axis of the study eye.
• Intraocular pressure is higher than 25mmHg
• Within ocular inflammation, such as eye blepharitis, scleritis, keratitis and conjunctivitis.
• Systemic condition is poor, such as the poor control of diabetes and hypertension, myocardial infarction, cerebrovascular accident, renal failure and so on,and the researchers assessed those who are unable to complete the trail.

Sponsors & Collaborators

• Tianjin Medical University: lead

Study Sites (1)

Tianjin Medical University Hospital

Tianjin, China

Location

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MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Rong X Li, MD,PhD

  Tianjin Medical University Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 19, 2018
• Study Start: March 1, 2017
• Primary Completion: May 30, 2018
• Study Completion: December 30, 2021
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)