MSC-Exos Promote Healing of MHs (MSCs)

T

Tianjin Medical University

Status and phase

Unknown
Early Phase 1

Conditions

Macular Holes

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03437759
2015KY-05

Details and patient eligibility

About

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.

Full description

Based on the purpose and hypothesis,the participants with large and longstanding idiopathic MHs underwent vitrectomy, internal limiting membrane peeling, MSC or MSC-Exo intravitreal injection, and heavy silicon oil, air, 20% SF6, or 14% C3F8 tamponade. MSCs were isolated from human umbilical cord, and MSC-Exos were isolated from supernatants of MSCs via sequential ultracentrifugation. At the time of study enrollment, as well as physical examinations, best-corrected visual acuity (BCVA) and intraocular pressure will be measured and fundoscopy be performed. All diagnoses of MH are going to confirmed via spectral-domain optical coherence tomography (OCT), and the minimum linear diameter (MLD) of each MH will be measured parallel to the retinal pigment epithelium.The participants are going to be followed up for at least 6 months via BCVA measurement, fundoscopy, OCT, and physical examinations.

Enrollment

44 estimated patients

Sex

All

Ages

Under 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

Experimental group
Experimental group
Description:
Our intervention is to add treatment of exosomes derived from mesenchymal stem cells (MSC-Exo) after pars plana vitrectomy(PPV) and ILM peeling.
Treatment:
Biological: exosomes derived from mesenchymal stem cells (MSC-Exo)
Control group
No Intervention group
Description:
Control group that receives treatment of only pars plana vitrectomy(PPV) and ILM peeling.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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