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MSC-Exos Promote Healing of MHs (MSCs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03437759
Recruitment Status : Active, not recruiting
First Posted : February 19, 2018
Last Update Posted : April 6, 2021
Information provided by (Responsible Party):
Xiaomin Zhang, Tianjin Medical University Eye Hospital

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.

Condition or disease Intervention/treatment Phase
Macular Holes Biological: exosomes derived from mesenchymal stem cells (MSC-Exo) Early Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cells Derived Exosomes Promote Healing of Large and Refractory Macular Holes
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : May 30, 2018
Estimated Study Completion Date : December 30, 2021

Arm Intervention/treatment
Experimental: Experimental group
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)
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 .

No Intervention: Control group
Control group that receives treatment of only pars plana vitrectomy(PPV) and ILM peeling.

Primary Outcome Measures :
  1. Macular holes closure [ Time Frame: baseline to 24 weeks post-surgery ]
    Minimum linear diameter (MLD) of the hole measured by OCT

Secondary Outcome Measures :
  1. Best corrected visual acuity(BCVA) [ Time Frame: baseline to 24 weeks post-surgery ]
    BCVA using a Landolt C acuity chart method

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  1. Only one functional eye
  2. In other clinical trials.
  3. Other diseases which can affect visual acuity, such as cataract, diabetic retinopathy, glaucoma, corneal diseases, etc.
  4. Eye had undergone vitrectomy or scleral buckling, cataract surgery, Nd:YAG laser less than one month ago.
  5. Contralateral eye has poor prognosis than the study eye.
  6. Idiopathic or autoimmune uveitis history.
  7. Aphakic eye
  8. Physical condition is poor that can not keep prone position.
  9. Secondary macular lesions
  10. 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.
  11. Intraocular pressure is higher than 25mmHg
  12. Within ocular inflammation, such as eye blepharitis, scleritis, keratitis and conjunctivitis.
  13. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03437759

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Tianjin Medical University Hospital
Tianjin, China
Sponsors and Collaborators
Tianjin Medical University
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Principal Investigator: Rong X Li, MD,PhD Tianjin Medical University Eye Hospital
Publications of Results:

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Responsible Party: Xiaomin Zhang, Principal Investigator, Tianjin Medical University Eye Hospital Identifier: NCT03437759    
Other Study ID Numbers: 2015KY-05
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaomin Zhang, Tianjin Medical University Eye Hospital:
macular hole (MH)
mesenchymal stem cells
pars plana vitrectomy
Additional relevant MeSH terms:
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Retinal Perforations
Retinal Diseases
Eye Diseases