Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03437759
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : September 17, 2019
Sponsor:
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.

Layout table for study information
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, 2019

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 ClinicalTrials.gov identifier (NCT number): NCT03437759


Contacts
Layout table for location contacts
Contact: Jun X Ren, MD 13902067301 zlrxjrsy@126.com

Locations
Layout table for location information
China
Tianjin Medical University Hospital Recruiting
Tianjin, China
Contact: Xinjun Ren, MD    13902067301    20502051@qq.com   
Sponsors and Collaborators
Tianjin Medical University
Investigators
Layout table for investigator information
Principal Investigator: Rong X Li, MD,PhD Tianjin Medical University Eye Hospital

Publications of Results:

Layout table for additonal information
Responsible Party: Xiaomin Zhang, Principal Investigator, Tianjin Medical University Eye Hospital
ClinicalTrials.gov Identifier: NCT03437759     History of Changes
Other Study ID Numbers: 2015KY-05
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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)
exosomes
mesenchymal stem cells
pars plana vitrectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Perforations
Retinal Diseases
Eye Diseases