MSC-Exos Promote Healing of MHs

Macular Holes Clinical Trial

— MSCs  

Official title:

Mesenchymal Stem Cells Derived Exosomes Promote Healing of Large and Refractory Macular Holes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03437759
• Other study ID #: 2015KY-05
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: March 1, 2017
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2021
• Source: Tianjin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: December 30, 2021
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

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 .

Locations

Country	Name	City	State
China	Tianjin Medical University Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University

Country where clinical trial is conducted

China, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular holes closure	Minimum linear diameter (MLD) of the hole measured by OCT	baseline to 24 weeks post-surgery
Secondary	Best corrected visual acuity(BCVA)	BCVA using a Landolt C acuity chart method	baseline to 24 weeks post-surgery