An Early Phase 1 interventional study of exosomes derived from mesenchymal stem cells (MSC-Exo) in Macular Holes, sponsored by Tianjin Medical University. Status unknown at 1 site in China. Open to participants aged Up to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-06.
Sponsored by Tianjin Medical University · Early Phase 1, Interventional, and Treatment
Among 17 studies in Retinal Perforations with a site in China — 4 open to participants now, 6 under way, none of them phase 3. Retinal Perforations · China.
Among the 17 studies in Retinal Perforations with a site in China, this one is the 9th largest by planned enrollment of the 13 interventional ones, is one of 3 that started in 2017, is the only one in phase 1, and was the 7th registered.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's planned enrollment of 44 is below the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →4 of the 17 studies in Retinal Perforations with a site in China are open now, in 1 country. Each count lists the studies.
Of the 17 Retinal Perforations studies recruiting now, 15 (88%) set no upper age limit and 1 (6%) stop at 75 or younger; 5 take children under 18; 3 take healthy volunteers.
This study: Up to 80 Years · all sexes · healthy volunteers too.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2017.
Median enrollment 52 across the 13 interventional studies, 240 across the 4 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
1 of 17 have an industry lead sponsor. The 10 most frequent:
Tianjin Medical University is the lead sponsor of 49 studies on the registry; 30 are open to participants now.
Tianjin Medical University has 1 study filed under Retinal Perforations — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 17 studies in Retinal Perforations with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1.Clinical diagnosis of idiopathic macular hole whose diameter is greater than 400 microns
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 that receives treatment of only pars plana vitrectomy(PPV) and ILM peeling.
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 .
Macular holes closure
Minimum linear diameter (MLD) of the hole measured by OCT
Time frame: baseline to 24 weeks post-surgery
Best corrected visual acuity(BCVA)
BCVA using a Landolt C acuity chart method
Time frame: baseline to 24 weeks post-surgery
Plan to share: No
Ran from Mar 2017 to primary completion in May 2018, 14 months.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University