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Macular HolesEarly Phase 1MSCsNCT03437759

MSC-Exos Promote Healing of MHs

A Early Phase 1 study testing exosomes derived from mesenchymal stem cells (MSC-Exo) in people with Macular Holes, run by Tianjin Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 80 yearsHealthy volunteers can take part
Conditions the study is for
Macular Holes
What is being tested?
exosomes derived from mesenchymal stem cells (MSC-Exo)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
1 Mar 2017to 30 Dec 2021
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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 locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Medical University Hospital

    Tianjin

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Macular Holes
Being tested
exosomes derived from mesenchymal stem cells (MSC-Exo)
Keywords
macular hole (MH), exosomes, mesenchymal stem cells, pars plana vitrectomy
Medical subject headings
Retinal Perforations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 .

Study groups in NCT03437759
Study groupRoleWhat they receive
Experimental groupExperimentalOur intervention is to add treatment of exosomes derived from mesenchymal stem cells (MSC-Exo) after pars plana vitrectomy(PPV) and ILM peeling.
Receives: Biological: exosomes derived from mesenchymal stem cells (MSC-Exo)
Control groupNo interventionControl group that receives treatment of only pars plana vitrectomy(PPV) and ILM peeling.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Macular holes closure

    Minimum linear diameter (MLD) of the hole measured by OCT

    Measured: baseline to 24 weeks post-surgery

Secondary outcomes (1)

  1. Best corrected visual acuity(BCVA)

    BCVA using a Landolt C acuity chart method

    Measured: baseline to 24 weeks post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start1 Mar 2017
  3. Primary completion30 May 2018
  4. Study completion30 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03437759
Sponsor's protocol ID
2015KY-05
Acronym
MSCs
Status last verified
Apr 2021
First submitted
23 Jan 2018
Last updated
6 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rahmani B, Tielsch JM, Katz J, Gottsch J, Quigley H, Javitt J, Sommer A. The cause-specific prevalence of visual impairment in an urban population. The Baltimore Eye Survey. Ophthalmology. 1996 Nov;103(11):1721-6. doi: 10.1016/s0161-6420(96)30435-1.

    PubMed 8942862

  • Kelly NE, Wendel RT. Vitreous surgery for idiopathic macular holes. Results of a pilot study. Arch Ophthalmol. 1991 May;109(5):654-9. doi: 10.1001/archopht.1991.01080050068031.

    PubMed 2025167

  • Michalewska Z, Michalewski J, Cisiecki S, Adelman R, Nawrocki J. Correlation between foveal structure and visual outcome following macular hole surgery: a spectral optical coherence tomography study. Graefes Arch Clin Exp Ophthalmol. 2008 Jun;246(6):823-30. doi: 10.1007/s00417-007-0764-5. Epub 2008 Apr 2.

    PubMed 18386040

  • Ezra E, Gregor ZJ; Morfields Macular Hole Study Ggroup Report No. 1. Surgery for idiopathic full-thickness macular hole: two-year results of a randomized clinical trial comparing natural history, vitrectomy, and vitrectomy plus autologous serum: Morfields Macular Hole Study Group RAeport no. 1. Arch Ophthalmol. 2004 Feb;122(2):224-36. doi: 10.1001/archopht.122.2.224.

    PubMed 14769600

  • Suda K, Hangai M, Yoshimura N. Axial length and outcomes of macular hole surgery assessed by spectral-domain optical coherence tomography. Am J Ophthalmol. 2011 Jan;151(1):118-127.e1. doi: 10.1016/j.ajo.2010.07.007.

    PubMed 20970769

  • Del Priore LV, Kaplan HJ, Bonham RD. Laser photocoagulation and fluid-gas exchange for recurrent macular hole. Retina. 1994;14(4):381-2. doi: 10.1097/00006982-199414040-00018. No abstract available.

    PubMed 7817035

  • Johnson RN, McDonald HR, Schatz H, Ai E. Outpatient postoperative fluid-gas exchange after early failed vitrectomy surgery for macular hole. Ophthalmology. 1997 Dec;104(12):2009-13. doi: 10.1016/s0161-6420(97)30064-5.

    PubMed 9400759

  • Ohana E, Blumenkranz MS. Treatment of reopened macular hole after vitrectomy by laser and outpatient fluid-gas exchange. Ophthalmology. 1998 Aug;105(8):1398-403. doi: 10.1016/S0161-6420(98)98019-8.

    PubMed 9709749

  • Liggett PE, Skolik DS, Horio B, Saito Y, Alfaro V, Mieler W. Human autologous serum for the treatment of full-thickness macular holes. A preliminary study. Ophthalmology. 1995 Jul;102(7):1071-6. doi: 10.1016/s0161-6420(95)30909-8.

    PubMed 9121755

  • Wells JA, Gregor ZJ. Surgical treatment of full-thickness macular holes using autologous serum. Eye (Lond). 1996;10 ( Pt 5):593-9. doi: 10.1038/eye.1996.136.

    PubMed 8977788

  • Kim JY, Kwon OW. VITRECTOMY FOR REFRACTORY MACULAR HOLE. Retin Cases Brief Rep. 2015 Fall;9(4):265-8. doi: 10.1097/ICB.0000000000000183.

    PubMed 26398430

  • Kozy DW, Maberley AL. Closure of persistent macular holes with human recombinant transforming growth factor-beta 2. Can J Ophthalmol. 1996 Jun;31(4):179-82.

    PubMed 8804755

  • Rizzo S, Belting C, Genovesi-Ebert F, Cresti F, Vento A, Martini R. Successful treatment of persistent macular holes using "heavy silicone oil" as intraocular tamponade. Retina. 2006 Oct;26(8):905-8. doi: 10.1097/01.iae.0000250006.76155.3d.

    PubMed 17031291

  • Cillino S, Cillino G, Ferraro LL, Casuccio A. TREATMENT OF PERSISTENTLY OPEN MACULAR HOLES WITH HEAVY SILICONE OIL (DENSIRON 68) VERSUS C2F6. A PROSPECTIVE RANDOMIZED STUDY. Retina. 2016 Apr;36(4):688-94. doi: 10.1097/IAE.0000000000000781.

    PubMed 26418444

  • Michalewska Z, Michalewski J, Adelman RA, Nawrocki J. Inverted internal limiting membrane flap technique for large macular holes. Ophthalmology. 2010 Oct;117(10):2018-25. doi: 10.1016/j.ophtha.2010.02.011. Epub 2010 Jun 11.

    PubMed 20541263

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing exosomes derived from mesenchymal stem cells (MSC-Exo) in people with Macular Holes, run by Tianjin Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Macular holes closure (time frame: baseline to 24 weeks post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03437759, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.

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