Feasibility and Safety of Human Bone Marrow-derived Mesenchymal Stem Cells by Intravitreal Injection in Patients With Retinitis Pigmentosa
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ClinicalTrials.gov Identifier: NCT01531348 |
Recruitment Status : Unknown
Verified August 2017 by La-ongsri Atchaneeyasakul, Mahidol University.
Recruitment status was: Enrolling by invitation
First Posted : February 10, 2012
Last Update Posted : August 29, 2017
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Condition or disease | Intervention/treatment | Phase |
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Retinitis Pigmentosa | Other: BM-MSC | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Feasibility and Safety of Adult Human Bone Marrow-Derived Mesenchymal Stem Cells by Intravitreal Injection in Patients With Retinitis Pigmentosa |
Study Start Date : | February 2012 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: BM-MSC
Bone marrow-derived mesenchymal stem cells 1 million cells in balanced salt solution 100 microlitres will be injected into the vitreous cavity.
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Other: BM-MSC
Bone marrow-derived mesenchymal stem cells 1 million cells in balanced salt solution 100 microlitres will be injected into the vitreous cavity. |
- Change from baseline in laser flare and cell measurements [ Time Frame: up to 12 months ]
- Change from baseline in visual function tests [ Time Frame: up to 12 months ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Retinitis pigmentosa patients diagnosed by ophthalmologists
- Age 18-65 years old
- Central visual field less than or equal to 20 degrees
- Best corrected visual acuity less than 6/120 by Snellen visual acuity chart
- Electroretinogram nonrecordable or the amplitudes were less than 25% of normal
Exclusion Criteria:
- Other eye conditions that could mask the interpretation of the results
- Unable to return for follow up
- Underlying diseases including asthma, heart failure, myocardial infarction, liver failure, renal failure
- Pregnant and lactating women

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): NCT01531348
Thailand | |
Siriraj Hospital Mahidol University | |
Bangkoknoi, Bangkok, Thailand, 10700 |
Principal Investigator: | La-ongsri Atchaneeyasakul, MD | Siriraj Hospital |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | La-ongsri Atchaneeyasakul, Professor, Mahidol University |
ClinicalTrials.gov Identifier: | NCT01531348 |
Other Study ID Numbers: |
RP-001 |
First Posted: | February 10, 2012 Key Record Dates |
Last Update Posted: | August 29, 2017 |
Last Verified: | August 2017 |
Retinitis pigmentosa Bone marrow-derived mesenchymal stem cells Intravitreal injection |
Retinitis Retinitis Pigmentosa Retinal Diseases Eye Diseases |
Eye Diseases, Hereditary Retinal Dystrophies Retinal Degeneration Genetic Diseases, Inborn |