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Feasibility and Safety of Human Bone Marrow-derived Mesenchymal Stem Cells by Intravitreal Injection in Patients With Retinitis Pigmentosa

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01531348
Recruitment Status : Enrolling by invitation
First Posted : February 10, 2012
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
Ministry of Health, Thailand
Information provided by (Responsible Party):
La-ongsri Atchaneeyasakul, Mahidol University

Study Description
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Brief Summary:
The purpose of this study is to determine the feasibility and safety of adult human bone marrow-derived mesenchymal stem cells by intravitreal injection in patients with retinitis pigmentosa.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Other: BM-MSC Phase 1

Detailed Description:
Retinitis pigmentosa (RP) is an inherited disorder of the photoreceptor cells in the retina. Patients may lose vision since they were young or later in life. Currently, there are more than 60 genes identified as the cause of this condition, one of which, RPE65, has been studied in several gene therapy trials for Leber congenital amaurosis with promising results. Another treatment approach for RP is stem cell therapy. Studies in animal models of RP have shown that subretinal injection of bone marrow-derived mesenchymal stem cells may delay degenerative changes of photoreceptor cells.
Study Design
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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

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Arms and Interventions
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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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in laser flare and cell measurements [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  1. Change from baseline in visual function tests [ Time Frame: up to 12 months ]

Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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): NCT01531348


Locations
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Thailand
Siriraj Hospital Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Ministry of Health, Thailand
Investigators
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Principal Investigator: La-ongsri Atchaneeyasakul, MD Siriraj Hospital
More Information
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Publications of Results:

Other Publications:

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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
Keywords provided by La-ongsri Atchaneeyasakul, Mahidol University:
Retinitis pigmentosa
Bone marrow-derived mesenchymal stem cells
Intravitreal injection
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
 Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn