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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 : 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

February 6, 2012
February 10, 2012
August 29, 2017
February 2012
December 2020   (Final data collection date for primary outcome measure)
Change from baseline in laser flare and cell measurements [ Time Frame: up to 12 months ]
Same as current
Complete list of historical versions of study NCT01531348 on ClinicalTrials.gov Archive Site
Change from baseline in visual function tests [ Time Frame: up to 12 months ]
Same as current
Not Provided
Not Provided
 
Feasibility and Safety of Human Bone Marrow-derived Mesenchymal Stem Cells by Intravitreal Injection in Patients With Retinitis Pigmentosa
Feasibility and Safety of Adult Human Bone Marrow-Derived Mesenchymal Stem Cells by Intravitreal Injection in Patients With Retinitis Pigmentosa
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.
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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Retinitis Pigmentosa
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.
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.
Intervention: Other: BM-MSC

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
10
Same as current
December 2020
December 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT01531348
RP-001
Yes
Not Provided
Not Provided
La-ongsri Atchaneeyasakul, Mahidol University
Mahidol University
Ministry of Health, Thailand
Principal Investigator: La-ongsri Atchaneeyasakul, MD Siriraj Hospital
Mahidol University
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP