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NCT Number: NCT01531348

Intravitreal Injection of MSCs in 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.

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Key information

Conditions

Retinitis Pigmentosa Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Retinal Degeneration Retinal Diseases Retinal Dystrophies

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Siriraj Hospital Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BM-MSC

Other

Bone marrow-derived mesenchymal stem cells 1 million cells in balanced salt solution 100 microlitres will be injected into the vitreous cavity.

Primary outcomes

  1. Change from baseline in laser flare and cell measurements

    Time frame: up to 12 months

Secondary outcomes

  1. Change from baseline in visual function tests

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Ministry of Health, Thailand

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2012
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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