Intravitreal Injection of MSCs in Retinitis Pigmentosa

Mahidol University

Status and phase

Completed

Phase 1

Conditions

Retinitis Pigmentosa

Treatments

Other: BM-MSC

Study type

Interventional

Funder types

Other

Identifiers

NCT01531348

RP-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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