Intravitreal Injection of MSCs in Retinitis Pigmentosa

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01531348

Enrollment

Registered

2012-02-10

Start date

2012-04-30

Completion date

2020-07-31

Last updated

2021-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinitis Pigmentosa

Keywords

Retinitis pigmentosa, Bone marrow-derived mesenchymal stem cells, Intravitreal injection

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.

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.

Interventions

OTHERBM-MSC

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in laser flare and cell measurements	up to 12 months

Secondary

Measure	Time frame
Change from baseline in visual function tests	up to 12 months

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026