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Intravitreal Injection of MSCs in Retinitis Pigmentosa

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT01531348
Collaborator
Ministry of Health, Thailand (Other)
14
Enrollment
1
Location
1
Arm
99
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Actual Enrollment :
14 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
Actual Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Jul 1, 2020
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

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

Primary Outcome Measures

  1. Change from baseline in laser flare and cell measurements [up to 12 months]

Secondary Outcome Measures

  1. Change from baseline in visual function tests [up to 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Siriraj Hospital Mahidol University Bangkoknoi Bangkok Thailand 10700

Sponsors and Collaborators

  • Mahidol University
  • Ministry of Health, Thailand

Investigators

  • Principal Investigator: La-ongsri Atchaneeyasakul, MD, Siriraj Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
La-ongsri Atchaneeyasakul, Professor, Mahidol University
ClinicalTrials.gov Identifier:
NCT01531348
Other Study ID Numbers:
  • RP-001
First Posted:
Feb 10, 2012
Last Update Posted:
Sep 8, 2021
Last Verified:
Aug 1, 2021
Keywords provided by La-ongsri Atchaneeyasakul, Professor, Mahidol University
Retinitis pigmentosa
Bone marrow-derived mesenchymal stem cells
Intravitreal injection
Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa

Study Results

No Results Posted as of Sep 8, 2021