Autologous Bone Marrow-Derived CD34+, CD133+, and CD271+ Stem Cell Transplantation for Retinitis Pigmentosa

Retinitis Pigmentosa Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02709876
• Other study ID #: SCA-RP1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: April 2014
• Est. completion date: March 2021

Study information

• Verified date: March 2020
• Source: Stem Cells Arabia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A single arm, single center trial to evaluate the safety and efficacy of autologous purified populations of bone-marrow derived stem cells in patients with Retinitis Pigmentosa (BM-SCs) through a 48 month follow up period.

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. This is a single arm, single center trial to assess the safety and efficacy of purified adult autologous bone marrow derived CD34+, CD133+, and CD271+ stem cells through a 48 month follow-up period. The combination of these three cell types was based on their diverse potentialities to differentiate into specific functional cell types to regenerate damaged retinal tissue, and the availability of clinical-grade purification system (CliniMACS) and microbeads to purify the target cell populations in clinically-approved methods.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: March 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Retinitis pigmentosa patients diagnosed by ophthalmologists

• Visual acuity (measured with ETDRS) less than or equal to 20/70 and visual field below 30° central in both eyes.

• Best corrected visual acuity less than 6/120 by Snellen visual acuity chart

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

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Biological:
• Stem Cell Transplantation
Bone marrow-derived CD34+, CD133+, CD271+ stem cells in 1.0 ml normal saline will be injected into the vitreous cavity.

Locations

Country	Name	City	State
Jordan	Stem Cells Arabia	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Stem Cells Arabia

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ETDRS Visual acuity change		12 months from baseline
Secondary	Quality of Life: Questionnaire VFQ-25 (Visual Function Questionnaire-25)		12 months from baseline
Secondary	Color Vision: Ishihara Color Test		12 months from baseline
Secondary	Contrast sensitivity: CSV-1000E		12 months from baseline