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

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ClinicalTrials.gov Identifier: NCT02709876
Recruitment Status : Active, not recruiting
First Posted : March 16, 2016
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Stem Cells Arabia

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Biological: Stem Cell Transplantation Phase 1 Phase 2

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. 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2014
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Stem Cells
Intravitreal Injection of bone marrow derived CD34+, CD133+, CD271+ stem cells.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. ETDRS Visual acuity change [ Time Frame: 12 months from baseline ]

Secondary Outcome Measures :
  1. Quality of Life: Questionnaire VFQ-25 (Visual Function Questionnaire-25) [ Time Frame: 12 months from baseline ]
  2. Color Vision: Ishihara Color Test [ Time Frame: 12 months from baseline ]
  3. Contrast sensitivity: CSV-1000E [ Time Frame: 12 months from baseline ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709876


Locations
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Jordan
Stem Cells Arabia
Amman, Jordan, 11953
Sponsors and Collaborators
Stem Cells Arabia
More Information
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Responsible Party: Stem Cells Arabia
ClinicalTrials.gov Identifier: NCT02709876    
Other Study ID Numbers: SCA-RP1
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
 Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn