NCT02709876

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

6.4 years

First QC Date

February 26, 2016

Last Update Submit

March 15, 2020

Conditions

Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (1)

  • ETDRS Visual acuity change

    12 months from baseline

Secondary Outcomes (3)

  • Quality of Life: Questionnaire VFQ-25 (Visual Function Questionnaire-25)

    12 months from baseline

  • Color Vision: Ishihara Color Test

    12 months from baseline

  • Contrast sensitivity: CSV-1000E

    12 months from baseline

Study Arms (1)

Stem Cells

EXPERIMENTAL

Intravitreal Injection of bone marrow derived CD34+, CD133+, CD271+ stem cells.

Biological: Stem Cell Transplantation

Interventions

Stem Cell TransplantationBIOLOGICAL

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

Stem Cells

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stem Cells Arabia

Amman, 11953, Jordan

Location

MeSH Terms

Conditions

Retinitis Pigmentosa

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 16, 2016

Study Start

April 1, 2014

Primary Completion

September 1, 2020

Study Completion

March 1, 2021

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

Locations

JO(1)