NCT02638714

Brief Summary

A single arm, single center trial to assess the safety and efficacy of restoring function in damaged optic nerves using autologous purified populations of bone-marrow derived stem cells (BM-SCs) through a 24 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
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2013

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, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

8.4 years

First QC Date

December 7, 2015

Last Update Submit

March 15, 2020

Conditions

Optic Neuropathy

Keywords

Optic NeuropathiesStem Cell Therapy

Outcome Measures

Primary Outcomes (1)

  • Reduction in degeneration of the optic nerve using the visual field assessment with the Humphrey automated and Goldmann manual perimeters

    24 months

Secondary Outcomes (1)

  • improvement in visual function using the documentation of visual acuity using the Snellen chart

    24 months

Study Arms (1)

Stem Cells

EXPERIMENTAL

Intervention: Transplantation of autologous purified stem cells

Biological: Stem Cells

Interventions

Stem CellsBIOLOGICAL

Intervention: Transplantation of autologous purified stem cells

Stem Cells

Eligibility Criteria

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

You may qualify if:

  • Patient should suffer from Optic Nerve Atrophy diseases like diabetic retinopathy and retinal pigmentation.
  • Age in between 18-55 years old
  • Willingness to undergo bone marrow derived autologous cell therapy.
  • Ability to comprehend the explained protocol
  • Ability and willingness to regularly visit to hospital for protocol and follow up

You may not qualify if:

  • Patients with preexisting or current systemic disease such as lung, liver, gastrointestinal, cardiac, immunodeficiency, syphilis, or clinically relevant polyneuropathies.
  • History of life threatening allergic or immune- mediated reaction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stem Cells of Arabia

Amman, 11953, Jordan

RECRUITING

MeSH Terms

Conditions

Optic Nerve Diseases

Condition Hierarchy (Ancestors)

Cranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Adeeb AlZoubi, PhD

    PRINCIPAL INVESTIGATOR

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

December 7, 2015

First Posted

December 23, 2015

Study Start

April 1, 2013

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

March 17, 2020

Record last verified: 2020-03

Locations

JO(1)