Treatment of Optic Neuropathies Using Autologous Bone Marrow-Derived Stem Cells

Optic Neuropathy Clinical Trial

Official title:

Treatment of Optic Neuropathies Using Autologous Bone-Marrow Derived Clusters of Differentiation (CD) 34+, 133+, and 271+ Stem Cells: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02638714
• Other study ID #: SCA-ON1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 2013
• Est. completion date: October 1, 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 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.

Description:

Optic nerve atrophy (ONA) is a condition defined as a damage to the optic nerve that harmfully affects central and peripheral vision. ONA may occur as a result of optic neuritis, compression by tumors or aneurysms, toxic and nutritional neuropathies, trauma, or as a secondary complication to other systemic diseases such as diabetes. Symptoms of ONA vary diversely, but mainly include blurred vision and a reduction in optic sharpness and color visualization. ONA is irreversible process, and current medical strategies focus on finding the underlying cause, and trying to prevent further vision loss and protect the other healthy eye. 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 24 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 optic nerves and supporting issues and vasculature, and the availability of clinical-grade purification system (CliniMACS) and Microbeads to purify the target cell populations in clinically-approved methods. Anticipated outcomes of this study are defined in an overall improvement of vision, restoration of functions to damaged optic nerves, and improvement in quality of life of patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Optic Nerve Diseases
• Optic Neuropathy
• Peripheral Nervous System Diseases

Intervention

Biological:
• Stem Cells
Intervention: Transplantation of autologous purified stem cells

Locations

Country	Name	City	State
Jordan	Stem Cells of 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	Reduction in degeneration of the optic nerve using the visual field assessment with the Humphrey automated and Goldmann manual perimeters		24 months
Secondary	improvement in visual function using the documentation of visual acuity using the Snellen chart		24 months