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Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy

Primary Purpose

Non-exudative Age-related Macular Degeneration, Diabetic Retinopathy, Retina Vein Occlusion

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CD34+ bone marrow stem cells intravitreal

About this trial

This is an interventional treatment trial for Non-exudative Age-related Macular Degeneration focused on measuring Stem cells, intravitreal, bone marrow CD34+ cells, retinal disease, clinical trial, autologous

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age >18 years of age
visual acuity 20/100 to CF
duration of vision loss > 3 months
vision loss from macular degeneration, retinitis pigmentosa, retinal vein occlusion or diabetic retinopathy
the study eye has the worse visual acuity
no active eye or systemic disease
no history of macular edema or retinal/choroidal neovascularization requiring treatment within 6 months
no significant media opacity
no coagulopathy or other hematologic abnormality
no concurrent immunosuppressive therapy
able to keep follow-up for 6 months

Exclusion Criteria:

allergy to fluorescein dye
other concurrent retinal or optic nerve disease affecting vision

Sites / Locations

University of California Davis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem cell treated

Arm Description

Outcomes

Primary Outcome Measures

Incidence and severity of ocular adverse events

As evident on eye examination by severe decrease in vision and/or adverse effect requiring major treatment intervention directly attributable to study treatment.

Secondary Outcome Measures

The number of stem cells isolated and injected into the study eye

Will determine the yield of the bone marrow aspiration and stem cell isolation procedures.

Full Information

NCT ID

NCT01736059

First Posted

July 25, 2012

Last Updated

August 15, 2023

Sponsor

University of California, Davis

1. Study Identification

Unique Protocol Identification Number

NCT01736059

Brief Title

Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy

Official Title

A Pilot Clinical Trial of the Feasibility and Safety of Intravitreal Autologous Adult Bone Marrow Stem Cells in Treating Eyes With Vision Loss From Retinopathy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 2012 (undefined)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This pilot study is to determine whether it would be safe and feasible to inject CD34+ stem cells from bone marrow into the eye as treatment for patients who are irreversibly blind from various retinal conditions.

Detailed Description

In this pilot clinical trial, eyes with irreversible vision loss from retinal degenerative conditions (macular degeneration or retinitis pigmentosa) or retinal vascular disease (diabetic retinopathy or retinal vein occlusion) will be treated with intravitreal injection of autologous CD34+ stem cells isolated from bone marrow aspirate under Good Manufacturing Practice conditions. This study will determine whether there are any major safety and feasibility concerns using this therapy. Patients will be followed for 6 months after treatment by serial comprehensive eye examination supplemented with various retinal imaging and diagnostic tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-exudative Age-related Macular Degeneration, Diabetic Retinopathy, Retina Vein Occlusion, Retinitis Pigmentosa, Hereditary Macular Degeneration

Keywords

Stem cells, intravitreal, bone marrow CD34+ cells, retinal disease, clinical trial, autologous

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stem cell treated

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

CD34+ bone marrow stem cells intravitreal

Primary Outcome Measure Information:

Title

Incidence and severity of ocular adverse events

Description

As evident on eye examination by severe decrease in vision and/or adverse effect requiring major treatment intervention directly attributable to study treatment.

Time Frame

1 day to 6 months

Secondary Outcome Measure Information:

Title

The number of stem cells isolated and injected into the study eye

Description

Will determine the yield of the bone marrow aspiration and stem cell isolation procedures.

Time Frame

1 day

Other Pre-specified Outcome Measures:

Title

Incidence and severity of systemic adverse events

Description

Any systemic adverse event attributable to the bone marrow aspiration or intravitreal injection of the stem cells.

Time Frame

1 day to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age >18 years of age visual acuity 20/100 to CF duration of vision loss > 3 months vision loss from macular degeneration, retinitis pigmentosa, retinal vein occlusion or diabetic retinopathy the study eye has the worse visual acuity no active eye or systemic disease no history of macular edema or retinal/choroidal neovascularization requiring treatment within 6 months no significant media opacity no coagulopathy or other hematologic abnormality no concurrent immunosuppressive therapy able to keep follow-up for 6 months Exclusion Criteria: allergy to fluorescein dye other concurrent retinal or optic nerve disease affecting vision

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susanna s Park, MD PhD

Organizational Affiliation

University of California Davis Eye Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California Davis

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Once study is completed, the study findings will be published in peer reviewed publication for public access.

Citations:

PubMed Identifier

27116667

Citation

Park SS. Cell Therapy Applications for Retinal Vascular Diseases: Diabetic Retinopathy and Retinal Vein Occlusion. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(5):ORSFj1-ORSFj10. doi: 10.1167/iovs.15-17594.

Results Reference

background

PubMed Identifier

25491299

Citation

Park SS, Bauer G, Abedi M, Pontow S, Panorgias A, Jonnal R, Zawadzki RJ, Werner JS, Nolta J. Intravitreal autologous bone marrow CD34+ cell therapy for ischemic and degenerative retinal disorders: preliminary phase 1 clinical trial findings. Invest Ophthalmol Vis Sci. 2014 Dec 9;56(1):81-9. doi: 10.1167/iovs.14-15415.

Results Reference

result

Links:

URL

https://studypages.com/s/innovative-stem-cell-study-for-serious-vision-loss-at-uc-davis-eye-center-906754/

Description

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Learn more about this trial

Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy

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