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Stem Cell Transplantation in Ocular Lesions of Behcet's Disease

Primary Purpose

Retinitis, Behcet's Syndrome

Status

Terminated

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Autologous Stem Cell Transplantation

About this trial

This is an interventional treatment trial for Retinitis focused on measuring Retinal Vasculitis, Retinal Edema, Behcet's Disease

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Behcet's Disease
Fulfilling the International Criteria for behcet's Disease (ICBD)
Ocular lesions with retinal vasculitis
Resistant to at least 3 months of combination therapy with pulse cyclophosphamide (1g/monthly), azathioprine (3 mg/kg/daily), and prednisolone 0.5 mg/kg/daily
Visual acuity not less than 4 meters finger count
Retinal edema confirmed by color photography and OCT

Exclusion Criteria:

No Vision
Active posterior uveitis
Fundus not visible

Sites / Locations

Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Behcet's Disease with ocular lesions

Outcomes

Primary Outcome Measures

1- Visual acuity by ETDRS (Early Treatment of Diabetic Retinopathy Study). 2- Retinal state and retinal edema by Color Photography, Multifocal Electroretinography, and OCT (Optic Coherent Tomography).

Secondary Outcome Measures

Full Information

NCT ID

NCT00550498

First Posted

October 27, 2007

Last Updated

November 9, 2015

Sponsor

Tehran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00550498

Brief Title

Stem Cell Transplantation in Ocular Lesions of Behcet's Disease

Official Title

Phase 1 Study of Bone Marrow - Derived Stem Cell in the Treatment of Ocular Lesions of Behcet's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Terminated

Why Stopped

No improvement obtained in 3 cases. Retinal detachment observed in 2 cases

Study Start Date

December 2007 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to find if autologous stem cell transplantation can stop the progression of intractable eye lesions of Behcet's Disease or even to improve it.

Detailed Description

To test in a pilot study the effect of autologous stem cell transplantation in stopping the progression of retinal damage of eye lesions in Behcet's Disease by repairing the vascular damage, and possibly to improve the lesions.

6. Conditions and Keywords

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

Retinitis, Behcet's Syndrome

Keywords

Retinal Vasculitis, Retinal Edema, Behcet's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Behcet's Disease with ocular lesions

Intervention Type

Biological

Intervention Name(s)

Autologous Stem Cell Transplantation

Intervention Description

Autologous bone marrow aspiration (20 ml) from iliac crest. Separation of mononuclear cells using ficoll hypaque and culture in 10% fetal bovine serum and Dulbecco modified eagles medium. After confluent stage, detachment of cells with trypsin/EDTA, and subculture. Repeated passages until obtainment of required cell number. Confluent cells of last passage are washed with tyrode solution and incubate with M199 for 60 minutes. Cells are separated using trypsin/EDTA and washed 3 times with M199 and 1% HSA. Precipitate will be diluted with heparinized M199 to make solution with 6×106 cells /ml. Sample will be tested for viability and detection of CD45, CD34, CD90, CD44, CD13, CD105, and CD166 before injection. The number of cells for injection will be between 3-5 million cells, in a maximum volume of 0.3 ml. Cells will be injected in vitreal at 3.5 millimeter of limbus with a 26 gauge insulin needle.

Primary Outcome Measure Information:

Title

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Behcet's Disease Fulfilling the International Criteria for behcet's Disease (ICBD) Ocular lesions with retinal vasculitis Resistant to at least 3 months of combination therapy with pulse cyclophosphamide (1g/monthly), azathioprine (3 mg/kg/daily), and prednisolone 0.5 mg/kg/daily Visual acuity not less than 4 meters finger count Retinal edema confirmed by color photography and OCT Exclusion Criteria: No Vision Active posterior uveitis Fundus not visible

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fereydoun Davatchi, MD

Organizational Affiliation

Rheumatology Research Center, Medical Sciences/University of Teheran

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Hormoz Shams, MD

Organizational Affiliation

Rheumatology Research Center, Medical Sciences/University of Tehran

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Behrouz Nikbin, MD

Organizational Affiliation

Department of Immunology, Medical Sciences/University of Tehran

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)

City

Tehran

ZIP/Postal Code

14114

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

15372100

Citation

Otani A, Dorrell MI, Kinder K, Moreno SK, Nusinowitz S, Banin E, Heckenlively J, Friedlander M. Rescue of retinal degeneration by intravitreally injected adult bone marrow-derived lineage-negative hematopoietic stem cells. J Clin Invest. 2004 Sep;114(6):765-74. doi: 10.1172/JCI21686.

Results Reference

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PubMed Identifier

12944502

Citation

Kicic A, Shen WY, Wilson AS, Constable IJ, Robertson T, Rakoczy PE. Differentiation of marrow stromal cells into photoreceptors in the rat eye. J Neurosci. 2003 Aug 27;23(21):7742-9. doi: 10.1523/JNEUROSCI.23-21-07742.2003.

Results Reference

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PubMed Identifier

12077603

Citation

Jiang Y, Jahagirdar BN, Reinhardt RL, Schwartz RE, Keene CD, Ortiz-Gonzalez XR, Reyes M, Lenvik T, Lund T, Blackstad M, Du J, Aldrich S, Lisberg A, Low WC, Largaespada DA, Verfaillie CM. Pluripotency of mesenchymal stem cells derived from adult marrow. Nature. 2002 Jul 4;418(6893):41-9. doi: 10.1038/nature00870. Epub 2002 Jun 20. Erratum In: Nature. 2007 Jun 14;447(7146):879-80.

Results Reference

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PubMed Identifier

23773637

Citation

Davatchi F, Nikbin B, Shams H, Sadeghi Abdollahi B, Mohyeddin M, Shahram F. Mesenchymal stem cell therapy unable to rescue the vision from advanced Behcet's disease retinal vasculitis: report of three patients. Int J Rheum Dis. 2013 Apr;16(2):139-47. doi: 10.1111/1756-185X.12068.

Results Reference

derived

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Stem Cell Transplantation in Ocular Lesions of Behcet's Disease

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