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Stem Cell Mobilization in Diabetic Neuropathy Subjects Receiving SB-509

Primary Purpose

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Polyneuropathy

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

SB-509

Placebo

SB-509

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Polyneuropathy, Stem Cells

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Key Inclusion Criteria:

Have a clinical diagnosis of diabetes mellitus type I or II for at least 12 months prior to the study.
Have received a diagnosis of sensorimotor diabetic neuropathy from a neurologist (a doctor who specializes in disorders of the nervous system) or endocrinologist (a doctor who specializes in diabetes).
Have reduced nerve conduction velocity in any lower extremity nerve: peroneal, tibial or sural due to diabetic polyneuropathy
If female and of childbearing potential, agree to use a medically acceptable physical barrier method during the study.
Have blood pressure < 140/90 mm Hg
Body mass index (BMI) < 38 kg/m2

Key Exclusion Criteria:

Subjects with the following are NOT eligible to participate in this study:

Have moderate to severe ischemic heart disease, any history of congestive heart failure, or have had a myocardial infarction (heart attack) within the previous 6 months.
Have chronic foot or leg ulcers for >1 month, gangrene in the legs, or any previous amputation of the lower extremity.
Have a history of cancer within the past 5 years (except for curable non-melanoma cancer of the skin, superficial bladder cancer in complete remission, or any other cancer that has been in complete remission for at least 5 years).
Have colon polyps. If patients have a history of benign colonic polyps that have been removed, they must have evidence of a normal colonoscopy within the last 12 months.
Require any drug that depresses patients' immune systems (such as methotrexate, cyclophosphamide, or cyclosporine) when they receive the study drug and for 30 days afterwards.
Have a known disorder that affects patients' immune systems (such as HIV/AIDS, hepatitis B virus [HBV], hepatitis C virus [HCV], sarcoidosis, tuberculosis, rheumatoid arthritis, or autoimmune disorders).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Arm Description

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Outcomes

Primary Outcome Measures

Stem cells circulating in peripheral blood

Secondary Outcome Measures

Safety and Efficacy of SB-509

Full Information

NCT ID

NCT00665145

First Posted

April 21, 2008

Last Updated

October 30, 2012

Sponsor

Sangamo Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT00665145

Brief Title

Stem Cell Mobilization in Diabetic Neuropathy Subjects Receiving SB-509

Official Title

A Phase 2 Study of Stem-Cell-Mobilization in Subjects With Diabetic Neuropathy Receiving SB-509

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sangamo Therapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary and secondary objectives of this study are: Primary: To evaluate stem-cell-mobilization in subjects with diabetic neuropathy receiving SB-509. Stem cell mobilization will be assessed by evaluating the presence of stem cells circulating in peripheral blood. Secondary: To evaluate the safety of SB-509 in subjects treated with SB-509 with diabetic neuropathy; and to compare the effect of SB-509 versus placebo on a pre-defined multi-endpoint analysis that includes visual analog scale for pain intensity (VASPI), total neuropathy score (TNS), evoked nerve conduction velocity (NCV) and quantitative sensory testing (QST)

Detailed Description

SB-509 contains the gene (DNA-a kind of biological "blueprint") for a protein. When a researcher injects SB-509 into your legs, the drug enters the muscle and nerve cells around the injection site and causes these cells to make a protein. This protein causes your cells to increase production of another protein called vascular endothelial growth factor (VEGF), which may improve the structure and function of nerves. In addition, there are changes in the levels of 28 additional proteins in your cells. These proteins function to promote the growth of cells, are structures in cells, help synthesize products, and affect immune cells, and some have unknown functions. This increase in your own VEGF proteins may protect and repair the damaged nerves caused by diabetic neuropathy. This study is intended to further evaluate the mechanism of SB-509 action.

6. Conditions and Keywords

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

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Polyneuropathy

Keywords

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Polyneuropathy, Stem Cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Cohort 1

Arm Title

Arm Type

Experimental

Arm Description

Cohort 2

Arm Title

Arm Type

Placebo Comparator

Arm Description

Cohort 3

Arm Title

Arm Type

Experimental

Arm Description

Cohort 4

Intervention Type

Drug

Intervention Name(s)

SB-509

Intervention Description

Active drug

Intervention Type

Drug

Intervention Name(s)

SB-509

Intervention Description

Active drug

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Intervention Type

Drug

Intervention Name(s)

SB-509

Intervention Description

Active drug

Primary Outcome Measure Information:

Title

Stem cells circulating in peripheral blood

Time Frame

One year

Secondary Outcome Measure Information:

Title

Safety and Efficacy of SB-509

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Key Inclusion Criteria: Have a clinical diagnosis of diabetes mellitus type I or II for at least 12 months prior to the study. Have received a diagnosis of sensorimotor diabetic neuropathy from a neurologist (a doctor who specializes in disorders of the nervous system) or endocrinologist (a doctor who specializes in diabetes). Have reduced nerve conduction velocity in any lower extremity nerve: peroneal, tibial or sural due to diabetic polyneuropathy If female and of childbearing potential, agree to use a medically acceptable physical barrier method during the study. Have blood pressure < 140/90 mm Hg Body mass index (BMI) < 38 kg/m2 Key Exclusion Criteria: Subjects with the following are NOT eligible to participate in this study: Have moderate to severe ischemic heart disease, any history of congestive heart failure, or have had a myocardial infarction (heart attack) within the previous 6 months. Have chronic foot or leg ulcers for >1 month, gangrene in the legs, or any previous amputation of the lower extremity. Have a history of cancer within the past 5 years (except for curable non-melanoma cancer of the skin, superficial bladder cancer in complete remission, or any other cancer that has been in complete remission for at least 5 years). Have colon polyps. If patients have a history of benign colonic polyps that have been removed, they must have evidence of a normal colonoscopy within the last 12 months. Require any drug that depresses patients' immune systems (such as methotrexate, cyclophosphamide, or cyclosporine) when they receive the study drug and for 30 days afterwards. Have a known disorder that affects patients' immune systems (such as HIV/AIDS, hepatitis B virus [HBV], hepatitis C virus [HCV], sarcoidosis, tuberculosis, rheumatoid arthritis, or autoimmune disorders).

Facility Information:

City

La Jolla,

State/Province

California

ZIP/Postal Code

92037

Country

United States

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.sangamo.com

Description

Company website

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Stem Cell Mobilization in Diabetic Neuropathy Subjects Receiving SB-509

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