NCT00665145

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

4 active sites

Status
completed

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

January 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 1, 2012

Status Verified

October 1, 2012

Enrollment Period

1.8 years

First QC Date

April 21, 2008

Last Update Submit

October 30, 2012

Conditions

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

Keywords

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic PolyneuropathyStem Cells

Outcome Measures

Primary Outcomes (1)

  • Stem cells circulating in peripheral blood

    One year

Secondary Outcomes (1)

  • Safety and Efficacy of SB-509

    One year

Study Arms (4)

1

EXPERIMENTAL

Cohort 1

Drug: SB-509

2

EXPERIMENTAL

Cohort 2

Drug: SB-509

3

PLACEBO COMPARATOR

Cohort 3

Drug: Placebo

4

EXPERIMENTAL

Cohort 4

Drug: SB-509

Interventions

SB-509DRUG

Active drug

1
PlaceboDRUG

Placebo

3

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

La Jolla, California, 92037, United States

Location

Unknown Facility

Walnut Creek, California, 94598, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes Complications

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 21, 2008

First Posted

April 23, 2008

Study Start

January 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 1, 2012

Record last verified: 2012-10

Locations

US(4)