Autologous CD34+ Stem Cell Injection for Severe Intermittent Claudication (Leg Pain)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Losordo, Douglas, M.D..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Losordo, Douglas, M.D.
ClinicalTrials.gov Identifier:
NCT00311805
First received: April 4, 2006
Last updated: November 7, 2011
Last verified: November 2011

April 4, 2006
November 7, 2011
April 2006
December 2012   (final data collection date for primary outcome measure)
Safety of Intramuscular administration of CD34-positive cells [ Time Frame: All ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00311805 on ClinicalTrials.gov Archive Site
Functional improvement [ Time Frame: Week 12, Month 6, Month 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Autologous CD34+ Stem Cell Injection for Severe Intermittent Claudication (Leg Pain)
Injection of Autologous CD34-Positive Stem Cells for Neovascularization and Symptom Relief in Patients With Severe Intermittent Claudication

The goal of the study is to determine the safety and possible effectiveness of various doses of autologous (one's own) stem cells, delivered with a needle into the regions of the leg with poor blood flow in patients with blocked leg arteries that results in claudication (pain when walking). Stem cells are primitive cells produced by the bone marrow that can develop into blood cells or other types of cells. In addition to determining whether this new approach is safe, the diagnostic tests may offer preliminary insights into the usefulness of this approach for treating intermittent claudication - the condition where areas in the leg are lacking enough oxygen and blood flow to keep the leg muscle working well, causing pain and cramping upon walking.

This study is a double-blind, randomized study to compare CD34-positive stem cells versus a placebo agent (salt water solution known as normal saline). The patient will have a 3:1 chance of their stem cells versus the placebo. Regardless of a patient receiving placebo or treatment, all patients will undergo all of the pre-treatment phases of this study, which includes the stem cell mobilization and apheresis procedure.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Peripheral Artery Disease
  • Severe Intermittent Claudication
Biological: Autologous Stem Cells (CD34+)
Intramuscular Injections
  • Active Comparator: 1
    Intervention: Biological: Autologous Stem Cells (CD34+)
  • Active Comparator: 2
    Intervention: Biological: Autologous Stem Cells (CD34+)
  • Placebo Comparator: 3
    Intervention: Biological: Autologous Stem Cells (CD34+)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
Not Provided
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males or females equal to or greater than 21 years old
  • Patients with infra-inguinal atherosclerosis with a stenosis or occlusion of a major vessel in the affected limb(s) of one or more of the following arteries: superficial femoral, popliteal, or one or more infrapopliteal arteries, which is/are non-reconstructable.
  • Patients with symptoms of Severe Intermittent Claudication in at least 1 lower limb persisting for at least 6 months (Rutherford Class 3).
  • Patients who have a diagnosis of Peripheral Arterial Disease (PAD) in at least 1 lower limb secondary to atherosclerosis, for at least 6 months.

Exclusion Criteria:

  • Patients who have had successful aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 3 month preceding screening.
  • Patients with iliac disease amenable to revascularization.
  • Patients judged to be a suitable candidate for surgical or percutaneous revascularization in the limb in which treatment is proposed.
  • Patients with Critical Limb Ischemia (CLI), Rutherford Symptom Score of 4,5, or 6.
  • Patients in who arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00311805
STU00023438/STU00000487, 11931-01
Yes
Losordo, Douglas, M.D.
Losordo, Douglas, M.D.
Not Provided
Principal Investigator: Douglas W. Losordo, M.D. Northwestern University
Losordo, Douglas, M.D.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP