Recruiting
Phase 1

Stem Cells

Sponsor:

Murphy, Michael P., MD

Code:

NCT00113243

Conditions

Peripheral Vascular Diseases

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

adult stem cells

Study Details

Brief summary:

The purpose of this study is to determine if bone marrow derived adult stem cells are safe and effective in inducing development of new blood vessels (angiogenesis) in the legs of patients with severe peripheral vascular disease.

Conditions

Peripheral Vascular Diseases

Study ID

NCT00113243

Start date

Dec, 2004

Status verified date

Jun, 2005

Completion date

Dec, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Severe peripheral vascular disease not amenable to bypass or angioplasty
  • Age >21 years old
  • Normal renal function (creatinine < 1.6)

Exclusion Criteria:

  • Congestive heart failure (ejection fraction \[EF\]<30%)
  • History of cancer or myeloproliferative disorders
  • Proliferative retinopathy
  • Pregnancy
  • Cognitively disabled

Study Design

Enrollment

20 participants

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

adult stem cells

Primary outcome measure

  • Adverse events recorded in the 12 week study period [ Time Frame: undefined ]
  • Serious Adverse events recorded for one year [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Michael P Murphy, MD

(317) 630-8288mipmurph@iupui.edu

Julie Lacy, RN

(317)962-0138julacy@iupui.edu

Locations

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Michael P Murphy, MD

317-630-8288mipmurph@iupui.edu

Janet Klein, RN

(317) 962-0287jswklein@iupui.edu

More Information

Sponsor

Murphy, Michael P., MD

Last update posted

Jun 24, 2005

Last verified

Jun, 2005

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Murphy, Michael P., MD on 2005-06-24.