Injection of Autologous CD34 Positive Cells for Neovascularization and Symptom Relief in Patients with Severe Intermittent Claudication

What? Phase I/Pilot research study titled “Injection of Autologous CD34 Positive Cells for Neovascularization and Symptom Relief in Patients with Severe Intermittent Claudication”. The Northwestern University IRB number for this study is STU00000487.

Where? Participants receive care at Northwestern Memorial Hospital located at:  251 E. Huron St. Chicago, Illinois 60611

Why? To evaluate the safety and effectiveness of using a patient’s own CD 34+ stem cells to stimulate new blood vessel growth in their leg and therefore relieve the pain caused by poor blood supply.

How? The patient will be given a daily injection of a medication called Neupogen for 5 days in a row. This medication stimulates the patient’s bone marrow to produce the stem cells and release them into the circulation. On day 5, the patient’s stem cells will be removed by a process called apheresis which is performed by inserting a small tube into a vein in the neck.  Apheresis is a method of collecting large numbers of blood cells such as stem cells. The patient’s stem cells are collected and will be injected into the patient’s leg muscle the following day.

When? The study is currently accepting patients. Participation is for 12 months. Patients will need to travel to Northwestern Memorial Hospital for each of the 14 study visits.

Who may participate? Patients must meet the following criteria:

1. Must be 21 years of age or older
2. Must have arteries in the legs that are narrowed or blocked by atherosclerosis
3. Must have consistent  cramps or pain in legs when walking but that goes away with rest and has been persistent for at least 6 months
4. Must be able to undergo graded exercise treadmill tests
5. Must be able to provide written consent, understand the requirements of the study and return for the follow up visits

Who may not participate? Patients may not participate if they meet the following criteria:

1. Anyone diagnosed with Sickle Cell Disease or trait
2. Anyone who has tested positive for HIV, Hepatitis B or Hepatitis C
3. Anyone who has an autoimmune disease, chronic inflammatory disease or on immunosuppressive medications
4. Anyone known to have a hypersensitivity to E. Coli-derived proteins or any component of Neupogen (GCS-F)