ALD-301 for Critical Limb Ischemia, Randomized Trial (CLI-001)
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|ClinicalTrials.gov Identifier: NCT00392509|
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : May 14, 2009
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|Condition or disease||Intervention/treatment||Phase|
|Critical Limb Ischemia Peripheral Arterial Disease Peripheral Vascular Disease||Procedure: ALDH-br bone marrow cells vs. mononuclear bone marrow cells||Phase 1 Phase 2|
Patients will be recruited who have critical limb ischemia with pain at rest. The study will select patients for treatment and follow them for three months after intervention. The treatment will consist of drawing about 2/3 of a cup of bone marrow from the patient's hip bone, then processing the collected bone marrow will be as follows:
- The test group's bone marrow will be processed and sorted to identify the aldehyde dehydrogenase bright ALDH-br stem and progenitor cells (ALD-301). These cells will be injected into the calf muscle of the patient in clinic.
- The control group will have the same amount of bone marrow collected but it will undergo a simpler process to isolate the mononuclear cells from the whole bone marrow, removing most of the red cells and granulocytes from cell preparation for injection.
The patients will be monitored for adverse events related to this process to determine the safety of the approach. They will also be tested at intervals during the study to compare baseline values of each patient with the post-treatment values of:
- ankle-brachial index of systolic blood pressure
- the transcutaneous oxygen measurements obtained from the skin of the treated leg
- the patient's perception of his/her quality of life as measured by two different, validated questionnaires
- Measurements of of heel/foot ulcers, if present, to monitor degree of healing if it occurs
- the patient's perception of his/her level of pain in the leg
The patients will receive a call at 6 months to report on additional life events following the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase I-II Randomized Autologous Bone Marrow Derived Aldehyde Dehydrogenase-Bright (ALDHbr) Cells Against Unfractionated Autologous Mononuclear Bone Marrow in Patients With Rutherford 4 or 5 Peripheral Arterial Occlusive Disease|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Unfractionated Autologous Mononuclear Bone Marrow
Procedure: ALDH-br bone marrow cells vs. mononuclear bone marrow cells
- adverse events [ Time Frame: 6 months ]
- ankle-brachial systolic pressure index [ Time Frame: 3 mo ]
- transcutaneous oxygen value (mm Torr) [ Time Frame: 3 mo ]
- quality of life (questionnaires) [ Time Frame: 3 mo ]
- size of lower extremity ulcer(s) [ Time Frame: 3 mo ]
- peripheral nerve conduction exam [ Time Frame: 3 mo ]
- level of pain at rest (questionnaire) [ Time Frame: 3 mo ]
- limb clinical status [ Time Frame: 3 mo ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients 18 years of age or greater with atherosclerotic vascular disease that is viewed as not readily amenable to reconstructive surgery and Rutherford Category 4 ischemia (ischemic rest pain) and Rutherford Category 5 ischemia (ulceration or tissue necrosis) and by the judgment of their referring physician are not reasonable candidates for revascularization options of either percutaneous balloon angioplasty or a surgical revascularization.
- Objective evidence of severe peripheral arterial disease will include an ankle brachial index (ABI) of less than 0.5, or, in the case of patients who have vessels calcified and thereby "non-compressible" vessels metatarsal pulse volume recording (PVR) that is flat or barely pulsatile in the diseased limb on two consecutive examinations performed at least one week apart.
- Patients competent to give informed consent.
- No active malignant disease that could involve the bone marrow, or history of treatment of malignant disease that could have damaged the bone marrow.
- Before being accepted for the study the patient must be screened for human immunodeficiency virus, hepatitis B virus, hepatitis C virus, human transmissible spongiform encephalopathy, including Creutzfeldt-Jacob Disease, Treponema pallidum, and have a negative standard infectious disease panel including a CMV PCR test.
- Patients who are hemodynamically stable.
- Patients with poorly controlled diabetes mellitus (HbA1C > 8%)
- Patients with renal insufficiency (creatinine > 2.5).
- Patients with evidence of infectious disease as determined by e. above or other medical findings.
- Pregnant women (women capable of childbearing must have a negative pregnancy test).
- Patients with cognitive impairments.
- Other comorbid disease that would be expected to result in less than one year life expectancy
- Past malignancy or history of chemotherapy or radiation affecting the bone marrow.
- History of inflammatory or progressively fibrotic conditions: .e.g., rheumatoid arthritis, systemic lupus erythematosis, vasculitic disorders, idiopathic pulmonary fibrosis, retroperitoneal fibrosis
- Infection as evidenced by WBC count of >15,000 and/or temperature >38 degrees C. Large area of cellulitis in the afflicted limb that in the opinion of the investigators would require the institution of antibiotics OR evidence of osteomyelitis corroborated by radiographic or scintigraphic examination
- Exercise limiting angina ( Canadian Cardiovascular Society Class 3 (Appendix 7);
- Congestive heart failure (New York Heart Association class 3 (Appendix 5);
- Unstable angina;
- Acute ST elevation myocardial infarction (MI) within 1month;
- Transient ischemic attack or stroke within 1 month;
- Severe valvular disease
- Patients with any history of organ transplants;
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392509
|United States, Alabama|
|Birmingham, Alabama, United States, 35211|
|United States, Georgia|
|Saint Joseph's Research Institute|
|Atlanta, Georgia, United States, 30342|
|United States, Indiana|
|University of Indiana at Indianapolis|
|Indianapolis, Indiana, United States, 46202|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Texas|
|Texas Heart Institute, Stem Cell Center, 6770 Bertner, St Luke's Episcopal Hospital|
|Houston,, Texas, United States, 77030|
|Principal Investigator:||Emerson C Perin, M.D., Ph.D.||Stem Cell Center, Texas Heart Institute, St Luke's Episcopal Hospital, 6770 Bertner , Suite 1020 Texas Medical Center,Houston, Texas 77030|
|Principal Investigator:||Robert Mitchell, MD||Duke University|
|Principal Investigator:||Michael Murphy, MD||University of Indiana at Indianapolis|
|Principal Investigator:||Nicolas Chronos, MD||Saint Joseph's Research Institute|
|Principal Investigator:||Farrell Mendelsohn, MD||Cardiology PC|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Laurence Keller, MD, Aldagen, Inc.|
|Other Study ID Numbers:||
BB IND 12875
|First Posted:||October 26, 2006 Key Record Dates|
|Last Update Posted:||May 14, 2009|
|Last Verified:||May 2009|
critical limb ischemia
cell therapy for angiogenesis
aldehyde dehydrogenase-bright cells
peripheral artery disease
peripheral vascular disease
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases