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Critical Limb IschemiaPhase 1/2CLI-001NCT00392509

ALD-301 for Critical Limb Ischemia, Randomized Trial

A Phase 1/2 study testing ALDH-br bone marrow cells vs. mononuclear bone marrow cells in people with Critical Limb Ischemia and Peripheral Arterial Disease, run by Aldagen at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will treat patients with such severe lower leg ischemia or vascular compromise that they have pain at rest. The goal is to compare treatment of the patient's painful disorder by injecting cells into the calf of the leg and testing for circulatory improvement. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ALDH-br bone marrow cells vs. mononuclear bone marrow cells
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
5 sitesUnited States
Study dates
Oct 2006to Dec 2008
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
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  • 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
  • Cardiovascular conditions:
  • 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;

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Saint Joseph's Research Institute

    Atlanta, Georgia, 30342

  • Cardiology PC

    Birmingham, Alabama, 35211

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Texas Heart Institute, Stem Cell Center, 6770 Bertner, St Luke's Episcopal Hospital

    Houston, Texas, 77030

  • University of Indiana at Indianapolis

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

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

This study will treat patients with such severe lower leg ischemia or vascular compromise that they have pain at rest. The goal is to compare treatment of the patient's painful disorder by injecting cells into the calf of the leg and testing for circulatory improvement. A treatment will given at random to two groups and will be injection into the calf muscle with ALD-301 (specially processed stem and progenitor cells) from the patient's own bone marrow, or with cells processed by more routine that minimally purifies the cells. The study goal is to see if the ALD-301 cells are more effective in generating new small blood vessels to improve the circulation to the affected leg.

Read the detailed description

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:

  1. ankle-brachial index of systolic blood pressure
  2. the transcutaneous oxygen measurements obtained from the skin of the treated leg
  3. the patient's perception of his/her quality of life as measured by two different, validated questionnaires
  4. Measurements of of heel/foot ulcers, if present, to monitor degree of healing if it occurs
  5. 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.

Being tested
ALDH-br bone marrow cells vs. mononuclear bone marrow cells
Keywords
critical limb ischemia, cell therapy for angiogenesis, aldehyde dehydrogenase-bright cells, peripheral artery disease, peripheral vascular disease, leg pain, PVD, PAD, CLI, amputation, limb salvage
Medical subject headings
Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALDH-br bone marrow cells vs. mononuclear bone marrow cellsProcedure or surgery

    Surgery

Study groups in NCT00392509
Study groupRoleWhat they receive
2ExperimentalUnfractionated Autologous Mononuclear Bone Marrow
Receives: Procedure: ALDH-br bone marrow cells vs. mononuclear bone marrow cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. adverse events

    Measured: 6 months

  2. ankle-brachial systolic pressure index

    Measured: 3 mo

  3. transcutaneous oxygen value (mm Torr)

    Measured: 3 mo

  4. quality of life (questionnaires)

    Measured: 3 mo

Secondary outcomes (4)

  1. size of lower extremity ulcer(s)

    Measured: 3 mo

  2. peripheral nerve conduction exam

    Measured: 3 mo

  3. level of pain at rest (questionnaire)

    Measured: 3 mo

  4. limb clinical status

    Measured: 3 mo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00392509
Sponsor's protocol ID
BB IND 12875
Acronym
CLI-001
Status last verified
May 2009
First submitted
25 Oct 2006
Last updated
14 May 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Perin EC, Silva G, Gahremanpour A, Canales J, Zheng Y, Cabreira-Hansen MG, Mendelsohn F, Chronos N, Haley R, Willerson JT, Annex BH. A randomized, controlled study of autologous therapy with bone marrow-derived aldehyde dehydrogenase bright cells in patients with critical limb ischemia. Catheter Cardiovasc Interv. 2011 Dec 1;78(7):1060-7. doi: 10.1002/ccd.23066. Epub 2011 May 18.

    PubMed 21594960

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ALDH-br bone marrow cells vs. mononuclear bone marrow cells in people with Critical Limb Ischemia and Peripheral Arterial Disease, run by Aldagen at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adverse events (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00392509, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2009.

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