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Peripheral Vascular DiseasesPhase 1/2NCT00677404

Autologous Transplantation of Bone Marrow Mononuclear Cell (BM-MNC) With and Without Granulocyte-Colony Stimulation Factor (G-CSF) for Treatment of Chronic Lower Limb Ischemic Patients

A Phase 1/2 study testing BM-MNC injection in people with Peripheral Vascular Diseases and Ischemia, run by Royan Institute at 2 sites in Iran.

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

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of mononuclear cells with and without G-CSF in patients with chronic lower limb ischemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Vascular Diseases, Ischemia
What is being tested?
BM-MNC injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesIran
Study dates
Jan 2008to Jan 2010
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

  • Presence of Critical Limb ischemia according to the guidelines of the Transatlantic Consensus Group (TASC) Rutherford grade II or III. Perfusion is measured with absolute perfusion pressure and ankle-brachial index (ABI) and transcutaneous oxygen tension (TcpO2); for inclusion, ABI has to be less than or equal to 0.6 or absolute ankle pressure must be less than 60 mmHg. If ABI is technically not feasible, e.g. in patients with media calcification, inclusion criteria are a tcpO2 value (supine, forefoot, 44°C) of less than 20 mmHg if there is no tissue loss, or a tcpO2 of less than 40 mmHg if there is tissue loss.
  • No sufficient response to best standard care delivered for six weeks.
  • No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist
  • Signed informed consent
  • Absence of life-threatening complications from the ischemic limb

Who cannot join

  • Expected life span less than six months
  • Bone marrow diseases which preclude transplantation (eg lymphoma, leukaemia, myelodysplastic syndrome and others)
  • 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).
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  • 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 more than 38C. Large area of cellulitis in the afflicted limb that in the opinion ofthe investigators would require the institution of antibiotics OR evidence of osteomyelitis corroborated by radiographic or scintigraphic examination
  • Cardiovascular conditions:
  • EF<30%
  • Acute ST elevation myocardial infarction (MI) within 1month;
  • Transient ischemic attack or stroke within 1 month;
  • Severe valvular disease
  • CVA
  • Patients with any history of organ transplants

Trial locations and contacts

2 sites in 1 country.

Iran2 sites

  • Royan Institute

    Tehran, Tehran Province, 1665659911

  • Tehran University of medical sciences, Vascular Surgery department, Sina Hospital

    Tehran, Tehran Province

Other trials in Iran

About this study

Official title: Evaluation of Clinical Outcome in Advanced Chronic Lower Limb Ischemia by Stem Cell Transplantation With or Without (Granulocyte-colony Stimulation Factor) G-CSF Injection

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of mononuclear cells with and without G-CSF in patients with chronic lower limb ischemia.

Read the detailed description

Critical limb ischemia (CLI) results from severe occlusive disease that impairs distal limb perfusion to the point where oxygen delivery is no longer adequate to meet the metabolic needs of the tissue, even under resting conditions. The limits of peripheral artery disease (PAD) compensatory mechanisms, such as distal vasodilatation and collateral formation, have been exceeded at this point. PAD is a widespread disease, affecting up to 15% of all adults older than 55 years. Formation of true new blood vessels, or angiogenesis, and development of collateral vessels from preexisting blood vessels, or arteriogenesis, is important in the pathophysiology of vascular disease. By stimulating these processes we might be able to provide an alternative treatment strategy for patients with lower limb ischemia. In response to tissue injury and remodeling, neovascularization usually occurs via the proliferation and migration of progenitor endothelial cells (EPC) from preexisting vasculature. The EPCs resident within bone marrow and peripheral blood, so it seems implantation of BM cells can contribute to injury-induced and pathology induced neovascularization. Indeed, recent studies have shown that bone-marrow mononuclear cell (BM-MNC) implantation increases collateral vessel formation in both ischemic limb models and patients with limb ischemia. In addition, granulocyte-colony stimulation factor could mobilize the EPCs to peripheral blood. After BM-MNC implantation, G-CSF can contribute more EPC in PB for effective angiogenesis in PAD patients.

In this study, Bone marrow puncture will be performed in a common manner. The iliac crest is punctured under epidural anesthesia and 400 mL of bone marrow will be aspirated. The MNCs are isolated under good manufacturing practice conditions by Ficoll density separation and is intramuscularly injected (40 sites, in 3 × 3 cm distance, 1-1.5 cm deep, into ischemic leg. In some patients G-CSF (10 microgr/day) is administration by subcutaneous injection from day of cell injection for 5 days.

Being tested
BM-MNC injection
Keywords
Peripheral vascular diseases, chronic lower limb ischemia
Medical subject headings
Peripheral Vascular Diseases, Ischemia

What participants receive

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

  • BM-MNC injectionBiological

    Bone marrow aspiration A total volume of 400 ml bone marrow will be aspirated from the iliac crest under epidural anaesthesia

Study groups in NCT00677404
Study groupRoleWhat they receive
stem cell recipientExperimentalthe patients with peripheral vascular disease who receive bone marrow derived mono nuclear cells
Receives: Biological: BM-MNC injection

What is being measured

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

  1. Major amputation

    Measured: six months

Secondary outcomes (5)

  1. Minor amputation

    Measured: six months

  2. Number and extent of leg ulcers

    Measured: six months

  3. Resolvement of rest pain

    Measured: six months

  4. Improvement of ankle-brachial index (ABI)

    Measured: six months

  5. Improvement of pain free walking distances ( PFWD)

    Measured: six months

Timeline

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

  1. First posted14 May 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionOct 2009
  4. Study completionJan 2010

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00677404
Sponsor's protocol ID
Royan-PVD-001
Status last verified
Apr 2010
First submitted
12 May 2008
Last updated
29 Jul 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Zafarghandi MR, Ravari H, Aghdami N, Namiri M, Moazzami K, Taghiabadi E, Fazel A, Pournasr B, Farrokhi A, Sharifian RA, Salimi J, Moini M, Baharvand H. Safety and efficacy of granulocyte-colony-stimulating factor administration following autologous intramuscular implantation of bone marrow mononuclear cells: a randomized controlled trial in patients with advanced lower limb ischemia. Cytotherapy. 2010 Oct;12(6):783-91. doi: 10.3109/14653240903518163.

    PubMed 20078390

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BM-MNC injection in people with Peripheral Vascular Diseases and Ischemia, run by Royan Institute at 2 sites in Iran.

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 5 inclusion and 18 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 29 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Iran. 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?

Major amputation (time frame: six months). 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 NCT00677404, 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 29 Jul 2011.

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