NCT00677404

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2008

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

July 29, 2011

Status Verified

April 1, 2010

Enrollment Period

1.8 years

First QC Date

May 12, 2008

Last Update Submit

July 27, 2011

Conditions

Peripheral Vascular DiseasesIschemia

Keywords

Peripheral vascular diseaseschronic lower limb ischemia

Outcome Measures

Primary Outcomes (1)

  • Major amputation

    six months

Secondary Outcomes (5)

  • Minor amputation

    six months

  • Number and extent of leg ulcers

    six months

  • Resolvement of rest pain

    six months

  • Improvement of ankle-brachial index (ABI)

    six months

  • Improvement of pain free walking distances ( PFWD)

    six months

Study Arms (1)

stem cell recipient

EXPERIMENTAL

the patients with peripheral vascular disease who receive bone marrow derived mono nuclear cells

Biological: BM-MNC injection

Interventions

BM-MNC injectionBIOLOGICAL

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

stem cell recipient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).
  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royan Institute

Tehran, Tehran Province, 1665659911, Iran

Location

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

Tehran, Tehran Province, Iran

Location

Related Publications (1)

  • 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.

    PMID: 20078390RESULT

Related Links

MeSH Terms

Conditions

Peripheral Vascular DiseasesIschemia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hamid Gorabi, PhD

    Royan institute, Tehran, Iran

    STUDY CHAIR

  • Mohammad reza Zafarghandi, MD

    Sina Hospital, Tehran, Iran

    STUDY CHAIR

  • Nasser Aghdami, MD., PhD

    Royan institute, Tehran, Iran

    STUDY DIRECTOR

  • Hossein Baharvand, PhD

    Royan institute, Tehran, Iran

    PRINCIPAL INVESTIGATOR

  • Hassan Ravari, MD

    Sina Hospital, Tehran, Iran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 12, 2008

First Posted

May 14, 2008

Study Start

January 1, 2008

Primary Completion

October 1, 2009

Study Completion

January 1, 2010

Last Updated

July 29, 2011

Record last verified: 2010-04

Locations

IR(2)