NCT01480414

Brief Summary

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 the investigators 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. Indeed, recent studies have shown that bone-marrow mononuclear cell (BM-MNC) implantation increases collateral vessel formation in patients with limb ischemia. So the investigators determine to evaluate the efficacy of repeated MNC transplantation in patients with ischemic lower limb.

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 Sep 2010

Geographic Reach
1 country

1 active site

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

September 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

December 27, 2012

Status Verified

July 1, 2010

Enrollment Period

1.6 years

First QC Date

November 23, 2011

Last Update Submit

December 25, 2012

Conditions

Ischemic Ulcer

Keywords

bone marrow mono nuclear stem cell ischemic ulcer

Outcome Measures

Primary Outcomes (1)

  • side effects

    evaluation the side effect of cell injection like:allergic reaction,fever,skin eruption,pain increasing,decrease in walking distance,ulcer severity

    3months

Secondary Outcomes (4)

  • PFWD

    3months

  • ABI

    3months

  • size and depth of ulcer

    3months

  • Amputation

    6months

Study Arms (2)

4times injection

EXPERIMENTAL

the patients with ischemic lower limb ulcer who underwent 4times stem cell injection.

Biological: 4times injection

one injection

EXPERIMENTAL

Patients with peripheral artery disease underwent cell transplantation just one time.

Biological: stem cell transplantation

Interventions

4times injectionBIOLOGICAL

bone marrow derived mono nuclear stem cell

4times injection
stem cell transplantationBIOLOGICAL

Mono nuclear stem cell transplantation by intra muscular injection to the ischemic lower limb

one injection

Eligibility Criteria

Age20 Years - 62 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ischemic lower limb based on TASK guide line
  • Rutherford score:2,3
  • ABI\<0.6
  • Absolute ankle pressure \< 60 mmHg
  • Both gender
  • Age:20-62years

You may not qualify if:

  • EF\<30%
  • Cr\>2
  • HbA1c\>8%
  • Bone marrow disorders:leukemia
  • Cognitive disorders
  • Infections
  • MI with ST elevation during last month
  • Malignancy
  • Immunologic or rheumatologic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (1)

  • Molavi B, Zafarghandi MR, Aminizadeh E, Hosseini SE, Mirzayi H, Arab L, Baharvand H, Aghdami N. Safety and Efficacy of Repeated Bone Marrow Mononuclear Cell Therapy in Patients with Critical Limb Ischemia in a Pilot Randomized Controlled Trial. Arch Iran Med. 2016 Jun;19(6):388-96.

    PMID: 27293053DERIVED

MeSH Terms

Interventions

Stem Cell Transplantation

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Hamid Gourabi, PhD

    Head of Royan Institute

    STUDY CHAIR

  • mohammad zafarghandi, MD

    surgery scientist

    STUDY DIRECTOR

  • Nasser Aghdami, MD,PhD

    head of Royan cell therapy center

    STUDY DIRECTOR

  • Behnam Molavi, MD

    Surgery scientist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2011

First Posted

November 28, 2011

Study Start

September 1, 2010

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

December 27, 2012

Record last verified: 2010-07

Locations

IR(1)