NCT01456819

Brief Summary

This is a randomized and single blinded study aimed to compare the efficacy between intramuscular autologous bone marrow mononuclear cells plus mesenchymal stem cell implantation and intramuscular autologous bone marrow mononuclear cells implantation only in patients with chronic critical limb ischemia. Patients will be randomized into two groups of equal number; patients in one group will be implanted with mononuclear cells and mesenchymal stem cells, and the other implanted with mononuclear cells only in the area of affected limb.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

4.8 years

First QC Date

October 4, 2011

Last Update Submit

April 9, 2015

Conditions

Critical Limb Ischemia

Keywords

autologousbone marrowcritical limb ischemiaefficacymesenchymal stem cellsmononuclear cells

Outcome Measures

Primary Outcomes (1)

  • Change in angiogenesis

    Measurement of angiogenesis by presence of peripheral pulses, capillary refill and transcutaneous oxygen saturation (TCOS).

    1 month, 3 months, 6 months, 9 months, 12 months

Secondary Outcomes (4)

  • Change in ulcer size

    1 month, 3 months, 6 months, 9 months, 12 months

  • Visual Analog Score

    1 month, 3 months, 6 months, 9 months, 12 months

  • Exercise Treadmill Test

    1 month, 3 months, 6 months, 9 months, 12 months

  • Improvement in vascularity and blood supply

    1 month, 3 months, 6 months, 9 months and 12 months

Study Arms (2)

Mononuclear and mesenchymal stem cells

EXPERIMENTAL

Autologous bone marrow-derived mononuclear cells and mesenchymal stem cells

Biological: Mononuclear and mesenchymal stem cells

Mononuclear cells only

ACTIVE COMPARATOR

Autologous bone marrow-derived mononuclear cells

Biological: Mononuclear cells

Interventions

Mononuclear and mesenchymal stem cellsBIOLOGICAL

Intramuscular administration into the ischemic limb

Also known as: BM-MNC and BM-MSC
Mononuclear and mesenchymal stem cells
Mononuclear cellsBIOLOGICAL

Intramuscular administration into the ischemic limb

Also known as: BM-MNC
Mononuclear cells only

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of critical limb ischemia leading to ischemic ulcers in which amputation is indicated
  • Not suitable for, or remain symptomatic despite angioplasty, bypass operation or collateralization

You may not qualify if:

  • Contraindication to epidural anesthesia and bone marrow aspiration
  • Contraindication to contrast angiography
  • Evidence of neoplasia and bone marrow diseases
  • Any acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
  • Patients with a limited life expectancy (\< 1 year)
  • Patients with myocardial infarction or stroke within 6 months
  • Patients with coronary intervention within 6 months
  • Renal impairment indicated by serum creatinine greater than two times upper limit of the normal range
  • Liver impairment indicated by serum aspartate transaminase and alanine transaminase greater than two times upper limit of normal
  • Any other co-morbidity which the physician deems as a contraindication to stem cell transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UKM Medical Centre

Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Officials

  • Hanafiah Harunarashid, MD

    UKM Medical Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanafiah Harunarashid, MD

CONTACT

+60391456208hanafiah@ppukm.ukm.my

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant Vascular Surgeon

Study Record Dates

First Submitted

October 4, 2011

First Posted

October 21, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

MY(1)