Condition category
Circulatory System
Date applied
16/07/2007
Date assigned
16/07/2007
Last edited
04/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jan H. Lindeman

ORCID ID

Contact details

Leiden University Medical Centre
Department of Vascular Surgery
P.O. Box 9600
Leiden
2300 RC
Netherlands
Lindeman@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The primary aim of our study was to test the feasibility and safety of exclusively intramuscular, and combined intramuscular/intra-arterial delivery of Bone marrow Mononuclear Cells (BMC) in patients with advanced limb ischaemia without conventional options for surgical or endovascular treatment.

Ethics approval

Ethics approval received from the Medical Ethical Committee of the Leiden University Medical Centre on December 12, 2003 (ref: P03.149).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Bone marrow mononuclear cells in patients with advanced limb ischaemia

Intervention

Hospital admittance was planned in a short-stay setting (24 - 48 hours). The harvest procedure was performed according to standard protocols for bone marrow donation for allogenic transplantation. 750 millilitre bone marrow was collected from the posterior iliac crest under epidural or general anaesthesia. The suspension was filtered and subsequently concentrated in a final volume of 40 mL. Upon concentration of the BMC-fraction, the erythrocyte fraction was collected separately and re-infused to the patient.

The mononuclear cells were implanted approximately 4 hours after bone marrow aspiration. The method of administration was randomly assigned to the patients using a random number table:
1. By local injection into the gastrocnemius muscle
2. By combined Intramuscular (IM) and Intra-Arterial (IA) delivery

The investigators were not blinded for the assignment. In case of total IM delivery, we implanted 1 ml using a 26-gauge needle on 40 sites, 1.5 cm deep, using the full surface of the gastrocnemius muscle. In patients assigned to the combined treatment arm, the volume of each IM injection was 0.5 ml. The remaining 20 ml was slowly infused after selective catheterisation of the superficial femoral artery (or profunda femoral artery in case of occlusion of the Superficial Femoral Artery [SFA]), performed according to the standard procedures within the Department of Radiology.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Wound healing/limb salvage (Fontaine 3/4), measured at 6 months
2. Pain-free walking distance (Fontaine 2), measured at 6 months

Secondary outcome measures

1. Ankle/brachial index, measured at 3, 6 and 12 months
2. Pain scores (Brief Pain Inventory), measured at 3, 6 and 12 months
3. Quality of Life (RAND-36), measured at 3, 6 and 12 months
4. Artery scores (angiogram), measured at 6 months
5. Limb salvage/wound healing and pain free walking distance at 3 and 12 months

Overall trial start date

01/01/2004

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Disabling claudication (Fontaine’s stages IIb/III or Rutherford’s categories 3/4) or critical limb ischaemia (Fontaine’s stages IV or Rutherford’s categories 5/6) despite greater than six months optimal medical therapy
2. Ineligibility for angioplasty or bypass procedures
3. Male of female, greater than 18 years old
4. Life expectancy greater than one year
5. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25

Participant exclusion criteria

1. Candidates for angioplasty or bypass procedures
2. Inability to undergo bone marrow harvesting
3. Life threatening co-morbidity
4. International Normalised Ratio (INR) greater than 2
5. History of malignant disease in five years prior to treatment
6. Inability to undergo arterial catheterisation
7. Inability to follow the protocol and to comply with the follow up requirements
8. Any other conditions that, in the opinion of the investigators, could interfere with the therapy or could pose a significant threat to the subject if the investigational therapy was to be initiated

Recruitment start date

01/01/2004

Recruitment end date

01/01/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Centre
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (The Netherlands)

Sponsor details

Department of Vascular Surgery
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.lumc.nl/english/start_english.html

Funders

Funder type

Hospital/treatment centre

Funder name

Leiden University Medical Centre (LUMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes