Intramuscular or combined intramuscular/intra-arterial administration of bone marrow mononuclear cells in patients with advanced limb ischaemia

Completed

• Conditions: Bone marrow mononuclear cells in patients with advanced limb ischaemia; Circulatory System; Ischaemia

• Registration Number: ISRCTN76049483
• Lead Sponsor: eiden University Medical Centre (LUMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Wound healing/limb salvage (Fontaine 3/4), measured at 6 months<br>2. Pain-free walking distance (Fontaine 2), measured at 6 months

Secondary Outcome Measures

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