Clinical trial for the treatment of severe limb ischaemia by implantation of cultured immature red cells developed from small amount of bone marrow of the patient

Phase 1

Completed

• Conditions: Severe peripheral arterial disease including arteriosclerosis obliterans, Buerger disease and arteritis; Circulatory System; Peripheral arterial disease

• Registration Number: ISRCTN66803682
• Lead Sponsor: iigata University Medical and Dental Hospital (Japan)

Brief Summary

2018 abstract in https://www.ahajournals.org/doi/10.1161/circ.122.suppl_21.A13991 (added 12/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-18
• Study Completion: 2011-11-30
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Peripheral Arterial Disease (PAD) including Arteriosclerosis Obliterans (ASO), Buerger disease, and arteritis associated with collagen diseases
2. Fontaines stage: IIb, III, and IV
3. Chronic limb ischaemia, including rest pain, non-healing ischaemic ulcers, or both, and were not candidates for non-surgical or surgical revascularisation
4. Age: greater than 20 or less than 80 years
5. World Health Organization (WHO) performance status: 0 to 3

Exclusion Criteria

1. Patients with the expected rest of their life less than 1 year
2. Patients with drug dependence during the past 3 months
3. Patients with malignant evidence of malignant disorder during the past 5 years
4. Patients with poorly controlled diabetes mellitus accompanied with proliferative retinopathy
5. Patients with significant coronary stenosis
6. Pregnant or possibly pregnant females
7. Patients with acute myocardial infarction, unstable angina, myocarditis, or cerebral infarction during the past 1 month
8. Patients with active infection including Treponema pallidum
9. Patients with positive test for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)
10. Patients with history of allergy for antibiotics or iodo

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Efficacy evaluation: improvement in:<br> 1. Ankle-Brachial Index (ABI) (1 month of implantation)<br> 2. Transcutaneous Oxygen pressure (TcO2) (1 month)<br> 3. Rest pain<br><br> Safety evaluation:<br> 1. Adverse effects caused by the implanted cells including teratoma, ossification, etc.<br> 2. Adverse effects caysed by erythropoietin including polycythemia, hypertension, pure red cell aplasia, thrombosis in heart/lung/brain, etc.<br> 3. Adverse effects caused by possible residual components used as supplements for cell culture including allergy, serum sickness, infections, etc.<br> 4. Common adverse effects caused by drug administration stated in National Cancer Institute Common Toxicity Criteria (NCI-CTC)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Improvement in ABI (6, 12, 18 and 24 month of implantation) and Transcutaneous Oxygen pressure (TcO2) (6, 12, 18 and 24 months)<br> 2. Improvement in subjective symptoms: Visual Analogue Scale (VAS) in 1, 6, 12, 18 and 24 months of implantation<br> 3. Improvement in limb ulceration in 1, 6, 12, 18 and 24 months of implantation<br> 4. Elongation in range of pain-free walking in 1, 6, 12, 18 and 24 months of implantation<br> 5. The requirement of analgesic in 1, 6, 12, 18 and 24 months of implantation<br> 6. Manifestation of new collaterals evaluated by angiography in 1 month of implantation<br>