MedPath

Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease

Phase 1
Conditions
Peripheral Arterial Disease (Fontaine stages three and four)
Registration Number
JPRN-UMIN000009943
Lead Sponsor
Rogenkai Welfare Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
5
Inclusion Criteria

Not provided

Exclusion Criteria

(1)The patient of hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) infection, and adult T-cell leukemia (2)The hypersensitivity to a cow or pig origin protein, the patient that has the past of side effects (3)The patient showing severe cardiac failure evidenced by cardiac echo examination. (4)Malignant diseases. (5)High-risk retinopathy (6)Serious problems of liver and renal function (7)Interstitial pneumonia. (8)Blood diseases such as anemia and leykocytosis. (9)A pregnant woman, a nursing mother, the patient that may have become pregnant, the female patient who is planning pregnancy by the end of this treatment term. (10)In addition, the patient whom the principal investigator or the researcher judged to be unsuitable based on the medical rationale

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ABI(Ankle Brechial Pressure Index): 7days, 1,6 and 12 months post transplantation. Angiography : 12 months post transplantation.
Secondary Outcome Measures
NameTimeMethod
Walking time without pain using tredmil: 1, 6 and 12 months post transplantation
© Copyright 2025. All Rights Reserved by MedPath