Systemic sclerosis Systemic sclerosis, Vasculopathy, Skin ulcer, Raynaud's phenomenon
Conditions
Interventions
Therapeutic angiogenesis, Cell transplantation, Bone marrow-derived mononuclear cell, Endothelial progenitor cell
Sponsors
Yoshimi Ryusuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Include patients who meet all of the selection criteria (1) to (8). (1) Patients with a total of 9 or more ACR/EULAR systemic sclerosis criteria at the time of diagnosis, and who have been clinically diagnosed with systemic sclerosis by a physician. (2) Patients who are at least 20 years old and under 80 years old at the time of obtaining written consent (irrespective of gender). (3) Patients who have intractable skin ulcers associated with systemic sclerosis and whose ulcer area reduction rate is less than 20% during the 12-week observation period before registration. (4) Patients who are judged to be inadequately effective after treatment for the past 12 weeks or more with a standard treatment approved by the public health insurance for skin ulcers associated with systemic sclerosis. (5) Patients who have not performed split-thickness skin grafting or limb amputation for skin ulcer/gangrene. (6) Patients holding limbs. (7) Patients who have not been treated with therapeutic angiogenesis similar to this study. (8) Patients who have given written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Subjects who do any of the following must not be included: (1) Life expectancy is less than one year due to other complications. (2) When there is a malignant tumor that has not been determined to be cured. (3) If there is ischemic heart disease and blood circulation has not been reconstructed. (4) If the HbA1c (NGSP) value within 10 days before registration is 10% or more, or if there is diabetic retinopathy. (5) If there is an infection requiring systemic treatment or have a fever of 38.0 degrees C or more at the time of registration. (6) If the laboratory test within 28 days before registration falls under the following or is a dialysis patient. a) AST: 100 U/L or more, b) ALT: 100 U/L or more, or c) eGFR: less than 25 mL/min/1.73m2. (7) When there are severe blood diseases such as leukopenia and thrombocytopenia and severe anemia requiring blood transfusion. (8) If patients are pregnant, nursing, may be pregnant or wish to become pregnant. (9) Participation in clinical trials or clinical trials of drugs or medical devices within 28 days before registration in this study, and undergoing intervention such as test drugs. (10) If there are other severe acute or chronic medical or mental conditions or abnormal laboratory values that may increase the risk of participating in the study or affect the interpretation of the study results. (11) Patients who cannot escape amputation of the affected limb regardless of the success or failure of this treatment due to evidence of osteonecrosis or bone/tendon exposure in the ulcer/necrotic lesion before registration. (12) Besides, when the chief investigator or the investigator judges that participation in this study is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective treatment rate | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Number of skin ulcers (2) Number of new skin ulcers (3) The change rate of skin ulcer area (4) Presence of cyanose (5) The severity of Raynaud's phenomenon by Raynaud's Condition Score (6) Pain evaluation by the visual analog scale (7) Impairment assessment by health assessment questionnaire (8) Amputation of the affected limb and the period until amputation (9) Overall survival time | — |
Countries
Japan
Contacts
Public ContactRyusuke Yoshimi
Yokohama City University Hospital
Outcome results
None listed