JPRN-jRCTb032210204
Recruiting
未知
Therapeutic angiogenesis in patients with systemic sclerosis by autologous transplantation of bone marrow-derived mononuclear cells - TASSCAT-BM-MNC
Yoshimi Ryusuke0 sites12 target enrollmentJuly 19, 2021
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Systemic sclerosis
- Sponsor
- Yoshimi Ryusuke
- Enrollment
- 12
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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