Systemic sclerosis skin lesions of the hand
Conditions
Interventions
iow-dose group:Human adipose mesenchymal stem cell injection
medium-dose group:Human adipose mesenchymal stem cells injection
high-dose group:Human adipose mesenchymal stem cells injection
Sponsors
Beijing Union Medical College Hospital of the Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-60 years old (including the critical value), gender is not limited; (2) Systemic sclerosis according to the 2013 American College of Rheumatology/European Alliance against Rheumatism.The diagnostic criteria for SSc (see Annex 1) are diffuse skin type or Limited skin type (? no clinical manifestations of new organ involvement; ? Original involvement the clinical manifestations of organs are stable); (3)CHFS=20 (total score 90), with or without skin ulcers; (4) Oral low-dose glucocorticoid therapy (prednisone =10mg/ day) was allowed before enrollment or equivalent dose), provided that the stabilizer has been applied for =8 weeks and maintained at the time of enrollment dose =28 days; (5) Good compliance, able to understand and cooperate to complete the corresponding inspection operation, willing to press subjects who take medication as required by the protocol and receive follow-up examinations on time; (6) Subjects who voluntarily participate in the experiment, understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) The skin lesions of the hand were in the atrophy stage; (2) Progression of systemic lesions within three months, such as increased shortness of breath after activity, acute renal insufficiency and other manifestations, requiring adjustment of immunotherapy drugs or hospitalization; (3) Combined with other diseases not suitable for surgery, such as serious cardiovascular and cerebrovascular diseases, infectious diseases, coagulation dysfunction, etc.; (4) Overlap with other rheumatic immune diseases, such as RA, SLE, dermatomyositis, etc. (except for those whose original rheumatic immune diseases do not involve the hand and do not affect the safety and efficacy evaluation of the hand); (5) Oral prednesone > 10mg/ day (or equivalent dose) at the time of enrollment, or maintenance of stable dose for less than 28 days, or cessation of oral glucocorticoids for less than 14 days, or intravenous glucocorticoids had been used within 14 days before enrollment; (6) Stable dose of antimalarial drugs such as hydroxychloroquine or plant preparations such as tripterygium glycosides was maintained for less than 3 months, or stopped for less than 14 days; (7) have previously received stem cell therapy, or are intolerant to cell therapy; (8) Patients who received CD20 MAB treatment within 1 year; (9) Patients who have used biologics and small molecule targeted drugs within 3 months of the screening period; (10) Malignant tumors occurred within 5 years before screening; Or abnormal tumor marker detection, and the investigator determined that there is a tumor risk; (11) There is evidence that the subject currently has digestive, urinary, cardiovascular, cerebrovascular, blood, nervous, mental and metabolic diseases that may affect safety, such as diabetes with poorly controlled blood sugar, hypertension with poorly controlled blood pressure, etc.; (12) Have a history of psychotropic drug abuse or drug use; (13) Any of the following laboratory test results were present at the time of screening: hemoglobin 1.5× upper limit of normal (ULN) during screening; Total bilirubin was >1.5×ULN during screening. An estimated glomerular filtration rate (GFR) of <40mL/min/1.73m2, or any uncontrolled, clinically significant laboratory abnormalities that may affect the interpretation of study data or participants' participation in the study; (14) Serum virology (HBsAg, HCV antibody, HIV antibody, treponema pallidum antibody) test positive, Among them, hepatitis B virus carriers, stable hepatitis B patients after drug treatment (HBV DNA < 2000 IU/mL or 10,000 copies/mL) and cured hepatitis C patients (HCV RNA test negative) could be enrolled after the investigators judged qualified; (15) Those who are allergic to any of the components of human blood albumin, narcotic drugs or human adipose mesenchymal stem cell injection, or have a history of severe allergy that the researcher determines is not suitable for inclusion; (16) Participants who participated in any other clinical trial within 3 months prior to screening; (17) Those judged by the investigator to be at higher risk for local anesthesia; (18) Women who are pregnant or nursing, or who test positive for human chorionic gonadotrophin beta (ß-HCG) during the screening period, or who are unable and unwilling to use effective n
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint;Tumor marker examination;Immunogenicity test;High resolution CT of the lungs;B-type ultrasonic; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Cochin Hand Function Scale score (CHFS) from baseline;Changes in hand HAMIS from baseline;;Changes from baseline in skin ultrasound and nail fold microcirculation examination of the hand;Changes in whole-body modified Rodnan skin thickness score (mRSS) from baseline;;Changes from baseline in visual analogue Scale (VAS) pain score, Raynaud's condition score (RCS) and Clinical Assessment Scale for Finger ulcer;;Changes in the Systemic Sclerosis Related Health Rating Scale (SHAQ) from baseline; | — |
Countries
China
Contacts
Public ContactXiao Long
Peking Union Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed