Actively Recruiting
Mesenchymal Stem Cells in the Treatment of Refractory Primary Immune Thrombocytopenia
Led by Guangzhou Bio-gene Technology Co., Ltd · Updated on 2025-02-06
40
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a clinical study initiated by single-arm, single-center, multiple administration researchers. The main purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells in refractory ITP subjects. The subjects voluntarily signed the informed consent form, and after the evaluation of the screening period and the baseline period, they received 5 times of mesenchymal stem cell infusion in the treatment period, with a dose of 1 × 108/kg mesenchymal stem cells per time, with a frequency of 1 week between the first infusion and the second infusion (a time window of ±1 day), and the 3rd, 4th and 5th infusion were all 2 weeks apart from the last infusion (a time window of ±3 days). After all treatments were completed, the safety and effectiveness of D14, M1, M2, M3, M6, M9 and M12 were evaluated during the follow-up period. The subjects were followed up to M12 or those who met the withdrawal criteria withdrew early, whichever occurred first.
CONDITIONS
Official Title
Mesenchymal Stem Cells in the Treatment of Refractory Primary Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed the informed consent form
- Age between 4 and 75 years old, male or female
- Clinically diagnosed with ITP according to Chinese guidelines, with persistent thrombocytopenia lasting over 3 months
- Ineffective response to first-line drugs, second-line drugs for platelet production, rituximab, or ineffective or relapsed after splenectomy
- Maintenance regimens (such as corticosteroids, azathioprine, danazol, or mycophenolate mofetil) stable for at least 4 weeks and unchanged during the trial
- Liver function with ALT and/or AST less than or equal to 3 times the upper normal limit; total bilirubin less than or equal to 1.5 times the upper normal limit; kidney function with creatinine less than or equal to 1.5 times the upper normal limit or creatinine clearance over 75 ml/min
- Women of childbearing age must have negative pregnancy tests, not be breastfeeding, and agree to use approved contraception during the study
- Fertile male patients must agree to use barrier contraception or physical abstinence during the study
- Able to understand the trial purpose, risks, and comply with medical instructions
You will not qualify if you...
- History of severe allergic diseases or allergy to study drugs
- History of angina, heart attack, heart failure, severe arrhythmia, or similar heart conditions
- Use of anticoagulants or antiplatelet drugs
- Received gamma globulin within 2 weeks before treatment
- Received rituximab within 24 weeks before treatment
- Used other clinical trial drugs within 1 month before treatment
- Uncontrolled high blood pressure (over 160/100 mmHg) despite treatment
- History of malignant tumors
- History or current infection with hepatitis B, hepatitis C, HIV, or immunodeficiency
- Active or latent tuberculosis or other infections
- Received live attenuated vaccine within 1 month before treatment or during the study
- Low immunoglobulin levels (IgG less than 400 mg/dl or IgA less than 10 mg/dl)
- History of major organ transplantation
- History of severe mental illness
- Investigator judgment that participation is not appropriate due to other conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dongguan Taixin Hospital
Guangdong, Guangdong, China, 523125
Actively Recruiting
Research Team
C
Chaoke Bu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here