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Mesenchymal Stem Cells in the Treatment of Refractory Primary Immune Thrombocytopenia

NCT06813157 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-06

No results posted yet for this study

Summary

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

  • ITP - Immune Thrombocytopenia

Interventions

OTHER

MSC

The overall test process is as follows: screening period (V1): sign ICF, check the screening period, judge the criteria, record the baseline demographic information and the status of the subjects. Baseline period (V2): pre-transfusion assessment was performed to record the safety and other examinations of the subjects. During the treatment period (V3): according to the method and dose specified in the scheme, MSCs was treated for 5 times. Follow up period (V5): Safety and efficacy follow-up will be conducted at D14, M1, M2, M3, M6, M9, and M12 during the follow-up period.The subjects were followed up to M12 or those who met the withdrawal criteria withdrew early, whichever occurred first.

Sponsors & Collaborators

  • Guangzhou Bio-gene Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-10
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06813157 on ClinicalTrials.gov