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A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD

ConditionSteroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-70
SponsorAnhui Provincial Hospital

About this trial

A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Accepted systemic or local treatment of mesenchymal stem cells;

Have severe allergy to blood products or have allergy history of heterologous protein;

Expected survival period within 3 months;

Alanine transaminase(ALT)or Aspartate aminotransferase(AST)>2*upper limit of normal(ULN);Creatinine clearance rate≤30ml/min or Blood Urea Nitrogen(BUN)>2*upper limit of normal(ULN), International Normalized Ratio (INR)>1.5*upper limit of normal(ULN);

Trial design

Design model

Single group

Treatments tested in this trial

  • iMSC

    Biological/Vaccine

    Subjects will receive 4 or more times of iMSC injection

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: iMSC injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-Limiting Toxicity(DLT)

Number of Dose-limiting toxicity in 28 days after injection

Time frame
4 weeks after initial infusion
2

Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE)

Number of treatment-related adverse events,treatment emergent adverse event,treatment related adverse event or serious adverse events as assessed by CTCAE v5.0

Time frame
From the date of initial infusion to 180 days after initial infusion

Secondary outcomes

1

Objective Response Rate(ORR)

Percentage of participants achieved Complete Response(CR) or Partial Response(PR)

Time frame
28 days after initial infusion
2

Overall Survival(OS)

The time from initial infusion to death

Time frame
100 days after initial infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anhui Provincial Hospital

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)

Collaborator

Source ClinicalTrials.gov
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