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A prospective, single-center study for the efficacy and safety of umbilical cord-derived mesenchymal stem cells as a substitute or partial substitute for calcineurin inhibitors in children with post-transplant calcineurin inhibitor intolerance

A prospective, single-center study for the efficacy and safety of umbilical cord-derived mesenchymal stem cells as a substitute or partial substitute for calcineurin inhibitors in children with post-transplant calcineurin inhibitor intolerance

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025689
Enrollment
Unknown
Registered
2019-09-05
Start date
2019-09-06
Completion date
Unknown
Last updated
2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GvHD

Interventions

1:Intermittent infusion of mesenchymal stem cells

Sponsors

General Hospital of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. 0-14 years old with allogeneic hematopoietic stem cell transplantation; 2. Patients diagnosed as calcineurin intolerance or low dose tolerance (cyclosporine Valley concentration < 50ng/ml, tacrolimus Valley concentration < 5.0ng/ml).

Exclusion criteria

Exclusion criteria: 1. Patients with aGVHD above III or chronic extensive GVHD before admission. 2. In the presence of patients with severe organ failure, the researchers do not think it is suitable for this experiment. 3. Patients with recurrence or relapse tendency of malignant diseases. 4. Severe infection exists, which is not suitable for the experiment. 5. Patients who refuse to sign informed consent.

Design outcomes

Primary

MeasureTime frame
GVHD;Organ toxicity;

Secondary

MeasureTime frame
T B lymphocyte subsets;Dosage of glucocorticoid;Rehabilitation of damaged organs in original CNI;Disease status of malignant diseases;

Countries

China

Contacts

Public ContactRongmu Luo
luorongmu@163.com+86 15001149969

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026