Safety and Efficacy of UC-MSC in Patients With Acute Severe Graft-versus-host Disease

Launched by AFFILIATED HOSPITAL TO ACADEMY OF MILITARY MEDICAL SCIENCES · Dec 18, 2012

Keywords

ClinConnect Summary

The mesenchymal stem cells (MSC) is a class of low immunogenicity from mesoderm, had the self-renewal and differentiation potential as pluripotent stem cells. The umbilical cord is one of the important sources of MSC. Human UC-MSC compared with the bone marrow-derived MSC has the following advantages: (1) the umbilical cord, as a "waste" after giving birth can be obtained without any harm to the donor. (2) easy available, and no ethical issues. (3) its likelihood of contamination is small because of the protection of the placental barrier. (4) human UC-MSC has a stronger amplification capac...

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Eligibility criteria

• Inclusion Criteria:
• • aged 18-70 years
• • undergoing allogeneic hematopoietic stem cell transplant recipients
• • post-transplant acute GVHD (Ⅲ \~ Ⅳ degrees)
• • the effects of other immunosuppressive therapy
• • glucocorticoid resistance or glucocorticoid therapy invalid
• • cooperation observed adverse events and efficacy
• • patients understand the status of the experimental observations, with the doctor's treatment and post-treatment follow-up, patients or their legal representatives signed a written informed consent
• Exclusion Criteria:
• • had severe allergy history
• • within three months to participate in other medical or drug trials
• • as a subjects was sampled within three months
• • smoking, alcohol and drug abusers
• • suffers from an important organ of primary disease (heart, liver, kidney, lung, brain, etc.), infectious diseases (including HIV and suspicious latent infection), people with disabilities and / or mental disorders
• • to judge according to the researchers, the subjects could not complete the study or may not be able to comply with the requirements of this study (due to administrative reasons or other reasons)
• Exit criteria:
• • In clinical trials, the participants had some complications, complications or special physiological changes, unfit to continue to accept the test
• • subjects with poor compliance, affect the determination of the pharmacokinetic results
• • subjects using the drugs may affect the results of the pharmacokinetic
• • the occurrence of serious adverse events in subjects
• • subjects withdrew informed consent, or withdraw from the trial itself
• Termination criteria:
• • serious adverse events (except the researchers judgment and research drugs must be independent), should stop all test
• • found that clinical research plan has important lapses, difficult to evaluate the effects of drugs, or a better design in implementation had an important deviation, difficult to continue to evaluate the effects of drugs
• • sponsor for the request to terminate (such as funds reason, management reason, etc.)
• • state food and drug administration for some reason ordered to terminate test
• Exclusion criteria:
• • does not meet the entry criteria
• • exclusion criteria
• • once the drug is not used in
• • no records