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Umbilical Cord Blood Treatment for Refractory Immune Cytopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04420494
Recruitment Status : Unknown
Verified April 2020 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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Brief Summary:
Immune-related hematocytopenia is a type of immunity Inflammatory cytopenia-mediated diseases, hormones and immunosuppressants are its first-line treatment. However, conventional immunosuppressants are ineffective or have a high recurrence rate. And some patients are not effective for these treatments, due to infection of blood cells, bleeding, decreased quality of life, and even severe death. There is currently no effective method for such patients. This study intends to recruit IRIC patients, give cord blood infusion, observe its efficacy and safety, and detect changes in inflammation-related indicators before and after treatment. There are no relevant reports at China and abroad. This study can provide new treatment options for patients with IRIC.

Condition or disease Intervention/treatment Phase
Umbilical Cord Blood Refractory Immune Cytopenia Other: Umbilical Cord Blood Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Umbilical Cord Blood Treatment for Refractory Immune Cytopenia: a Single-arm Prospective Study
Estimated Study Start Date : April 20, 2022
Estimated Primary Completion Date : April 20, 2022
Estimated Study Completion Date : April 20, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients treated with umbilical cord blood Other: Umbilical Cord Blood
The diagnosis is definitely immune cytopenia (IRC), including autoimmune hemolytic anemia (AIHA, Hgb <100g / L, acquired pure red aplastic anemia (PRCA, Hgb <100g / L, EVANS syndrome , Hgb <100g / L and / or platelet count <30 × 109 / L, or blood cell reduction secondary to immune diseases (the same as the treatment indications, or neutrophils <0.5 × 109 / L), at least after hormone therapy Patients who are ineffective (did not reach PR after 4 weeks of hormone therapy) or who have not achieved PR after 3-5 mg / kg / d of cyclosporine. These patients would be treated with umbilical cord blood.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical remission rate Clinical remission rate Clinical remission rate Clinical remission rate: including CR and PR [ Time Frame: 0.5~24 months ]
    Units of Measure %


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-80 years (adults, elderly), gender is not limited;

    • The diagnosis is definitely immune cytopenia (IRC), including autoimmune hemolytic anemia (AIHA, Hgb <100g / L, acquired pure red aplastic anemia (PRCA, Hgb <100g / L, EVANS syndrome ES, Hgb <100g / L and / or platelet count <30 × 109 / L, or cytopenia secondary to immune diseases (same treatment as before, or neutrophils <0.5 × 109 / L), at least after hormones If the treatment is not effective (PR has not been achieved after 4 weeks of hormone therapy) or cyclosporine 3-5mg / kg / d has not reached PR for half a year.

      • Those without abnormal cardiac function, abnormal liver function (total bilirubin 1.5 × ULN, ALT, AST≤3.0 × ULN), and abnormal renal function (serum creatinine≤1.0 × ULN) ④ ECOG score 0, 1 or 2; ⑤ Except autoimmunity There is no other secondary disease other than the disease; ⑥ Clearly understand the content of the trial, voluntarily participate in and complete this trial, and voluntarily sign an informed consent.

Exclusion Criteria:

  • Age <18 years old or> 80 years old;

    • Patients with tumors (except carcinoma in situ); ③ Uncontrollable systemic infections or other serious diseases; ④ Women who are pregnant or lactating; ⑤ Patients with mental illness and potential impact Those with severe mental and mental illness who signed the informed consent form and followed up with the medical consultation;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04420494


Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Yali Y Du, master    +8618910575941    yali_crazy@126.com   
China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Yali Du, Master    +8618910575941    yali_crazy@126.com   
Principal Investigator: Bing Han, Doctor         
Sponsors and Collaborators
Peking Union Medical College Hospital
More Information
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04420494    
Other Study ID Numbers: ZS-2433
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia
Leukopenia
Thrombocytopenia
 Hematologic Diseases
Leukocyte Disorders
Blood Platelet Disorders