Umbilical Cord Blood Treatment for Refractory Immune Cytopenia

NCT04420494 | Unknown

• 1 other identifier: ZS-2433
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Umbilical Cord Blood; Refractory Immune Cytopenia

Outcome Measures

Primary Outcomes (1)

• Clinical remission rate Clinical remission rate Clinical remission rate Clinical remission rate: including CR and PR

  Units of Measure %

  0.5~24 months

Study Arms (1)

Patients treated with umbilical cord blood

EXPERIMENTAL

Other: Umbilical Cord Blood

Interventions

Umbilical Cord Blood OTHER

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.

Patients treated with umbilical cord blood

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: June 9, 2020
• Study Start: April 20, 2022
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: June 9, 2020

Record last verified: 2020-04

Locations

CN (2)