Evaluate efficacy and safety of umbilical cord-derived mesenchymal stromal cells (HLC-001) for patient with Noninfectious lung complications after allogeneic haematopoietic stem cell transplantation

JRCT ID: jRCT2063220014

Registered date:10/05/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-infectious Pulmonary Complications, Idiopathic Pneumonia Syndrome
• Date of first enrollment: 21/10/2022
• Target sample size: 12
• Study type: Interventional

Intervention(s)

To evaluate the efficacy and safety of HLC-001(umbilical cord mesenchymal stem cell)
Dose:2x10^6 cells /kg, One cycle is defined as twice a week intravenous administration(four times in total). Up to two cycles of administration (four cycles at a maximum, eight times in total ) is allowed for subjects with no significant adverse events and not-sufficient response .

Outcome(s)

• Primary Outcome: Overall survival rate on 56 days after the treatment

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients to meet the IPS criteria by American Thoracic Society
2. Patients that the disease worsens after the treatment of more than 1mg/kg/day of corticosteroid (prednisolone equivalent) for 3 days or later, or patients that do not improve the disease after the treatment of more than 1 mg/kg/day of corticosteroid for 5 days
3. 16 years or older when informed consent is obtained

Exclude criteria

1.Evidence of active infectious pneumonitis
2.Respiration failure due to cardiac arrest (Enlargement of heart mental shadows and left ventricular ejection fraction that is less than 45%)
3.Patients that received or has received the following medications for concurrent diseases
1)Bone Marrow-derived Mesenchymal Stem Cell
2)Inhibitor of Bruton tyrosine kinase (BTK)
Or patients that clearly need the following medications, therapies after enrollment
1)Other systemic immunosuppressant medical treatments
2)Increment of corticosteroid except for the use as needed for allergic reaction
4.Patients that received therapies for cancer within 3 months of enrollment except for hematopoietic cell transplantation or patients with unstable condition of cancer although therapies were completed more than 3 months before enrollment
5.History of acute myocardial infarction within 3 months before enrollment
6.Medical History or complication of primary pulmonary hypertension
7.The following laboratory test result within 14 days before enrollment except for abnormality to be caused by GVHD
1)Serum total bilirubin (TB), 3 times of upper limit of institutional normal range
2)Aspartate aminotransferase (AST)and Alanine aminotransferase (ALT), 5 times of upper limit of institutional normal range
3)Serum creatinine, 2 times of upper limit of institutional normal range

Related Information

• Primary Sponsor: Morio Ikeda