A Clinical Study of Mesenchymal Progenitor Cell Exosomes Nebulizer for the Treatment of Pulmonary Infection

NCT04544215 | Suspended Phase 1

• 1 other identifier: MEXDR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the efficacy and safety of haMPC-Exos treatment with pulmonary infection caused by gram-negative bacilli resistant to carbapenems.

Conditions

Drug-resistant

Keywords

human adipose-derived mesenchymal progenitor cell exosomes

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measures:

  1.Clinical cure rate on the 8th d

  Up to 8 days

Secondary Outcomes (7)

• 1.Bacterial clearance rate on the 8th d;

  Up to 8 days

• 2.Mortality on the 28th and 90th d;

  Up to 28-90 days

• 3.Recurrence rate after cure within 28 d;

  Up to 28 days

• 4.Secondary infection rate of other pathogenic bacteria after cure within 28 d;

  Up to 28 days

• 5.Duration of mechanical ventilation within 28 d;

  Up to 28 days

Study Arms (3)

MPCs-derived exosomes Dosage 1

EXPERIMENTAL

low-dose group

Biological: Dosage 1 of MPCs-derived exosomes

MPCs-derived exosomes Dosage 2

EXPERIMENTAL

high-dose group

Biological: Dosage 2 of MPCs-derived exosomes

No exosomes

PLACEBO COMPARATOR

No MPCs-derived exosomes

Biological: No MPCs-derived exosomes

Interventions

Dosage 1 of MPCs-derived exosomes BIOLOGICAL

7 times aerosol inhalation of MPCs-derived exosomes (8.0\*108 nano vesicles/3 ml at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7).

MPCs-derived exosomes Dosage 1

Dosage 2 of MPCs-derived exosomes BIOLOGICAL

7 times aerosol inhalation of MPCs-derived exosomes (16.0\*108 nano vesicles/3 ml at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7).

MPCs-derived exosomes Dosage 2

No MPCs-derived exosomes BIOLOGICAL

No aerosol inhalation of MPCs-derived exosomes

No exosomes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1.Willingness of study participant to accept this treatment arm, and signed informed consent; 2.Male or female, aged at 18 years (including) to 75 years old; 3.Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), was diagnosed within 48 h. The diagnosis must simultaneously comply with the three clinical and radiological criteria described below, which occurred more than 2 d (48 h) after hospitalization, within 7 d after discharge (HAP) or at least 2 d (48 h) after mechanical ventilation (VAP):
• The patients had at least one of the following clinical manifestations:
• New or deteriorating pulmonary symptoms or signs, such as cough, dyspnea, shortness of breath (e.g., respiratory rate higher than 25 beats/min), expectoration or need for mechanical ventilation;
• Hypoxemia (e.g., when subjects breathe room air at standard atmospheric pressure, the partial pressure of oxygen measured as lower than 60 mmHg by arterial blood gas \[ABG\], or the ratio of partial pressure of oxygen to fraction of inspired oxygen \[PaO2/FiO2\] deteriorated);
• According to the deterioration of oxygenation (ABG or PaO2/FiO2), the support system for the ventilator should be replaced urgently to strengthen oxygenation, or the positive end-expiratory pressure level should be changed;
• Aspirable respiratory secretions newly appeared;
• The patients had at least one of the following signs:
• Confirmed fever (e.g., body temperature ≥ 38.4℃);
• Hypothermia (e.g., body temperature ≤ 35℃);
• Total peripheral white blood cell (WBC) count ≥ 11 × 109/L;
• Leukopenia, and total WBC ≤ 4 × 109/L;
• Immature neutrophils (rod-shaped nuclear cells) \> 15% was observed on peripheral blood smears;
• The chest X-ray of the patients showed new or progressive infiltration, and pneumonia was considered.
• The pathogenic test of the lower respiratory tract specimens revealed carbapenem-resistant Gram-negative bacilli (Pseudomonas aeruginosa, Klebsiella pneumoniae or Acinetobacter baumannii), which were consistent with the drug resistance spectrum and intermediate or resistant to all carbapenem antibiotics, namely, the minimum inhibitory concentration (MIC) of meropenem or imipenem ≥ 2 μg/ml (2 μg/ml was intermediate and 4 μg/ml was drug-resistant). The MIC of ertapenem ≥ 1 μg/ml, of which 1 μg/ml was intermediate and ≥ 2 μg/ml was drug-resistant.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Shanghai AbelZeta Ltd.: collaborator

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 10, 2020
• Study Start: July 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication

Locations

CN (1)