SuspendedPhase 1/2

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

Stopped: Due to the COVID-19 pandemic, patient enrollment was slower than expected. After enrolling 26 patients, the trial was suspended as our partner company stopped producing haMPC-Exos.

China60 participantsStarted 2020-07-01

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. The patients had at least one of the following clinical manifestations:
✓. The patients had at least one of the following signs:
✓. 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.

What they're measuring

Primary Outcome Measures:

Timeframe: Up to 8 days

Trial details

NCT IDNCT04544215

SponsorRuijin Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-01

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