Autopsy report · NCT04390152

Safety and Efficacy of Intravenous Wharton's Jelly Derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Due to COVID 19

“Stopped by the IP, because the first 6 patients recruited had died and it was unknown if it represented any safety risk or if the sample was insufficient to evaluate the study hypotesis.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 4 months after it had already started.
• Ran for about 2 years 2 months before it stopped.
• 6 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 1, Phase 2

Sponsor

BioXcellerator

Sponsor type

Industry

Conditions

Acute Respiratory Distress Syndrome

Interventions

Wharton's jelly derived Mesenchymal stem cells.; Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy)

Participants

6

Sites

2

Countries

Colombia

Trials that died the same way

• Assessment of Artificial Intelligence Algorithms for ROTEM
  “The study was stopped because it was considered unlikely that the required number of patients could be prospectively recruited across the participating study centers.” (66% match in meaning)
• An Efficacy and Safety Study of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis
  “The study was stopped due to a non-clinical safety finding.” (65% match in meaning)
• Xenogenic Keratoplasty From Porcine Cornea
  “there was not enough patients recruited in this study” (64% match in meaning)
• Ischemic Stroke and Early Vertical Positioning (SEVEL)
  “The required number of patients was not reached. The sites were not able to include more patients.Despite several actions the stop of the study has been decided” (62% match in meaning)
• Pilot Study of Varenicline (Chantix®) in the Treatment of Friedreich's Ataxia
  “The DSMB recommended that the study be stopped as a result of concerns regarding safety and intolerability and insufficient evidence of efficacy.” (62% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.