Autopsy report · NCT01019681

Efficacy and Safety of Umbilical Cord Blood Injection for Critical Limb Ischemia

“Only patient enrolled on study died -the cause of death not study related”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 4 years 2 months before it stopped.
• 1 participant enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 1

Sponsor

Richard Burt, MD

Sponsor type

University, hospital or other

Conditions

Critical Limb Ischemia

Interventions

Cord blood stem cell injection

Participants

1

Sites

1

Countries

United States

Trials that died the same way

• A Study of CCCTC-binding Factor (CTCF) in Infantile Hemangiomas
  “no subjects were enrolled, study was halted due to study staff departure” (67% match in meaning)
• Evaluate the Performance of JOURNEY II CR and JOURNEY II BCS in TKA Populations
  “Study design is not reasonable and sponsor decided to terminate the study. No patient enrolled by now” (66% match in meaning)
• The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active "Drug: Crohn's Disease"
  “Study terminated due to lack of eligible patients” (66% match in meaning)
• Hematopoietic Stem Cell Transplantation (HSCT) Using CD34 Selected Mismatched Related Donor and One Umbilical Cord Unit
  “Only one patient was enrolled. Due to low accrual study was terminated” (66% match in meaning)
• Cannabinoids in Bipolar Affective Disorder
  “study was never started and no patients were ever enrolled” (66% 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.