NCT02032004Phase 3Completed

Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2020-01-30Actual

Enrollment · participants565Actual

Source updated2026-03-23Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-03-23 · 3 fields changed

Primary outcomes · main study measures

Text edit · unverified significance

− Previous value

measure: Time to recurrent non-fatal decompensated heart failure major adverse cardiac events (HF-MACE) that occur prior to the first terminal cardiac event (TCE).

+ Updated value

measure: Time to Recurrent Non-fatal Decompensated Heart Failure Major Adverse Cardiac Events (HF-MACE) That Occur Prior to the First Terminal Cardiac Event (TCE)

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Enrollment · participant count

Recorded edit

− Previous value

count: 566; type: ACTUAL

+ Updated value

count: 565; type: ACTUAL

Primary completion date

Recorded edit

− Previous value

2020-05-29

+ Updated value

2020-01-30

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Study details

Conditions studied

Chronic Heart Failure

Treatments or interventions studied

Rexlemestrocel-LBiologicalAlso known as Allogeneic Mesenchymal Precursor Cells

Primary outcomes · main study measures

Read the study measures

measure: Time to Recurrent Non-fatal Decompensated Heart Failure Major Adverse Cardiac Events (HF-MACE) That Occur Prior to the First Terminal Cardiac Event (TCE); description: Non-fatal decompensated heart failure (HF) event was adjudicated when the diagnosis of a nonfatal decompensated HF event demonstrated the presence of signs and symptoms consistent with clinical decompensation of the participant's HF state requiring an in-hospital stay or intravenous (IV) diuretic therapy or aquapheresis during an urgent care outpatient HF visit. TCEs were defined as a composite of cardiac death, left ventricular assist device (LVAD) placement, heart transplant, or artificial heart implantation. Adjudication of all potential non-fatal HF-MACE or TCEs was performed by an independent, blinded Clinical Endpoints Adjudication Committee (CEC) based on the cardiac adjudication manual. Negative number in the time to event range indicates that event occurred to the subject before treatment.; timeFrame: Up to 71 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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