Clinical trial registry record

AllogeneiC Human Mesenchymal Stem Cells (hMSC) in Patients With Aging FRAilTy Via IntravenoUS Delivery

A registered PHASE1, PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.

Plain-language guide

Five questions to ask about this record

What this is
A clinical study registration, not a result or recommendation.
Why it may matter
The registry currently reports Completed.
Evidence
Registered phase 1, phase 2 study.
Main limitation
Registration does not prove that the intervention works, is safe, or is available to you.
What changed
Registry metadata was last updated July 14, 2021.
Where to verify
Open the primary registry below for eligibility, locations, contacts, and current status.
Registry ID
NCT02065245
Last registry update
July 14, 2021
Status
Completed
Phase
Phase 1, Phase 2
Sponsor
Longeveron Inc.
Enrollment
65
Countries
United States
Match confidence
100%
Source feed
ClinicalTrials.gov
Automated source synopsis

A registered PHASE1, PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.

Evidence snapshot

What the source actually supports

Evidence stage
Phase 1, Phase 2
Study design
RANDOMIZED · PARALLEL · TREATMENT · DOUBLE
Evidence population
Human clinical study registration
Participants
65
Population
ALL · 60 Years to 95 Years
Duration
2014-03-03 to 2020-10-02
Intervention
Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs); Placebo; Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)
Comparator
Not reported
Outcomes measured
Incidence of Any Treatment Emergent - Serious Adverse Events (TE-SAEs) — One Month post infusion; Change in Frailty as Assessed by CHAMPS Questionnaire — At baseline and 6 month follow-up visit.; Change in Slowing of Mobility as Measured by 4 Meter Gait Speed Test — At baseline and 6 month follow-up visit.; Change in Slowing of Mobility as Measured by SPPB — At baseline and 6 month follow-up visit.; Change in Weight — At baseline and 6 month follow-up visit.; Change in Diminished Hand Grip Strength — At baseline and 6 month follow-up visit.; Change in Exhaustion as Measured by the MFI Questionnaire — At baseline and 6 month follow-up visit.; Change in Quality of Life (QoL) as Measured by the ICECAP Questionnaire — At baseline and 6 month follow-up visit.; Change in Quality of Life (QoL) as Measured by the SF-36 Questionnaire — At baseline and 6 month follow-up visit.; Change in Quality of Life (QoL) as Measured by the EQ-5D-3L Questionnaire — At baseline and 6 month follow-up visit.; Change in Quality of Life (QoL) as Measured by the EQ-5D-3L Overall Health Status Scale. — At baseline and 6 month foll…; Change in Sense of Smell as Measured by UPSIT — At baseline and 6 month follow-up visit.; Death — Up to 12 months.; Change in Ejection Fraction (EF) — At baseline and 6 month follow-up visit.; Change in Inflammatory Markers Levels — At baseline and 6 month follow-up visit.; Change in Inflammatory Markers — At baseline and 6 month follow-up visit.; Change in Inflammatory Marker D-dimer Levels — At baseline and 6 month follow-up visit.
Reported result
No reusable finding-level result is available in this record.

Main limitationThis is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.

Safety and approvalEligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians. Trial registration is not regulatory approval and does not establish that an intervention is available.

Source supportStructured registry protocol metadata; no finding-level conclusion is generated.

Trial stage · Phase 1, Phase 2A trial phase describes development stage; it does not establish a positive result.
Phase 1Phase 2Phase 3Phase 4

Registration and recruitment status do not establish safety, efficacy, or regulatory approval.

Why this record appears here · 100% topic match

The title, summary, or source keywords matched one or more topics followed by immortal.life. A higher percentage means a stronger topic match; it does not rate safety, effectiveness, or study quality.

  • Stem cells · 100%Title contains controlled term: stem cell. Abstract contains controlled term: stem cell. Source terminology contains: stem cell. Title supplies longevity context: aging, frailty. Study type is explicitly identified as INTERVENTIONAL.

Automated source check 100% · update recency 50%. These figures help sort records; they are not medical ratings.