- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07322224
Multi-Modal Longevity Protocol Including Autologous Cell-Free Conditioned Media
A Multi-Modal Longevity Protocol Integrating Lifestyle, Supplements, and Autologous Pro-Regenerative Cell-Conditioned Media: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This exploratory study investigated the biological effects of a structured, multi-modal longevity programme that included lifestyle optimisation (nutrition, exercise, sleep routines), nutritional supplementation, and autologous cell-free conditioned media (APRC-CM). APRC-CM was prepared individually for each participant from peripheral blood-derived pro-regenerative cells cultured ex vivo to produce a pro-regenerative secretome containing soluble factors and extracellular vesicles.
Participants underwent biomarker assessments at baseline and at week 17. Outcomes included measurements of epigenetic biological age, phenotypic age, inflammatory markers, metabolic markers, and other laboratory and physiological variables. The study was conducted in healthy adults and designed as a minimal-risk physiological investigation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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London, United Kingdom, W1G 0PG
- Wellbeing International Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 45 years or older
- Generally good overall health as assessed by the study team
- Able and willing to provide written informed consent
- Willing to participate in all components of the study protocol, including lifestyle optimisation, nutritional supplementation, blood collection, and scheduled follow-up visits
- Able to comply with study procedures for the duration of the intervention and assessments
Exclusion Criteria:
- Presence of a major medical condition that, in the opinion of the investigators, could affect participation or safety
- Any condition requiring hospitalization or emergency medical intervention within the past 12 months
- Receipt of anti-aging or longevity treatments within the past six months (e.g., intravenous therapies, regenerative or cellular treatments, structured age-reversal programmes)
- Active infectious disease at enrolment
- Pregnancy or breastfeeding
- Use of systemic immunomodulatory, cytotoxic, or investigational treatments in the prior 3 months
- Any condition or circumstance that, in the judgement of the investigators, may interfere with study participation or data integrity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Longevity Protocol Arm
Participants received a structured, multi-modal longevity protocol consisting of lifestyle optimization, nutritional supplementation, and autologous cell-free conditioned media (APRC-CM) prepared individually from peripheral blood-derived pro-regenerative cells.
All participants received the same intervention schedule over a 17-week period.
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The intervention consisted of a structured, multi-modal longevity program that included lifestyle optimization (nutrition, physical activity, and sleep routines), nutritional supplementation, and autologous cell-free conditioned media (APRC-CM).
APRC-CM was prepared individually for each participant from peripheral blood-derived pro-regenerative cells and administered as part of a physiologic, minimal-risk exploratory protocol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Epigenetic Biological Age
Time Frame: Baseline and Week 17
|
Biological age calculated from DNA methylation profiles using validated epigenetic clock algorithms.
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Baseline and Week 17
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Phenotypic Age
Time Frame: Baseline and Week 17
|
Phenotypic age calculated from clinical biomarkers using published phenotypic age algorithms.
|
Baseline and Week 17
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Adverse Events
Time Frame: From baseline to Week 17
|
Monitoring of any self-reported or observed adverse events throughout the study period.
Events were recorded and assessed descriptively.
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From baseline to Week 17
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Esteban Ortega, MD, Wellbeing International Foundation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BB-ART3-2024-PILOT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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