Multi-Modal Longevity Protocol Including Autologous Cell-Free Conditioned Media

NCT ID: NCT07322224

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-05
• Study Completion Date: 2025-03-20

Brief Summary

This pilot study evaluated a multi-modal longevity protocol combining lifestyle optimisation, nutritional supplementation, and autologous cell-free conditioned media derived from peripheral blood-derived pro-regenerative cells (APRC-CM). Fourteen healthy adult participants completed a 17-week programme including baseline and post-intervention biomarker assessments. The primary objective was to characterise changes in biological age using DNA methylation-based epigenetic clocks, PhenoAge and other physiological and biochemical markers.

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.

Conditions

Biological Aging; Healthy Aging; Longevity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Multi-Modal Longevity Protocol

Intervention Type: BEHAVIORAL

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.

Interventions

Multi-Modal Longevity Protocol

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

xLongevity

UNKNOWN

Sponsor Role: collaborator

Wellbeing International Foundation

UNKNOWN

Sponsor Role: collaborator

BlueBird Age Reversal SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esteban Ortega, MD

Role: PRINCIPAL_INVESTIGATOR

Wellbeing International Foundation

Locations

Wellbeing International Foundation

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

BB-ART3-2024-PILOT

Identifier Type: -

Identifier Source: org_study_id