The Impact of Biophoton Therapy on Self-Grown Stem Cells

NCT06855459 | Recruiting FDA Device

• 1 other identifier: FIAM-SC255
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

Study Objective The purpose of this clinical study is to evaluate if biophoton therapy, delivered by Tesla BioHealing® Biophoton Generators (Biophotonizer), can increase self-grown stem cells naturally. Study Design This is a randomized, double-blinded, placebo-controlled intervention clinical study to assess the effectiveness of biophoton therapy in impacting stem cells. Approximately 46 volunteers who want to increase self-grown stem cells will participate in the study. Study Randomization The biostatistician will prepare a randomization schedule including a serial of subject numbers. A subject number will be randomly assigned to each study participant, which will assign them to either the control group or the treatment group. Other than the Informed Consent Form (ICF), all study information will be recorded by using the subject number. The Principal Investigator, study physicians, study nurse, data-entry specialists, and biostatisticians, as well as the participants, will be blinded about who received which product during the first two weeks of study participation.

Conditions

Increase the Total Number of Stem Cells; Inflammation

Keywords

Biophoton Therapy, Tesla BioHealing, Stem Cells; Increase Stem Cells

Outcome Measures

Primary Outcomes (1)

• Changes in Self-Grown Stem Cells Count

  To determine if treatment with Biophoton Generator can impact self-grown steam cells naturally

  [Time Frame: baseline, 0-2, 0-4 weeks].

Secondary Outcomes (2)

• Quality of Life Short Form -36 (SF-36) -the function and well-being of a person

  [Time Frame: baseline, 0-2, 0-4 weeks].

• Impact of Biophoton Treatment on Pain Disability Index

  [Time Frame: baseline, 0-2, 0-4 weeks].

Study Arms (2)

Treatment

EXPERIMENTAL

This arm is to verify if biophoton generators can increase self-grown stem cells as previously observed that using Tesla BioHealers for 2 weeks the self-grown stem cells increased by 346%. BioHealing Biophotonizer-A had been used to increase is an over-the-counter (OTC) medical device and it can be used by anyone who wants to increase blood circulation and reduce bodily pains. For this study, the active Biophotonizer-A will be labeled with a code. The participant cannot know if the devices are active or inactive. When the participant places the devices close to the body, she/he may or may not receive life force energy. The participant will record changes in pain, quality of life at baseline and at the end of each week. A total of 23 participants will be enrolled in this group.

Device: Biophoton Generators

Placebo Control

PLACEBO COMPARATOR

Each participant assigned to the Control Group will be treated with the 4 placebo devices

Device: Biophoton Generators

Interventions

Biophoton Generators DEVICE

Users will be receiving biophotons emitted from the 4 devices during sleep and other time.

Placebo Control; Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give informed consent for participation in the trial.
• Is able and willing to comply with all trial requirements.
• Male or female ages 18-70 years old without major diseases.
• Participants must not be heavy users of Tesla BioHealing devices; enrollment will be determined by the clinical team based on an evaluation of the participant's prior device usage.
• Must be fluent in English.

You may not qualify if:

• Untreated psychiatric disturbances that would affect trial participation as judged by the research medical professional.
• Is participating in another investigational drug or device trial
• Had been treated with Stem Cell therapy within a 6-month period.

Sponsors & Collaborators

• First Institute of All Medicines: lead

Study Sites (2)

Tesla MedBed at Tampa-FL

Tampa, Florida, 33614, United States

RECRUITING

Tesla BioHealing Wellness Hotel - Butler-PA

Butler, Pennsylvania, 16001, United States

RECRUITING

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James Z Liu, MD, PhD

  First Institute of All Medicines

  STUDY CHAIR

Central Study Contacts

Mariola Smotrys, MD, MBA, MSc

CONTACT

(302) 500-3010; Mariola.Smotrys@firstallmed.org

Laura Poirier, BS

CONTACT

813-293-9984; laura.poirier@teslabiohealing.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each set of the study device is labelled with a unique code for use by only one participant. Participant, investigator data analyzer are all blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blinded, placebo-controlled intervention clinical study to assess the effectiveness of biophoton therapy in impacting stem cells. Approximately 46 volunteers who want to increase self-grown stem cells will participate in the study.

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 3, 2025
• Study Start: February 10, 2025
• Primary Completion: January 31, 2026
• Study Completion: March 30, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The anticipated availability period will be within 6 to 12 months after publication.
• Access Criteria: Data will be stored in a secure, recognized repository such as ClinicalTrials.gov

Locations

US (2)