Biophoton Therapy for Stem Cell Proliferation

(Stem Cells Trial)

Recruiting at 1 trial location

Overseen By Laura Poirier, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: First Institute of All Medicines

Disqualifiers: Untreated psychiatric disturbances, others

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if biophoton therapy, using the Tesla BioHealing® Biophoton Generator, can naturally boost stem cell growth in the body. Participants will be randomly assigned to receive either active therapy or a placebo (inactive treatment) and will track changes in pain and quality of life over two weeks. This trial may suit individuals who are generally healthy, have no major diseases, and are interested in increasing stem cell production. As an unphased trial, this study offers a unique opportunity to explore innovative therapy and contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the clinical team for guidance.

What prior data suggests that biophoton therapy is safe for increasing self-grown stem cells?

Research has shown that biophoton therapy, using devices like the Tesla BioHealing® Biophotonizer, is generally well-tolerated. Past studies have used it as an over-the-counter device to improve blood flow and reduce pain without major issues.

Animal studies revealed that long-term use on bone marrow did not cause harm. Tests with cells similar to human cells indicated that lower doses were safe, while higher doses could be risky. This suggests the therapy is safe when used correctly.

Overall, biophoton therapy appears to be a promising and safe option. However, as with any new treatment, monitoring for side effects is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Biophoton Therapy is unique because it uses life force energy to potentially boost stem cell production, which is different from traditional methods like medication or surgical interventions. Most conventional treatments for increasing stem cells focus on direct cell transplantation or using chemicals to stimulate growth. This therapy involves an over-the-counter device, the Biophotonizer-A, which is non-invasive and aims to enhance blood circulation and alleviate pain. Researchers are excited because if effective, it could offer a simpler, more accessible way to harness the body’s natural healing processes without the need for complex medical procedures.

What evidence suggests that biophoton therapy is effective for increasing self-grown stem cells?

Research has shown that biophoton therapy, which participants in this trial may receive, can significantly enhance the growth of stem cells produced by the body. Specifically, earlier studies found that using Tesla BioHealers led to a 346% increase in these cells over two weeks. This therapy boosts cellular energy, potentially reducing fatigue and improving overall vitality. With increased energy, the body might naturally produce more stem cells. Although further research is needed, these early findings offer promise for those seeking to increase their stem cell count. ^{1 2 3 6 7}

Who Is on the Research Team?

James Z Liu, MD, PhD

Principal Investigator

First Institute of All Medicines

Are You a Good Fit for This Trial?

This trial is for volunteers who want to increase their self-grown stem cells. Participants must meet certain health criteria, but specific inclusion and exclusion details are not provided.

Inclusion Criteria

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

Willing and able to give informed consent for participation in the trial

Is able and willing to comply with all trial requirements

Exclusion Criteria

Untreated psychiatric disturbances that would affect trial participation as judged by the research medical professional

Is participating in another investigational drug or device trial

I have received stem cell therapy in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants receive biophoton therapy or placebo for 2 weeks, with nightly use of devices for at least 8 hours

2 weeks

Weekly assessments (virtual)

Placebo Extension

Participants in the placebo group may switch to active treatment for an additional 2 weeks

2 weeks

Weekly assessments (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Biophoton Therapy

Trial Overview The study tests if Tesla BioHealing® Biophoton Generators can boost natural stem cell growth. It's a randomized, double-blinded, placebo-controlled trial with participants unaware of whether they're receiving the real treatment or a placebo.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

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.

Group II: Placebo Control Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

First Institute of All Medicines

Lead Sponsor

Trials

4

Recruited

220+

Published Research Related to This Trial

This study successfully demonstrated that gamma radiation can induce biophoton emissions in HCT116 p53+/+ cells, marking a significant advancement in understanding the effects of gamma radiation on biological systems.

The research found that these cells emitted 2.5 times more UVA biophotons compared to 610-nm biophotons, suggesting that UVA emissions may play a crucial role in the bystander effects observed after gamma irradiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying Biophoton Emissions From Human Cells Directly Exposed to Low-Dose Gamma Radiation. Cohen, J., Vo, NTK., Chettle, DR., et al.[2020]

High-intensity red LED irradiation significantly enhances the osteogenic differentiation and mineralization of human bone marrow mesenchymal stem cells (BMSCs) when exposed to 6 J/cm2 for 30 seconds, without affecting cell proliferation over 72 hours.

The mechanism behind this enhancement involves the activation of the Wnt/β-catenin signaling pathway, as evidenced by the suppression of these effects when a Wnt/β-catenin inhibitor was applied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irradiation by high-intensity red light-emitting diode enhances human bone marrow mesenchymal stem cells osteogenic differentiation and mineralization through Wnt/β-catenin signaling pathway. Ruan, Y., Kato, H., Taguchi, Y., et al.[2021]

Light irradiation can significantly enhance the proliferation and differentiation of stem cells, but the optimal parameters depend on the specific cell type being treated.

High power density and low energy density with short exposure times are most effective for increasing stem cell responses, while different parameters are required for maximizing proliferation versus differentiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photomodulation of proliferation and differentiation of stem cells by the visible and infrared light. Emelyanov, AN., Kiryanova, VV.[2018]

Low-level laser therapy (LLLT) applied to the bone marrow in mice showed no harmful effects on major organs such as the liver, kidneys, brain, or bone marrow itself, indicating its long-term safety.

The study, which involved 83 mice monitored for 8 months, found no signs of tissue damage or abnormal growths (neoplasms) in response to various doses of LLLT, suggesting that it can be safely used to stimulate stem cell activity without adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of low-level laser therapy at different power densities and single or multiple applications to the bone marrow in mice. Tuby, H., Hertzberg, E., Maltz, L., et al.[2018]

Irradiating Escherichia coli with 632.8 nm light at a dose of 4 J cm-2 leads to a temporary boost in cell growth, peaking about 60 minutes after treatment, particularly in defective strains during their logarithmic growth phase.

The light treatment causes significant biochemical and morphological changes in the bacteria, including increased synthesis of membrane proteins and cell volume, indicating enhanced metabolic activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biochemical and morphological changes in Escherichia coli irradiated by coherent and non-coherent 632.8 nm light. Bertoloni, G., Sacchetto, R., Baro, E., et al.[2019]

Low-level visible light irradiation significantly enhances the proliferation of mesenchymal stem cells (MSCs), nearly doubling their number compared to control groups in vitro.

The study found that this light exposure also increases the production of reactive oxygen species and nitric oxide in MSC cultures, suggesting a potential mechanism for the observed cell growth, which could be beneficial for applications in wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level visible light (LLVL) irradiation promotes proliferation of mesenchymal stem cells. Lipovsky, A., Oron, U., Gedanken, A., et al.[2021]

Low-level laser therapy at a dose of 10 J/cm2 significantly enhances the viability and DNA content of osteoblast-like cells, indicating a biostimulatory effect that could promote bone remodeling.

Higher doses of 20 to 50 J/cm2 were found to be cytotoxic, reducing cell viability and DNA content, which suggests that careful dose management is crucial for effective therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different doses of low-level laser irradiation modulate the in vitro response of osteoblast-like cells. Incerti Parenti, S., Checchi, L., Fini, M., et al.[2019]

Red-light low-level light irradiation (LLLI) significantly enhances the proliferation of rat mesenchymal stem cells (MSCs), especially at lower cell densities, with optimal results achieved through multiple exposures at specific irradiance and radiant exposure levels.

LLLI also boosts the osteogenic differentiation of MSCs, as indicated by increased expressions of alkaline phosphatase and osteocalcin, suggesting its potential for enhancing bone regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Red-light light-emitting diode irradiation increases the proliferation and osteogenic differentiation of rat bone marrow mesenchymal stem cells. Li, WT., Leu, YC., Wu, JL.[2018]

Photobiomodulation (PBM) using InGaAlP diode laser at doses of 2.5 J/cm2 and 3.7 J/cm2 significantly improved the proliferation and viability of stem cells from human exfoliated deciduous teeth (SHED) after 24 hours.

PBM also enhanced the synthesis of angiogenic proteins like VEGF-C, VEGF-A, and PLGF in the supernatant, indicating a potential mechanism for promoting tissue regeneration and healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Angiogenic protein synthesis after photobiomodulation therapy on SHED: a preliminary study. Oliveira Prado Bergamo, MT., Vitor, LLR., Lopes, NM., et al.[2020]

Low level laser (LLL) irradiation has been used for decades to promote tissue healing and reduce inflammation, showing potential as a non-invasive method to enhance stem cell therapies.

LLL irradiation may boost the production of growth factors, stimulate new blood vessel formation (angiogenesis), and directly increase stem cell proliferation, making it a promising adjunct to both allogeneic and autologous stem cell treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lasers, stem cells, and COPD. Lin, F., Josephs, SF., Alexandrescu, DT., et al.[2021]

The combination of He-Ne laser biostimulation and Polygen (PG) significantly enhances the proliferation of Chinese hamster ovary (CHO) cells, with the laser increasing colony formation by 13.2% and PG by up to 19.2%.

Using both the He-Ne laser and PG together resulted in even greater stimulation of cell growth, with increases of 23.2% and 20.5% for the respective PG concentrations, suggesting that this combination could be a promising new treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of He-Ne laser (632.8 nm) and Polygen on CHO cells. Al-Watban, FA., Andres, BL.[2015]

In a study involving 73 cancer patients undergoing radiotherapy, the Photobiomodulation protocol in Group 1 (660 nm, 15 mW, 3.8 J/cm2) was found to significantly delay the onset of grade II oral mucositis compared to the other protocols, indicating its superior efficacy.

Patients in Group 1 also reported lower pain scores related to oral mucositis, suggesting that this Photobiomodulation protocol not only reduces the severity of mucositis but also alleviates associated pain more effectively than the other treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three photobiomodulation protocols in the prevention/treatment of radiotherapy-induced oral mucositis. de Carvalho, PAG., Lessa, RC., Carraro, DM., et al.[2021]

Photobiomodulation therapy significantly enhances bone repair in critical surgical wounds when combined with bone morphogenetic proteins (BMPs) and biological membranes, as shown in a study with 32 male rats over 30 days.

Histological and histomorphometric analyses revealed that the combination treatment resulted in higher quality and quantity of bone neoformation compared to the control group, indicating its potential efficacy in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation Therapy in Bone Repair Associated with Bone Morphogenetic Proteins and Guided Bone Regeneration: A Histomorphometric Study. Gerbi, MEMM., Miranda, JM., Arruda, JAA., et al.[2019]

This study successfully used biophoton emission imaging to monitor tumor growth in mice, demonstrating that biophoton intensity correlates with tumor size and viability, with a correlation coefficient of 0.73.

The technique offers a non-invasive method for assessing tumor viability, suggesting its potential as an optical biopsy tool in cancer research and treatment monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biophoton detection as a novel technique for cancer imaging. Takeda, M., Kobayashi, M., Takayama, M., et al.[2019]

A new non-invasive optical method using a femtosecond laser can effectively induce stem cell differentiation, specifically turning adipose-derived stem cells into osteoblasts without the risk of off-target effects.

This technique not only works in laboratory settings but can also direct the differentiation of neuronal progenitor cells in living mice, highlighting its potential for safe and precise applications in regenerative medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stem cell differentiation with consistent lineage commitment induced by a flash of ultrafast-laser activation in vitro and in vivo. Tang, W., Wang, H., Zhao, X., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06855459

The Impact of Biophoton Therapy on Self-Grown Stem Cells Study Objective The purpose of this clinical study is to evaluate if biophoton therapy, delivered by Tesla BioHealing® Biophoton Generators (Biophotonizer), ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06855459/the-impact-of-biophoton-therapy-on-self-grown-stem-cells

The Impact of Biophoton Therapy on Self-Grown Stem Cells The purpose of this clinical study is to evaluate if biophoton therapy, delivered by Tesla BioHealing® Biophoton Generators (Biophotonizer), can increase self- ...

3. withpower.com withpower.com/trial/phase-inflammation-1-2025-b01d6

Biophoton Therapy for Stem Cell Proliferation Trial Overview The study tests if Tesla BioHealing® Biophoton Generators can boost natural stem cell growth. It's a randomized, double-blinded, placebo- ...

4. fda.gov fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tesla-biohealing-inc-658010-08102023

Tesla BioHealing, Inc. - 658010 - 08/10/2023 Increases ATP levels, reducing fatigue and boosting vitality. Increases cellular energy up to the optimal range of (b)(4). Generates stem ...

5. trial.medpath.com trial.medpath.com/clinical-trial/fdbaebc5172d1133/nct06915012-biophoton-therapy-chronic-arthritis-pain

Impact of Biophoton Therapy on Chronic Severe Arthritis Pain Study Objective The purpose of this clinical study is to evaluate if biophoton therapy, delivered by Tesla BioHealing® Biophoton Generators ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07124208

A Randomized Double-Blinded and Placebo-Controlled ... Study Design This is a randomized, double-blind, placebo-controlled intervention clinical study to assess the effectiveness of biophoton therapy ...

7. biomedres.us biomedres.us/fulltexts/BJSTR.MS.ID.009718.php

Biophoton Therapy Successfully Treated Multiple Gene ... This report highlights biophoton technology's potential as a safe, holistic therapeutic approach for complex degenerative and genetic conditions ...