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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Biophoton Therapy for stem cell proliferation?

Research on similar treatments, like photobiomodulation therapy using red LED light, shows it can enhance the growth and development of stem cells, which might suggest potential benefits for Biophoton Therapy in promoting stem cell proliferation. ^{1 2 3 4 5}

Is Biophoton Therapy generally safe for humans?

Studies on low-level laser therapy, a form of Biophoton Therapy, suggest it is generally safe, but effects can vary with dose. In mice, long-term use on bone marrow showed no harmful effects, and in human-like cells, lower doses were safe while higher doses could be harmful. ^{6 7 8 9 10}

How does Biophoton Therapy differ from other treatments for stem cell proliferation?

Biophoton Therapy is unique because it uses light to stimulate stem cell proliferation and differentiation without genetic manipulation or external materials, making it a non-invasive and potentially safer option compared to traditional methods that may involve chemical or genetic interventions. ^{11 12 13 14 15}

Research Team

James Z Liu, MD, PhD

Principal Investigator

First Institute of All Medicines

Eligibility Criteria

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

Must be fluent in English

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Quantifying Biophoton Emissions From Human Cells Directly Exposed to Low-Dose Gamma Radiation. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Photobiomodulation Therapy in Bone Repair Associated with Bone Morphogenetic Proteins and Guided Bone Regeneration: A Histomorphometric Study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Biophoton detection as a novel technique for cancer imaging. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Three photobiomodulation protocols in the prevention/treatment of radiotherapy-induced oral mucositis. [2021]

5. England 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of He-Ne laser (632.8 nm) and Polygen on CHO cells. [2015]

7. United States 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. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Different doses of low-level laser irradiation modulate the in vitro response of osteoblast-like cells. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Biochemical and morphological changes in Escherichia coli irradiated by coherent and non-coherent 632.8 nm light. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Red-light light-emitting diode irradiation increases the proliferation and osteogenic differentiation of rat bone marrow mesenchymal stem cells. [2018]

11. United States 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. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Photomodulation of proliferation and differentiation of stem cells by the visible and infrared light. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Low-level visible light (LLVL) irradiation promotes proliferation of mesenchymal stem cells. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Angiogenic protein synthesis after photobiomodulation therapy on SHED: a preliminary study. [2020]

15. England pubmed.ncbi.nlm.nih.gov

Lasers, stem cells, and COPD. [2021]