Biophoton Therapy for Stem Cell Proliferation (Stem Cells Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: First Institute of All Medicines
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.
12345Is 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.
678910How 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.
1112131415Eligibility 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.Exclusion Criteria
I have received stem cell therapy in the last 6 months.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 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 ControlPlacebo Group1 Intervention
Each participant assigned to the Control Group will be treated with the 4 placebo devices
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Tesla MedBed at Tampa-FLTampa, FL
Tesla BioHealing Wellness Hotel - Butler-PAButler, PA
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Who is running the clinical trial?
First Institute of All MedicinesLead Sponsor
References
Quantifying Biophoton Emissions From Human Cells Directly Exposed to Low-Dose Gamma Radiation. [2020]Biophoton emission leading to bystander effects (BEs) was shown in beta-irradiated cells; however, technical challenges precluded the analysis of the biophoton role in gamma-induced BEs. The present work was to design an experimental approach to determine if, what type, and how many biophotons could be produced in gamma-irradiated cells. Photon emission was measured in HCT116 p53+/+ cells irradiated with a total dose of 22 mGy from a cesium-137 source at a dose rate of 45 mGy/min. A single-photon detection unit was used and shielded with lead to reduce counts from stray gammas reaching the detector. Higher quantities of photon emissions were observed when the cells in a tissue culture vessel were present and being irradiated compared to a cell-free vessel. Photon emissions were captured at either 340 nm (in the ultraviolet A [UVA] range) or 610 nm. At the same cell density, radiation exposure time, and radiation dose, HCT116 p53+/+ cells emitted 2.5 times more UVA biophotons than 610-nm biophotons. For the first time, gamma radiation was shown to induce biophoton emissions from biological cells. As cellular emissions of UVA biophotons following beta radiation lead to BEs, the involvement of cellular emissions of the same type of UVA biophotons in gamma radiation-induced BEs is highly likely.
Photobiomodulation Therapy in Bone Repair Associated with Bone Morphogenetic Proteins and Guided Bone Regeneration: A Histomorphometric Study. [2019]To evaluate the efficacy of photobiomodulation for bone repair of critical surgical wounds with implants of bone morphogenetic proteins (BMPs) and bovine biological membranes, using histological and histomorphometric analysis.
Biophoton detection as a novel technique for cancer imaging. [2019]Biophoton emission is defined as extremely weak light that is radiated from any living system due to its metabolic activities, without excitation or enhancement. We measured biophoton images of tumors transplanted in mice with a highly sensitive and ultra-low noise CCD camera system. Cell lines employed for this study were AH109A, TE4 and TE9. Biophoton images of each tumor were measured 1 week after carcinoma cell transplantation to estimate the tumor size at week 1 and the biophoton intensity. Some were also measured at 2 and 3 weeks to compare the biophoton distribution with histological findings. We achieved sequential biophoton imaging during tumor growth for the first time. Comparison of microscopic findings and biophoton intensity suggested that the intensity of biophoton emission reflects the viability of the tumor tissue. The size at week 1 differed between cell lines, and the biophoton intensity of the tumor was correlated with the tumor size at week 1 (correlation coefficient 0.73). This non-invasive and simple technique has the potential to be used as an optical biopsy to detect tumor viability.
Three photobiomodulation protocols in the prevention/treatment of radiotherapy-induced oral mucositis. [2021]To compare three Photobiomodulation protocols to prevent/treat oral mucositis associated to radiotherapy.
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]Photobiomodulation therapy (PBMT) using a light-emitting diode (LED) has been employed for various photomedicine studies. The aim of this study was to determine the effects of a high-intensity red LED on the proliferation and osteogenic differentiation of human bone marrow mesenchymal stem cells (BMSCs) and the related mechanism. BMSCs were subjected to high-intensity red LED (LZ1-00R205 Deep Red LED) irradiations for 0 to 40 s with energy densities ranging from 0 to 8 J/cm2. The distance from the LED to the cell layer was 40 mm. The spot size on the target was 4 cm2. Cell proliferation was measured at 3, 24, 48, and 72 h. The effects of LED irradiation on osteogenic differentiation and mineralization were examined with a particular focus on the Wnt/β-catenin signaling pathway. The high-intensity red LED irradiations did not alter BMSC proliferation after 72 h. LED exposure of 6 J/cm2 (30 s) led to significant enhancements of osteogenic differentiation and mineralization. Additionally, the high-intensity LED irradiation induced activation of Wnt/β-catenin. The effects of the high-intensity LED irradiation on BMSC osteogenic differentiation and mineralization were suppressed by treatment with the Wnt/β-catenin inhibitor XAV939. P < 0.05 was considered significant. The results indicate that high-intensity red LED irradiation increases BMSC osteogenic differentiation and mineralization via Wnt/β-catenin activation. Therefore, short duration irradiation with a portable high-intensity LED may be used as a potential approach in hard tissue regeneration therapy.
Effect of He-Ne laser (632.8 nm) and Polygen on CHO cells. [2015]We determined the effect of He-Ne laser biostimulation in combination with Polygen (PG) on Chinese hamster ovary (CHO) cells.
Long-term safety of low-level laser therapy at different power densities and single or multiple applications to the bone marrow in mice. [2018]The purpose of this study was to determine the long-term safety effect of low-level laser therapy (LLLT) to the bone marrow (BM) in mice.
Different doses of low-level laser irradiation modulate the in vitro response of osteoblast-like cells. [2019]Because osteoblasts play a key role in bone remodeling and the influence of low-level laser therapy on this process is not clear, Saos-2 human osteoblast-like cells were irradiated by a gallium-aluminum-arsenide diode laser (915 nm) for 10, 48, 96, 193, and 482 s using doses 1, 5, 10, 20, and 50 J/cm2, respectively. A control group was not irradiated. Morphology, viability, and cytotoxicity analyses were carried out after 1 hr, 1 day, and 3 days. Deoxyribose nucleic acid (DNA) content and release of vascular endothelial growth factor (VEGF), receptor activator of nuclear factor kappa B ligand (RANKL), and osteoprotegerin (OPG) were evaluated. Viability was modulated by laser irradiation in a dose-dependent manner, with 10 J/cm2 inducing a biostimulatory response and 20 to 50 J/cm2 determining a bioinhibitory and cytotoxic effect. Accordingly, DNA content was generally increased for the 10 J/cm2 dose and decreased for the 50 J/cm2 dose. A rapid and transitory trend toward increased RANKL/OPG ratio and a tendency toward a delayed increase in VEGF release for doses of 1 to 10 J/cm2 was found. Further investigations using the biostimulatory dose of 10 J/cm2 emerged from this study are needed to establish the ideal treatment regimens in the laboratory as well as in clinical practice.
Biochemical and morphological changes in Escherichia coli irradiated by coherent and non-coherent 632.8 nm light. [2019]Irradiation of Escherichia coli cells with either coherent or non-coherent 632.8 nm light (4 J cm-2) causes a transient acceleration of cell proliferation, which is maximal about 60 min after the end of the phototreatment. The stimulatory effect is dose dependent and is especially evident in the case of defective E. coli strains which are in the logarithmic phase of growth, while it becomes less important when cells are exposed to non-coherent 600-700 nm light. Stimulated cells exhibit biochemical and morphological changes, such as an intensified synthesis of cytoplasmic membrane proteins, increased cell volume and ribosomal content, which are suggestive of an enhanced cell metabolism.
Red-light light-emitting diode irradiation increases the proliferation and osteogenic differentiation of rat bone marrow mesenchymal stem cells. [2018]The objective of this study was to investigate the effects on the proliferation and osteogenic differentiation of rat mesenchymal stem cells (MSCs) by using red-light light-emitting diode (LED) irradiation.
Stem cell differentiation with consistent lineage commitment induced by a flash of ultrafast-laser activation in vitro and in vivo. [2022]Recent technological advancements on stem cell differentiation induction have been making great progress in stem cell research, regenerative medicine, and therapeutic applications. However, the risk of off-target differentiation limits the wide application of stem cell therapy strategies. Here, we report a non-invasive all-optical strategy to induce stem cell differentiation in vitro and in vivo that activates individual target stem cells in situ by delivering a transient 100-ms irradiation of a tightly focused femtosecond laser to a submicron cytoplasmic region of primary adipose-derived stem cells (ADSCs). The ADSCs differentiate to osteoblasts with stable lineage commitment that cannot further transdifferentiate because of simultaneous initiation of multiple signaling pathways through specific Ca2+ kinetic patterns. This method can work in vivo to direct mouse cerebellar granule neuron progenitors to granule neurons in intact mouse cerebellums through the skull. Hence, this optical method without any genetic manipulations or exogenous biomaterials holds promising potential in biomedical research and cell-based therapies.
Photomodulation of proliferation and differentiation of stem cells by the visible and infrared light. [2018]The aim of this article is to review experimental studies of visible and infrared light irradiation of human and animal stem cells (SCs) in vitro and in vivo to assess photobiomodulation effects on their proliferation and differentiation.
Low-level visible light (LLVL) irradiation promotes proliferation of mesenchymal stem cells. [2021]Low-level visible light irradiation was found to stimulate proliferation potential of various types of cells in vitro. Stem cells in general are of significance for implantation in regenerative medicine. The aim of the present study was to investigate the effect of low-level light irradiation on the proliferation of mesenchymal stem cells (MSCs). MSCs were isolated from the bone marrow, and light irradiation was applied at energy densities of 2.4, 4.8, and 7.2 J/cm(2). Illumination of the MSCs resulted in almost twofold increase in cell number as compared to controls. Elevated reactive oxygen species and nitric oxide production was also observed in MSCs cultures following illumination with broadband visible light. The present study clearly demonstrates the ability of broadband visible light illumination to promote proliferation of MSCs in vitro. These results may have an important impact on wound healing.
Angiogenic protein synthesis after photobiomodulation therapy on SHED: a preliminary study. [2020]This study evaluated the viability, proliferation, and protein expression after photobiomodulation (PBM) of stem cell from human exfoliated deciduous teeth (SHED). The groups were the following: G1 (2.5 J/cm2), G2 (3.7 J/cm2), and control (not irradiated). According to the groups, cells were irradiated with InGaAlP diode laser at 660 nm wavelength, continuous mode, and single time application. After 6 h, 12 h, and 24 h from irradiation, the cell viability and proliferation, and the protein expression were analyzed by MTT, crystal violet, and ELISA multiplex assay, respectively. Twenty-four hours after PBM, SHED showed better proliferation. Over time in the supernatant, all groups had an increase at the levels of VEGF-C, VEGF-A, and PLGF. In the lysate, the control and G2 exhibited a decrease of the VEGF-A, PECAM-1, and PLGF expression, while control and G3 decreased VEGF-C, VEGF-A, and PDGF expression. The dosimetries of 2.5 J/cm2 and 3.7 J/cm2 maintained viability, improved proliferation, and synthesis of the angiogenic proteins in the supernatant in the studied periods on SHED.
Lasers, stem cells, and COPD. [2021]The medical use of low level laser (LLL) irradiation has been occurring for decades, primarily in the area of tissue healing and inflammatory conditions. Despite little mechanistic knowledge, the concept of a non-invasive, non-thermal intervention that has the potential to modulate regenerative processes is worthy of attention when searching for novel methods of augmenting stem cell-based therapies. Here we discuss the use of LLL irradiation as a "photoceutical" for enhancing production of stem cell growth/chemoattractant factors, stimulation of angiogenesis, and directly augmenting proliferation of stem cells. The combination of LLL together with allogeneic and autologous stem cells, as well as post-mobilization directing of stem cells will be discussed.