Study Enrollment Each potentially qualified volunteer will review the Informed Consent
Form online (e-ICF) and Enrollment Criteria online (e-Criteria) first, then discuss the
e-ICF and e-Criteria with the study team medical professional via telephone during the
scheduled time. Each qualified volunteer will sign the e-ICF and send it to the Medical
Office Coordinator. The Coordinator will assign the qualified volunteer a randomized
subject number, then the volunteer will become a study participant.
Study Procedure We expect that the participant will stay in this clinical treatment for 2
weeks, or 4 weeks if the participants are randomly placed in a placebo group. The first 2
weeks of participation are double blinded to record the placebo effects, as each set of
the study device is labelled with a unique code for use by only one participant. The
change of the placebo device to the treatment device will be performed by the study
device management team staff who will not inform the study participant nor study research
staff who involve study data collection. Each participant assigned to the Control Group
will be treated with the 4 placebo devices and placed on the 4 corners of the bed. Each
participant assigned to the Treatment Group will receive 4 Biophoton generator devices
and placed on the 4 corners of the bed. Each participant will use the Treatment or
Control device for at least 8 hours every night for the 2 weeks during sleep. During the
day, participants are welcome to bring the study devices and place them near the body
during the daytime. At the end of the initial 2 weeks, study participants randomized to
the Placebo group will be advised whether they will use the Open-Labeled product to treat
them for 2 weeks. Each participant will be guided by study team staff to perform the
following tests on their assigned testing days: a visual analog scale of pain, the
standard SF-36 questionnaires (SF-36) for measuring life quality, and stem cell
examination respectively at the Baseline, one and two weeks after using the study
devices.
Study Supply All study devices (Placebo or Treatment) will be packed for easy use. Each
participant will use the assigned devices during the 2-week study period (Treatment
Group), or for 2+2 weeks (Placebo Group) after being switched to the Treatment group
after the first two weeks of the placebo period.
Study Patient Population The adult who wants to increase stem cells without major health
issues.
Investigational Product and Mode of Administration Tesla BioHealing Biophotonizer-A 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 or inactive
Biophotonizer-A will be labeled with a code. The participant and/or caregiver 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.
Comparator and Mode of Administration Clinical measurements will be conducted by medical
professionals. The same shape, size, and weight of the device without generating
biophoton is to be labeled with a random code and used as a comparator. The comparator
device will be placed at the 4 corners of the bed during nightly sleep during the entire
study period. The participant will record the life quality changes and answer the
10-point pain scale questionnaires. Clinical measurements will be conducted by medical
professionals.
Study Duration Estimated date of the first patient enrolled: January 14, 2025. The
estimated date of the last participant completed: December 15, 2025.
Duration of Treatment Participants in the Treatment Group and Control Group will actively
participate in the study for 2 or 4 weeks. Each Participant will answer the standard
study questionnaires respectively at the baseline, at the end of each week.
If the participant wants to continually improve her/his stem cell counts after completing
the study, the active device can be continually used for four more weeks with a small
rental fee. Then, all study devices will be shipped back to the study center.
Outcome Variables
Primary Outcome Measure:
Stem cell counts. [Time Frame: baseline, 0-2, 0-4 weeks].
Secondary Outcome Measure:
Life Quality. Short Form Health Survey (SF-36) [Time Frame: baseline, 0-1, 0-2, 0-3,
0-4, is to measure the quality of life as influenced by the investigational medical
device. SF-36 has been used worldwide as a standard clinical research tool.
Pain Disability Index (PDI) [Time Frame: baseline, 0-1, 0-2, 0-3, 0-4]. The PDI
measures the degree to which pain impacts 7 different categories of daily
activities.
Pain medicine use. The reported pain medicine use will be tabulated and analyzed.
[Time Frame: baseline, 0-1, 0-2, 0-3, 0-4].
Safety Outcome: Occurrence of adverse events. Any adverse events were reported by
participants. [Time Frame: Any Adverse Events occurred at the baseline, and up to 4
weeks.] Any adverse events reported by participants will be tabulated and compared
between the two groups.
Eligibility Criteria
Inclusion Criteria:
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.
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
Had been treated with Stem Cell therapy within a 6-month period.
Statistical Methods The sample size is calculated based on the primary efficacy variable
and the data from the pilot study in self-grown stem cells (more than 70% success, for
the treatment, and less than 10% success for the not treated) to compare the treatment
with Biophoton Generator, which was at least 70% successful and to compare with placebo.
We plan to enroll 23 Participants in each group to have 19 completers by adding 4 (20%)
more participants. Therefore, a total of 46 participants will be enrolled. If the
Principal Investigator decides to increase the enrolment to enable statistical difference
between the two groups, the enrollment can be continual. Primary and secondary outcome
variables will be statistically analyzed by using Chi-square analysis or paired T-Test.