Methods, Patient Background and Results
The observations compiled by licensed physicians/doctors and specialists in the medical field were entered and compared. It was observed that using ImunStem product provokes a significant response, i.e., a reduction in symptoms for patients with Serious or Life-threatening conditions or diseases that required monitoring for doses and reactions by both the attending licensed physician/doctor, registered nurse, or another specialist in the medical field. Evidence-Based Medicine is a set of principles and methods intended to ensure that to the greatest extent possible, clinical judgment or medical decisions are made.
Patient with Intermittent Explosive Disorder and Attention Deficit Hyperactivity Disorder
J.W. is a 10-year-old white male who began treatment with physician psychiatrist in Visalia California when he was 6 years old. He has been diagnosed the fragile-X syndrome. He was diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) (F90.1), and Intermittent Explosive Disorder (IED) (F63.81). He has been treated over the years with Tegretol, Vyvanse, Zoloft, and Risperdal; he had a trial at another medical center of R Baclofen. Psychiatrists have also treated him with Gabitril, and Nudexta. He was taking Zoloft 150 mg in the morning, Risperdal 1 mg at bedtime, and Vyvanse 40mg in the morning. Results: On July 07, 2016 he started ImunStem twenty drops twice a day. On July 25, 2016, his mother reported as of this date that he was more focused and calmer. His level of perseveration has decreased dramatically. His mother stated that the other day he was organizing the DVD player in their home and “that’s not like him.”
Patient with Attention Deficit Hyperactivity Disorder
S.W. is a 64-year-old white male who began treatment with psychiatrist when he was 57 years old. He was initially diagnosed with anxiety disorder Not Otherwise Specified (F41.9) and ADHD without hyperactivity (F90.0). Stimulant medication was not effective in treating his focusing problems so Wellbutrin was used. Clorazepate was used to help with his anxiety. He did well with this combination of medicines until November 2014. He was diagnosed then as having diabetic neuropathy and was treated with Lyrica. He complained then that the medicine made him feel “fuzzy” and he could not be productive at work. In February 2015 he stopped the Clorazepate because he was afraid of having Alzheimer’s disease and decreased the Wellbutrin on his own to decrease the fuzziness. He restarted the Clorazepate, eventually. In April 2016 he was taking Cymbalta 60 mg in the morning and Ambien 10 mg at bedtime. His family doctor had ceased the Wellbutrin and Chlorazepate. He was being treated at that point in time with methadone and Lyrica. He complained again of feeling fuzzy, tired, and unable to do his work. Results: In July 2016 he was started with ImunStem twenty drops twice a day. He reported two and a half weeks later that he had more energy and motivation. He was more productive and able to do his work and his pain had been reduced by thirty percent.
Patient with Schizoaffective Disorder and Polysubstance Abuse
S.R. is a 39-year-old white male who was first seen when he was 28 years old. He was transferred from another physician and was taking Wellbutrin-SR 100 mg three times a day, Clozaril 600 mg at bedtime, Zoloft 200 mg in the morning, Topamax 100 mg at bedtime, and Aricept 20 mg at bedtime. He had a significant history of substance abuse, including marijuana, crack cocaine, mushrooms, and acid between the ages of 17 & 21 years old. He was diagnosed with schizoaffective disorder (F25.9) and Polysubstance abuse. He was treated with multiple medications over the years to try to help reduce his psychotic symptoms and increase his sociability. In June 2016 he was taking Vraylar 6mg in the morning, Fanapt 6 mg twice a day, Nudexta 20 - 10 twice a day, Chlorazepate 30 mg at bedtime, Prozac 40 mg in the morning, Clozaril 300mg at bedtime, Abilify 30 mg in the morning, and Gabitril 4 mg at bedtime. Results: On July 07, 2016, he was started with ImunStem twenty drops twice a day. He returned on July 21, 2016, reporting that he had decreased the Clorazepate to 15 mg at bedtime, his Prozac had been increased to 60 mg in the morning and he had been on ImunStem for two weeks as well as the other medications listed above. He reported, “My brain can keep up with my mind”. He stated, “My brain is aware of my body”. He reported increased energy, clearer thoughts, and non-racing thoughts. He also reported that he had a dry patch of skin on the back of his head that was now gone.
Patient with Alzheimer’s Disease
L.H. is an 86-year-old white female who was diagnosed as having Alzheimer’s disease and lives in a skilled nursing facility. She was on a liquid diet, sleeps most of the time, was confined to a wheelchair or a moving bed, and had intermittent episodes of agitation and flat facies. She has been treated with ImunStem ten drops twice a day for two and half weeks. Both staff and family report that she is less agitated, more alert, and smiling. Results: After thirty days on ImunStem the nurses report there are no longer any agitated episodes and she spends more time awake. On exam, the patient opened her eyes and focused on my face. There was no facial expression, but the patient appeared to try and move her lips as if she wanted to talk. (This was a new behavior). When I asked her to move her finger if she could understand me, she did.
Patient with Lymphocytic Leukemia
M.B. is a 69-year-old white male who has been treated for chronic Lymphocytic Leukemia for the last five years. He started taking ImunStem twenty drops twice a day in October of 2015. This was because of the concern about falling red blood cell counts and platelet counts. His white blood cell count, though elevated remained elevated, and fluctuant. Results: In October 2015, his red blood cell was four point zero five (4.05) and his platelet count was ninety (90). In April 2016 his red blood cell count was four point nineteen (4.19) and his platelet count was one hundred and five (105). It was felt that this was a significant increase in both his red blood cell count and platelet count. Please see Table 1 as follows:
Patient with Substance Abuse
R.B. is a 62-year-old white male who was first evaluated on August 19, 2016. He is taking Actos, Metformin, Lorstan, and Travastin for diabetes mellitus, high blood pressure, and glaucoma. There is no history of past substance abuse. He was interested in trying ImunStemto see if it would make any difference to his medical problems. He also complains of mild symptoms of depression including anergia, lack of motivation and feeling depressed about his physical problems. He was diagnosed with depressive disorder Not Otherwise Specified and started on ImunStem twenty drops twice a day. Results: The patient reported after eight weeks of ImunStem treatment that his energy and motivation have increased. He also reported that he was feeling less depressed. He reported that he was able to tolerate higher loads of carbohydrates without changing his diabetes medications, which also affect directly his energy and motivation.
Patient with Colon Cancer
J.O. is a 45-year-old white male diagnosed with advanced stage four colon cancer. He was diagnosed in January of 2016 and was not thought by the attending physician that he could have a positive outcome as the cancer was in mastitis and had spread throughout his body. His symptoms included a damaged liver, renal obstruction, lung polyps, anxiety, depression, and severe lack of energy. The patient received the first cycle of chemotherapy in March 2016. Results: In April 2016 the patient received his first dose of ImunStem administered orally at forty drops three times daily. At this time the patient showed noticeable improvement in overall health in minutes. The patient showed an improvement in energy levels as the next day he was playing basketball, mental focus, depression, and anxiety improved noticeably and his outlook on life was a positive hope. His tumors have shrunk and since the treatments of ImunStem and chemotherapy he has had no major side effects such as hair loss, debilitating constipation, depression, anxiety, weight loss, or nausea. He has not had to visit the emergency for complications except for a staph infection at his injection port. The patient is doing well and can function without interference with his normal lifestyle. The patient has been motivated to tell others of the benefits of taking ImunStem that it can help others with Serious or Life-threatening conditions or diseases (Table 2).
Patient with Autism/Seizure
J.A. is a 2.5-year-old male that was diagnosed with Autism/Seizure. His symptoms included: seizures, drooling, hyperactivity, disorientation, lack of pain stimuli, poor communication skills, and uncontrollable outbursts. He was diagnosed in October 2016 and was considered near the highest level of autism that provided government programs to assist with his mental state. He has an unknown regimen of prescription medications, and government assistance is provided for the re-education of motor skills. Results: In December 2016 he began oral administration of ImunStem at two drops per 12 fluid ounces of milk. In approximately four days his parents noticed he was aware of his surroundings and responded to the parents’ directions. He was also noticed to cease drooling and felt pain in normal situations (such as falling while playing). He also had a reduction in seizures. He improved where no known seizures are being observed and he is more responsive to direction, his drooling has not returned and he is acting like a normal 2.5 years old.
Patient with Advanced-Stage Parkinson’s Disease
S.R. is a 62-year-old black male that was diagnosed with advanced-stage Parkinson’s disease. He was diagnosed 4 years ago and has had a steady progression of Parkinson’s disease. The symptoms include, slurred speech, an unsteady (uneven) gait, memory loss, depression, tremors and occasional falling. He has taken the prescribed medication, which had only intermittent results. Results: In April of 2015 he began taking ImunStem oral administration at thirty drops twice a day. He states he feels more stable as he can walk on his own, has no more falling episodes, can focus better (clearer thought), has reduced tremors and has significantly reduced his depression. He has also returned to his previous employment.
Patient with Excessive Menstrual Bleeding and Painful Menstrual Periods
R.W. is a 16-year-old female that has had excessive menstrual bleeding and long painful menstrual periods since Year-2013. She took Vicodin every month on the first day of her period. She had a debilitating pain that interfered with her lifestyle and activities and kept her confined to her home. Results: In October of 2016 she began taking ImunStem oral administration at thirty drops per day. After three weeks, her menstrual bleeding reduced and her pain had been alleviated. Her period duration had dropped by half and she could function in public as normal.
Patient with an Enlarged Prostate
R.G. is a 60-year-old male diagnosed with an enlarged prostate. He had been to multiple medical professionals that have treated him for everything from bleeding eyes to a heart attack. Physicians have recommended various surgeries for his prostate but the patient did not want to have these surgeries because of the possible adverse outcomes. Results: In October 2017 he was administered ImunStem while in the hospital being treated, within three minutes he felt an improved feeling in his prostate which felt like less pressure and less pain. He continued to improve over four months and no longer requires invasive procedures to alleviate prostate swelling. Please see the Table 3 as follows:
Patient with Multiple Sclerosis (MS)
E.B. is a 46-year-old white male diagnosed with Multiple Sclerosis (MS) in November 2016. He was the first suspect as having Lyme disease but upon further testing it was found to be MS. He experienced a continual degradation of motor function until he was bedridden, and he had almost total immobility of his legs and arms. The caregiver would assist the patient with all movement including bathroom activities. Results: The patient began taking ImunStem in October 2017 and showed a positive response for the first dose. Throughout treatments, the patient has experienced improved motor function to where he can sit in a wheelchair and move and can sit on the toilet without the aid of the caregiver. The patient continues to show marked improvement as the treatment progresses. The see Table 4 is as follows.
Patient with Esophageal Cancer
R.H. is a 54-year-old white male who was diagnosed on December 26, 2016, with esophageal cancer in stage two after the patient collapsed for no apparent reason and began spewing blood. The patient was rushed to the local emergency room where testing immediately began and the diagnosis was made. The patient refused standard medical cancer treatment (chemotherapies). Results: The patient began taking ImunStem on February 20, 2017, and showed improvements in both reports blood reports and medical scans. The physician at the hospital after reviewing the blood report and medical scans recommended: “resume regular diet” and receive another checkup in four weeks. Please see the Table 5 as follows:
**NOTE: Administration of ImunStem products should always be under the supervision of a licensed medical practitioner, or a physician/doctor. Recommendations for ImunStem products are based on the following criteria: medical evaluation/assessment, diagnoses, monitoring, and medical report results of the patient, for treatment of Serious or Life-threatening conditions or diseases. Evidence-Based Medicine is a set of principles and methods intended to ensure that to the greatest extent possible and clinical judgment or medical decision are made.
Results and Discussion
To sell any new drug/medicine in the United State of America, Golden Sunrise Nutraceutical, Inc. (Golden Sunrise) must comply with the FDA under 21U.S.C. §355(a). ImunStem product with an NDA No.: 204701 must contain complete medical report results and an Investigator’s Brochure about the drug/medicine, including safety, effectiveness, the composition of the drug/medicine, description of how the drug is manufactured, and proposed labeling under 21U.S.C. §355(b).
On July 02, 2018, ImunStem received from FDA, NDC Directory No.: 70642-001-01 Human Prescription Drug. The FDA agreed to Priority Review designation for ImunStem product with the notification of the New Drug Application on January 07, 2013.
A small group of patients with serious or life-threatening conditions or diseases found that ImunStem dietary supplement improved the immune system and alertness immediately. Physicians/doctors have observed that using ImunStem provokes a significant response, i.e., a reduction in symptoms in patients with these diseases; autism, Alzheimer’s, neuropathy, chronic lymphocytic leukemia, multiple sclerosis, Parkinson’s, schizoaffective disorder, fragile-X syndrome, and a significant decrease of side-effects to chemotherapy for cancer.
ImunStem has been shown to help reduce the loss of blood from the surgical wound and menstrual periods (shorter and lighter periods). Over hundreds of Serious or Life-threatening conditions or diseases, patients’ test subjects administered ImunStem dietary supplement over time, from a few weeks up to five years, were made and included in observations from attending physicians, nursing staff, caregivers, and Golden Sunrise medical personnel. Blood reports were also included and medications (if any) were documented. The observations compiled from family physicians/doctors and specialists were entered and compared with observations by Golden Sunrise medical staff. Safety was monitored and throughout these studies no adverse side effects were noticed. A representative number of test subjects were diagnosed with Serious or Life-threatening conditions.
The FDA gave Golden Sunrise the FDA Expedited programs for regenerative medicine therapies for serious illnesses. Fast track is a process designed to facilitate the development. In 1992, the FDA instituted the Accelerated Approval regulations. These regulations allowed drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint. Using a surrogate endpoint enabled the FDA to approve these drugs faster. Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review). Under the 21st Century Cures Act patients suffering from Serious or Life-threatening conditions or diseases were treated and were required to have close monitoring by the attending doctor or medical professional of that field and by Golden Sunrise medical staff.
The administration of ImunStem to patients suffering from Serious or Life-threatening conditions or diseases has shown improved outcomes as observed by physicians/doctors. Patients have experienced a better quality of life and an extended timeframe to live an active lifestyle (for example, end-stage cancer patients being able to travel). ImunStem treatment to patients has generally shown a reduction or elimination of pain caused by an ongoing illness. This benefit has positive effects on the patient reducing stress and anxiety to help the healing process.
Tieu, H. and Loeffler, M. (2022) FDA Approves First Dietary Supplement under New Drug Application with the Indication of Serious or Life-Threatening Illnesses. Pharmacology & Pharmacy, 13, 529-544. doi: 10.4236/pp.2022.1312038.