our scientific partners are developing the medical solutions that will matter most to the people we serve and delivering innovative treatment and therapies that benefit patients worldwide.

How We Help the Global Research Community

Solutions for a Healthier World, Inc. applies funding to science and our global resources to bring stem cell technologies to multiple global sectors. The research we fund is focused on extending and significantly improve lives.

Our success depends on superior scientific partners and the innovation, integrity and continuous improvement in all aspects of our charitable contributions through the application of the scientific method. Our science partners and affiliated companies are prioritizing their research and development efforts in areas with the greatest scientific promise: immunology and inflammation, oncology, cardiovascular and metabolic diseases, neuroscience, traumatic brain injury (including CTE), pain management, and orthopedic ailments.

Our global funding portfolio includes major research efforts across multiple modalities — including stem cell technologies, biologics, protein biochemistry molecular biological and exosomes.

We are pleased to report our efforts have paved the way to starting the world’s first and only global clinical trial to research the effects of stem cell therapies to treat CTE. Through research funding for CTE we hope to eventually serve thousands of patients by transforming science and biotechnology into treatment protocols that have the power to restore health and save lives.

We accept donations to fund research and we always aim to fulfill our mission to find Solutions for a Healthier World.

Clinical Development Process

Clinical trials involve hundreds to many thousands of volunteer trial participants. Every trial is governed using well defined criteria developed by systematic reviews.

For patients suffering from a condition that is currently untreatable, participation in a clinical trial may provide access to potential new therapies. While participating, volunteers obtain closely controlled care in research medical facilities, in addition to helping others by defined ethical rules and standards to protect participant safety.

Clinical trials mark the first time an experimental therapy is administered to humans.

Phase 1 trials usually focus on ensuring the therapy is safe to use in people, rather than how effective it may be as a treatment for a given disease. During this phase, escalating doses of the experimental therapy are given to a small number of study participants so that researchers can measure the body’s response, including how it is absorbed, its duration in the blood stream and which dosage levels are safe and well tolerated

Phase 2 trials generally assess the effectiveness of an experimental therapy at treating a specific illness or medical condition. Information about the experimental therapy’s safety, side effects and potential risks are also collected. In this phase, researchers work to determine the most effective dosages for the experimental therapy and the most appropriate method of delivery, such as tablets, extended release capsules, infusions or injections. Phase 2 clinical trials involve a larger number of trial participants, typically up to several hundred, who usually have the medical condition that the experimental therapy is intended to treat.

Phase 3 trials test the results of earlier trials in much larger groups of people and gather additional information on the effectiveness and safety of the experimental therapy. This phase will usually involve several hundred to several thousand participants across multiple study locations. These trials are often randomized, where participants are arbitrarily allocated to receive the experimental therapy, placebo or another therapy (a “comparator”), and “double-blinded,” in which neither the investigator nor the participant are aware if the therapy given is the true experimental therapy, placebo (medication with no active ingredients) or another therapy (a “comparator”). Phase 3 trials generally provide the primary basis for the benefit-risk assessment for the new therapy and much of the core information about the therapy that is analyzed for inclusion in final labeling, if approved by the regulatory authority.

Phase 4 trials — also called “post-marketing studies” — are conducted after regulatory approval and are critical to informing the ongoing use of the therapy. Through such trials, researchers collect additional information about longer-term risks, benefits and optimal use. These trials often involve thousands of participants and may continue for many years.

Who Regulates Stem Cell Treatment Protocols and Therapy?

There are two aspects to consider regarding the use of stem cell therapies in the U.S. and potential host countries outside of the U.S.

The first is the existing legal structure surrounding research, and the second is the regulatory framework regarding application of that research to treat patients.

Our donations are only granted to scientific organizations that adhere to the ethical guidelines in the host country like the guidelines promulgated by the U.S. Food and Drug Administration (FDA) under the U.S. Department of Health and Human Services, Code of Federal Regulation, Part 1271 entitled “Regulation of Human Cells, Tissues, and Cellular and Tissue Based Products”.

Regarding patient application in our host countries, prohibitions are generally in place regulating the use of embryonic stem cell. We do not fund research or fund treatment for patients with embryonic stem cells.

Clinical Trial Participation

We fund research for scientific teams that create policies and case studies to ensure and demonstrate its ethical development of new protocols or medicines. Indeed, all the funding for clinical research must be reviewed by a qualified Independent Ethics Committee or Institutional Review Boards.

Solutions for a Healthier World Foundation, Inc. does not participate in clinical research and shall not be responsible for the outcomes or reporting of clinical trial outcomes.

We request that the scientific originations report patient findings based on:

Disease and length of time after transplant: 1 year, 3 year.

Type of donor who provided the cells for transplant:
1. Autologous (the patient’s cells)
2. Related allogeneic (a patient’s sibling or another family member’s cells)
3. Unrelated allogeneic (a volunteer donor’s cells)

The cells used for transplant can be from bone marrow, peripheral blood, umbilical cord blood or adipose tissues. Outcome data shows survival information for transplant patients with a similar disease. The information cannot predict the outcome of any one person. One person’s response to transplant may be very different than another person’s response. The number of patients evaluated can greatly affect the long-term survival estimate.

When only a small number of patients are observed, the estimated outcomes can vary widely.

When a large number of patients are observed, the estimate is more reliable. Long-term survival outcomes only provide a partial picture. A patient’s specific medical condition, health, and previous treatments and other factors must also be considered. Patients should refer questions to their doctor, transplant center staff or another health care professional.

 

Notice

Solutions for a Healthier World Foundation, Inc. is not a medical provider anywhere in the world and does not perform any medical consultations, procedures, research nor does it offer medical advice of any kind. The information provided on this page is for general information only. It is not intended to provide medical advice or guidance and should not be used for that purpose. Medical use of any product or service should be strictly in accordance with the approved prescribing information.