Please read this form entirely. It contains information to assist you in making a decision to have a specific therapy. Initial each paragraph if you understand it. If you do not understand it, do not initial it and each paragraph will be discussed with you separately. There are risks and complications that may result from this therapy, they are rare, but do exist and you must be aware of them.
Stem cells are undifferentiated cells that have the ability to self-replicate and some may change into any specific cell type in the body. These cells can be injected directly into an area of injury or given intravenously. Stem cells have a “homing” ability to go to areas of injury due to signals released by injured cells. Once stem cells reach the target tissue they begin repair of the injury or disease by releasing growth factors and immune modulators that assist in the body’s natural repair process.
Stem cells also contain chemicals that control the immune response, either regulating an overactive immune system or stimulating a weak immune system. These immune factors may also lower inflammation.
_____ Mesenchymal stem cells (MSC) are derived from the connective tissue that surrounds other tissues and organs. They may be obtained from bone marrow, fat, or umbilical cord blood obtained at birth. These cells are “multipotent” meaning they can differentiate into only a few specific tissue types, namely bone, cartilage, tendons, ligaments, muscle and fat.
_____ We obtain MSC from Predictive Biotech, which distributes umbilical cord derived products to physicians for use in regenerative medicine therapies. The stem cells are delivered cryopreserved on dry ice and are strictly compliant with FDA standards under Current Good Manufacturing Practice (cGMP) regulations.
Umbilical cord donation is guided by the American Association of Tissue Banks (AATB) for quality, safety and ethics. The cells are sourced from the umbilical cord of healthy donor volunteers painlessly and noninvasively. Each donor is carefully screened for pathogens in order to assure the product is safe.
_____ Because stem cells that are specific to certain tissues cannot make cells found in other tissues without careful manipulation in the lab, it is uncertain if the same stem cell treatment will work for diseases affecting different tissues and organs within the body.
_____ The list of diseases for which stem cell treatments have FDA approval is short. The best-defined and most extensively used stem cell treatment is bone marrow transplantation for certain blood and immune system disorders or to rebuild the blood system after certain cancer treatments. Some bone, skin and eye injuries and diseases can be treated by grafting or implanting tissues, and the healing process relies on stem cells within this implanted tissue. These procedures are widely accepted as safe and effective by the medical community. All other applications of stem cells are yet to be proven in clinical trials and should be considered experimental.
_____ Potential/theoretical risks (i.e. risks observed in animal studies) include tumor formation, unwanted immune responses, worsening of your condition, new conditions as a result of the stem cells, stem cells differentiating into unwanted tissue or causing existing cells to change their behavior.
_____ The risk of donor-to-recipient transmission of bacterial, viral, fungal or prion pathogens may lead to life-threatening and even fatal reactions. The immune suppressing nature of MSC may allow a dormant infection already in the body to become active, e.g. a flare of herpes virus, etc.
_____ MSC have been used extensively in clinics for decades. The clinical experience with these therapies indicates that i.v. administration of MSC did not reveal major health concerns, and is generally not accompanied by tumor formation. However, limitations of the safety database (i.e. number of patients treated) and lack of long-term follow-up required to study potentially rare adverse events should be taken into account when evaluating the tumorigenic potential of MSC.
_____ The vast majority of small-sized clinical trials conducted with MSC in regenerative medicine applications have not reported major health concerns, suggesting that MSC therapies could be relatively safe.
_____ The above listed risks may occur, but there may be unforeseen risks and risks that are not included on this list. Some of these risks, if they occur, may necessitate hospitalization and/or extended outpatient therapy to permit adequate treatment.
_____ Below is list of Stem Cell Contraindications and/or Relative Contraindications, none of which apply to me:
- Exacerbated vasculitis (tx is possible after at least three months of remission)
- Acute thrombosis (tx is possible not earlier than 3–6 months after exacerbation)
- Acute hemophthalmia (tx is possible after at least three months of remission)
- Bone marrow disorders
- Significant Anemia, thrombocytopenia, neutropenia
- Chronic bacterial infections (preliminary treatment is required)
- Chronic viral infections (preliminary treatment is required)
- Malignancy or immune suppressive medications
- Significant chronic disease (lung, heart, kidney, liver, etc)
- Terminal illnesses
- Psychiatric diseases (risk of exacerbation)
- Pregnant, breastfeeding
_____ I understand that stem cell therapy may not currently be medically accepted for treating certain conditions and may not be FDA‐approved. I am aware and understand the currently “standard” medically‐indicated treatment for my condition.
_____ I understand and accept that because this procedure may be considered “medically unnecessary” or “experimental”, it may not mitigate, alleviate, or cure condition(s). The possible benefits may not be apparent immediately.
_____ I understand that medicine is not an exact science and that no guarantees are offered regarding my expected results. I am aware that it is possible that this treatment will not work for me.
_____ In addition to discussing other modes of therapy that may be used for the treatment of my condition, my provider and I have discussed and I understand the possibility of a referral to a specialist in my condition(s) if I have not already consulted with an appropriate specialist.
I have read the foregoing information, it has been explained, and I understand it. All of my questions have been answered. By executing this form, I am indicating that I have no questions whatsoever and I give my full informed consent to have stem cell therapy performed. I further agree to follow all post-treatment instructions.
Patient / Legal Guardian Signature / Date:
Medical Assistant/Nurse/Physician / Date: