Consent for Stemplate™ Procedure

The purpose of this document is to inform you about the StemPlate™ Procedure offered by Human Regenerative Institute, Inc. ("HRI"), including the risks and possible benefits of the procedure, and to obtain your informed consent prior to proceeding forward. By signing below you will be certifying that you understand the contents of this document, HRI's StemPlate™ Procedure, and that you have had the opportunity to review it with a physician or medical professional of your choosing, so please read this carefully and ask any questions you may have while it is being reviewed with you.

I. General Overview

HRI's StemPlate™ Procedure has two distinct, but functionally related components: (1) HRI's Stem Cell Procedure and (2) HRI's PRP Procedure. By combining both procedures, HRI believes that you will achieve the maximum assisted regenerative effect. HRI's Stem Cell Procedure has three basic steps. First, fat tissue is extracted from your body through a process commonly known as liposuction. Second, your stem cells are separated from fat tissue at HRI's on-site lab. Third, your stem cells are injected into a pain affected or injured area of your body. These three steps take place in a single procedure at HRI's facility. It is HRI's belief that placing stem cells in an injured or otherwise affected area will promote cellular regeneration and healing. This belief is based on scientific research, reports, and publications of scientific and public media origin, but not yet on FDA or other governmental agency approval.

HRI's PRP Procedure uses Platelet Rich Plasma ("PRP") to enhance pain mitigation and other regenerative capacities. PRP is a less invasive procedure and it is sometimes used as a stand alone process. In basic terms, blood is drawn, centrifuged to concentrate platelet count, and then injected into an affected area. As with its Stem Cell Procedure, HRI believes that PRP promotes healing and aid the body's own regenerative capacities.

After laboratory work, a physician will use ultrasound guidance to inject stromal stem cells and the PRP into your affected area. HRI will then schedule a check-up appointment with a physician to monitor your progress and recovery. This follow-up will also include an MRI to help monitor recovery. It is important for you to understand that depending on the nature and severity of your injury or condition, you may need more than one stem cell injection as part of this procedure. If possible, and if you give separate consent, HRI will cryogenically freeze excess stromal cells for implant at a later date as part of your StemPlate™ Procedure.

It is also possible that over time that you may need another procedure. Whether a StemPlate™ Procedure or a PRP Procedure is desired depends on many factors, the most important being the nature of your injury and the regenerative capacity of your own body. It is impossible for HRI to predict whether you would need another StemPlate™ Procedure, or any components thereof, but you must understand that it is possible given individual injuries and recoveries. You, your body, and your primary physician will guide any such future decision in this regard.

If you have any questions or concerns about participating in HRI's StemPlate™ Procedure or any of the information in this Consent Form, you should consult with a medical doctor or other healthcare professional of your choosing. This is an experimental procedure and no matter what you may have heard or read, the risks and benefits of using given type of stem cells and PRP are unknown. You should also be aware that HRI's StemPlate™ Procedure is not approved by any medical board or agency in Illinois or by the Federal Government.

II. What Are Stem Cells?

Stem Cells are some of the most basic cellular structures in our body and they perform regenerative functions throughout our body to recover from injury or other trauma. HRI's Stem Cell Procedure is based on the scientific belief that stem cells may be moved from a healthy part of the body to an injured area. Once in the injured area, the stem cells will promote healing and regeneration of healthy cellular structures.

III. HRI's Stem Cell Procedure

HRI's Stem Cell Procedure is based on using autologous adipose-derived stromal cells, including adult (mesenchymal) stem cells, for pain and inflammation management upon orthopaedic conditions of different origin.
The purpose of this procedure is to obtain an extraction of your own stem cells, so-called mesenchymal stem cells ("MSCs"), along with other stromal cells originated from your fat tissues. Fat tissue is known as a rich source of MSCs. The characteristics and differentiation capability of these cells after being placed into different kinds of human tissue have been demonstrated as well. Importantly, collection of your own stem cells will assure immune compatibility with your body when transferred back to you.

After removal of your fat tissue through liposuction, HRI's on-site laboratory will separate fat cells from the regenerative stromal cells. The stromal cells will then be prepared in the laboratory for injection back into your body. Although stromal cells can be multiplied, HRI does not employ any process to culture, multiply, or do anything more than "minimal manipulation" (separating stromal cells from fat cells) due to regulatory restrictions. The stromal cells will then be injected into the affected part of your body by a licensed physician using an ultrasound.

Importantly, none of these steps change the biological characteristics of the extracted cells. HRI's Stem Cell Procedure focuses on the extraction and concentration of healthy stem cells and re-injection into an affected area to promote regenerative healing.

IV. HRI's PRP Procedure

Platelet Rich Plasma (PRP) is an emerging biologic tool in orthopedic surgery and regenerative medicine. HRI believes that PRP has advantages over other potential therapies in that it is autologous and obtained from client's own blood. In general, PRP can be defined as plasma with enriched levels of platelets relative to whole blood. Platelets contain powerful biological factors, supporting regeneration and healing process. As the concentration of platelets rises, the amount of these healing factors increases. Scientific research supports PRP's viability, but, as with HRI's Stem Cell Procedure, it is experimental and neither risks nor benefits have been conclusively established. HRI believes that using the PRP process will provide a further regenerative quality to its Stem Cell Procedure to maximize a sustainable outcome for our clients and potentially will decrease the need for additional procedures, again depending on the severity of your injury.

For reference, in order to obtain PRP, 50-100 ml of blood will be drawn from you prior to liposuction and will be concentrated in HRI's laboratory during the time that your Stem Cell Procedure is taking place.

V. Potential Risks

Known Risks. HRI is not aware of any proven risks unique to autologous (single person) stem cell procedures, nor is it aware of any risks associated with the PRP procedure. However, any needle injection and even minimally invasive procedures like liposuction do carry health risks. These risks include, but are not limited to, pain, bruising and discomfort associated with both the liposuction procedure and re-injection of stem cells and PRP to an affected area. Liposuction also has the cosmetic "risk" of leaving noticeable fat removal pockets, although these are uncommon and generally disappear within a few days or weeks after liposuction. Because the amount of fat tissue removed is modest, HRI does not anticipate any cosmetic "risk," but the liposuction physician will provide more information and a separate consent form relating to this procedure. Finally, there is always a risk when blood is drawn or when injections are made. These risks include temporary pain associated with the needle stick, a small risk of bruising, and a rare risk of infection.

Unknown Risks. Because HRI's Stem Cell Procedure —like all stem cell procedures—and its PRP Procedure are scientifically new and therefore "experimental," the risks are unknown and/or unreported because clinical testing is ongoing. Moreover, because these applications are in different stages of development, none have been approved by the Food and Drug Administration or other regulatory bodies at this time, except for certain bone marrow stem cell use for transplantation. This is a developing area of science and while multiple clinical studies are underway, it is simply too early to document what may be found as short or long term risks. You should understand that just because direct risks have not been found yet does not mean that those risks do not exist. Indeed some have theorized that moving stem cells from one part of the body to another could spread a latent disease, such as cancer. While HRI does not believe that this makes sense from a cellular or medical basis, the simple answer is that no one has proven anything one way or the other at this stage. We encourage you to conduct independent inquiry as you see fit and to consult your primary care physician with any questions you may have.

VI. Potential Benefits

Many researchers and physicians have reported very positive and beneficial results from using mesenchymal stem cells for various applications. Additionally, stem cell treatments are used in several countries other than the United States. There are currently hundreds of studies underway relating to stem cell benefits here in the U.S. as approval from regulatory agencies and documentation of efficacy in the larger medical community is sought. These studies range from using stem cells to help chronic pain to full cardiovascular regeneration studies, including those being conducted at Northwestern University's Cardiovascular Regenerative Medicine Program. While many positive results have been expressed, the experimental and "new" nature of stem cell procedures mean that the results are still being compiled and examined by the wider research and medical communities in the U.S.

In the same way, the efficacy of PRP has not been established by any medical or regulatory body. HRI believes, however, that the acceptance of PRP in the Orthapedic and regenerative community is well founded based on the logical benefits of using concentrated blood platelets for regenerative and healing processes. We encourage you to conduct independent inquiry as you see fit and to consult your primary care physician with any questions you may have.

VII. Alternatives

There are alternative treatments for any services provided by HRI. These range from physical therapy to surgery and can be invasive or non-invasive. Most or all of these alternatives have been medically accepted, can be explained to you in full detail by the physician or other health care professional of your choosing, and may be more appropriate or advantageous to you. To be clear, HRI's StemPlate™ Procedure is not being presented as a substitute or medically accepted alternative to any such procedure. It is, as has been described above, an experimental procedure that should be considered and evaluated as such by you and/or your primary or other physician.

VIII. Exclusions

• You cannot receive HRI's StemPlate™ Procedure if you are pregnant. It is strongly recommended that females do not attempt to become pregnant or that males do not father a child during the course of HRI's StemPlate™ Procedure. Please discuss necessary precautions with your physician as well concerns about future child bearing with your physician prior to beginning the StemPlate™ Procedure. Please inform your physician immediately if you suspect you have become pregnant and the treatment will be terminated.

PLEASE NOTE while HRI is not aware of any study or proffered theory of any kind that stem cell or PRP procedures carry any enhanced risk for pregnant women, because the procedures are experimental, HRI chooses to voluntarily respect the convention against performing any experimental procedures with women who are or may become pregnant.

• You also may be excluded based on prior medical history. For example, you cannot receive HRI's StemPlate™ Procedure if you have had cancer or other exclusionary factors.

IX. Use of Data and Confidentiality

Your participation as an HRI StemPlate™ Procedure client will be noted in your medical records. Your records may be accessed by authorized representatives of your doctor's office to check medical information collected from you, provided you give such authorization. The confidentiality of your medical records will be strictly maintained and accessed only to the extent permitted or required by applicable law.

It is also contemplated that HRI may participate in a clinical research study relating to the use and effectiveness of its StemPlate™ Procedure, Stem Cell Procedure and/or PRP Procedure. By initialing below, you are agreeing to allow HRI to use data gathered from you as part of a study or its qualification to conduct such a study. While the results of such a clinical evaluation may be published, no information identifying you or your participation in HRI's StemPlate™ Procedure, Stem Cell Procedure or PRP Procedure will be used other than through a generic "Client X" form of description.

Agreeing to HRI's use of your data is optional. Your decision to opt out of this confidential data collection will not affect your eligibility to use HRI's StemPlate™ Procedure.

X. Insurance

HRI's StemPlate™ Procedure is experimental and not covered by most, if any, insurance plans. If you have any questions about insurance coverage, you should consult with your insurance company. HRI makes no promises or representations of any kind regarding insurance coverage.