REGENERATIVE

MEDICINE
MANUAL
 In this guide, we present to you the most popular and widespread thera-
pies that are currently listed in scientific publications, as well as those that
have demonstrated maximum efficacy and safety during their application
at the clinical level. The vast majority of these procedures and cellular
products have existed for close to two decades, but only recently have they
exploded both in popularity and availability in clinics and doctor’s offices.

Our objective is to provide doctors, healthcare workers, and other medical

professionals with information relevant to the diverse treatment options
that are available for patients around the world, as well as the instructions
and training that they would need to actually implement these cellular
therapies in their clinics.

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What is
Regenerative Medicine?
Regenerative Medicine is one of the most advanced specialties in the medical field, existing on the
bleeding edge of current scientific research and progress. It’s main focus is to incorporate treatment
protocols that enhance the body’s natural auto-healing process-- a process that occurs at the cellular
level. Whether it be through autologous or allogeneic cellular therapy, the objective of these therapies
remains the same: stimulating, enhancing, and accelerating tissue regeneration processes and the
restoration of homeostasis.

In the last ten years, contemporary scientific research has succeeded in understanding how cells
communicate, and how they both identify and respond to signals. In addition to this, we’ve also
learned how they organize into what we know as tissue to accelerate and enhance the healing
process. These advancements have permitted physicians to manipulate these processes and
implement them in a clinical and office setting.

It’s becoming increasingly common for physicians to successfully utilize these cellular therapies to
optimize the body’s processes, as well as to help regenerate muscle, bone, and cartilage tissue.
Currently, the Global Stem Cells Group has access to over five-thousand study clinics, all of which
confirm that regenerative medicine offers an above-adequate treatment option for both complex and
chronic illnesses, two places where traditional medicine has historically been unable to offer much.

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What Is
Cellular Therapy Comprised Of?
Cellular therapy encompasses a large spectrum of clinical procedures that utilize biological products--
be they freshly obtained or previously stored-- as tools of regenerative medicine to replace and or
repair cells that have been damaged as a result of the natural aging process, or even those caused by
some sort of trauma or illness.

Among the most common cellular therapies are the extremely popular exosomes, amniotic fluid,
platelet-rich plasma (PRP), and of course, the use of adult mesenchymal stem cells (MSCs). This type
of cell is found in almost all the tissues within the human body, but they have a greater concentration
in sources like umbilical cord blood, stromal vascular fraction of adipose tissue, and bone marrow.

These therapies have not only been found to be useful in the formation of tissue, but they are also
utilized in the treatment of neurological, respiratory, and metabolic conditions, in addition to being
applied to a wide spectrum of chronic and autoimmune disorders.

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What are the
Most Common
Cellular Therapies Practiced
in Clinics and Offices?
 Platelet-Rich Plasma Therapy (PRP)

PRP Therapy is a treatment that is all but standard in the medical field, for two primary reasons: its
simplicity and its effectiveness. Platelet-rich plasma is composed of elements of the blood, including
growth factors and proteins that will stimulate the number of repair cells that actually reach the site
of tissue damage.

PRP injections have already been found to treat a multitude of areas and conditions. In addition to the
already established treatments in aesthetic and anti-aging medicine, there are also applications in
traumatology, orthopedics, pain management and sports medicine. Numerous studies that have
been published confirm that the use of PRP accelerates the process of lesion-curing in the ligaments,
tendons, muscles, and joints.

Those conditions that most benefit from the utilization

of PRP treatments include:

Anti-Aging Treatments, including facial Osteoarthritis.

and wrinkle-prevention treatments.
Damage and/or lesions to the nerves.
Scars.
Conditions of the back and spinal
Alopecia. column.

Pain Management. Injuries that do not scar.

Tendonitis, or chronic lesions in the Ligaments in particular can require a

tendons. very long and painful recovery process,
and it is just this that makes PRP an
Lesions in the ligaments or muscles. attractive option for those who have
experienced lesions in the tissues of the
ligaments in this manner.

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 Plasma Gel

Plasma Gel, which can also be known as both bio-filler and ‘fibrin matrix’, is widely used within
regenerative medicine clinics for its versatility and effectiveness. It can be injected in order to treat
wrinkles and lines in the face, as well as to lift and rejuvenate areas that have suffered a loss of volume.
Additionally, this treatment achieves biostimulation through the use of stem cells and growth factors
that are known to produce collagen. Results are first visible immediately following the treatment, and
then the effects of collagen production can be seen after a handful of weeks. After two months, the
plasma gel is absorbed naturally and completely in the treated area.

Fibrin Matrix +
Growth factors

Protein Matrix

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 Exosome Therapy

Exosome therapy is also known as cellular therapy without cells. The regenerative properties of
exosomes, whether they derived from pure MSCs or from other sources including umbilical cord
blood and amniotic fluid, are due in part to the paracrine effect of these extracellular compounds. Put
very simply, exosomes are small vesicles that are secreted by cells and facilitate communication
between them. Additionally, they also possess anti-inflammatory and immunomodulatory properties,
as well as regenerative pathway activation properties.

Our injectable exosome vials contain proteins, nucleic acids, and other biological molecules contained
in small vesicles less than 150 nm in diameter.

One of the most important potential advantages of the clinical use of exosomes is that, despite its
being an allogeneic or heterologous cellular product, it contains no whole cells, which eliminates the
risk of adverse reaction due to transfer of mutated or damaged DNA.

Additionally, and this is relevant for systematic applications, exosomes are extremely small (even for
something within the human body) and because of this circulate extremely easily and quickly
throughout the body, while cells on many occasions can be retained in the lungs due to their size.
Therefore, by administering exosomes, it is possible to achieve a ‘dose’ of growth factors that circulates
throughout the body to a greater extent than that obtained with the application of MSC.

The third, and final, advantage lies in something very simple-- procedure time. LIke all allogeneic
products, exosomes do not require significant surgical intervention, investment, or equipment, nor
does it require the removal of tissue in the medical office. Thus, this treatment is a fast, effective, and
largely complication-free therapeutic option for patients and medical professionals.

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Cellular Therapy with Adipose-Derived Tissue

The stromal vascular fraction of adipose tissue is another one of the more popular and well-received
regenerative medicine therapies available, especially when it comes to autologous therapies, because
it uses the patient’s own adipose (fat) tissue as a source for the cells.

These stromal vascular cells, as they are also known, represent a potentially valuable resource for a
growing number of chronic degenerative diseases, autoimmune disorders, sports injuries, and
cosmetic applications, just to name a few fields.

The final cellular product can contain a count of anywhere between 30 and 60 million heterogeneous
cells, including mesenchymal stem cells. The process to obtain this final product can be undertaken
completely within a clinical or office setting through the laboratory process of enzymatic dissociation
and density separation, which allows immediate application of MSCs to the patient in a time frame of
2-3 hours.

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Cellular Therapy with Bone Marrow Aspirate

Cellular therapy that utilizes bone marrow aspirate has been one of the most widely known and
practiced treatment options in medical offices for the past 20 years. This is demonstrated clearly by
the number of registered case studies, as well as the innumerable scientific documentation that
validates this methodology of treatment.

Within the wide range of therapeutic applications that can be found for autologous bone marrow
cells, several medical fields are present. Orthopedics, traumatology, and pain management each show
extreme promise. This is due to the fact that stem cells that have been aspirated from the posterior
iliac crest have a high potential for differentiation and the recruitment of local cells in the area in which
they are injected. In addition to this, they support bone, cartilage, and muscle formation through the
process of osteogenesis, chondrogenesis, and myogenesis.

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 Allogeneic Cellular Therapies (From Donor)

Allogeneic cellular therapy is any cell therapy in which cells come from a ‘universal donor’, which is
someone that is compatible with any person. Among the most popular options today are therapies
with allogeneic cells that are derived from umbilical cord blood and with laboratory-grown and
expanded allogeneic mesenchymal cells.

Advantages of allogeneic cellular therapy include:

It does not require the purchase of equipment for tissue processing, nor does it require an invasive
procedure, such as in the case of autologous therapies, where the product is obtained from a
bone marrow or fatty tissue aspiration of the patient.

It is not conditioned by the age of the patient, as in the case of autologous cells, which normally
have a higher degree of senescence (‘aging’). This decreases the efficacy of autologous, but not
allogeneic, procedures in patients that are over 50 years of age, which implies a lower therapeutic
capacity.

However, the main drawback of allogeneic products and their ability for patient application for many
clinics is that these products use ultra-refrigeration. This requires special, and often expensive,
equipment to ensure that the products are kept at -80°C. In addition, once these cells are thawed, they
must be immediately applied to the patient, lest they lose their viability.

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 Amniotic Fluid and Membranes

Grafts that contain products that have been derived from amniotic fluid have recently been evaluated
as a viable treatment option for several complex diseases-- the results are quite surprising, and ripples
will surely be felt throughout the entire healthcare industry.

For example, the intra-articular injections of cryopreserved allogeneic human grats have been found
to reduce pain and improve joint function in people with symptomatic knee osteoarthritis. While this
is only a rather specific discovery so far, it points to more work to be done in terms of treating
inflammation-based conditions.

What’s more, the cellular compounds that are present in amniotic fluid have an immunosuppressive
effect that blocks microglial migration and stimulates the recruitment of immune cells, attenuating
oxidative stress and improving tissue regeneration.

The amniotic membrane is the immunologically privileged inner layer of the placenta. Amniotic cells
are multipotent stem cells that exert their actions through trophic mechanisms, including the
secretion of cytokines that act as paracrines and growth factors that have immunoregulatory
properties.

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 IV Therapy

Intravenous supplementation or infusion therapy can be administered to patients either before,

during, or after a cellular therapy, and it has been found to work extremely well in conjunction with
stem cell treatments in a regenerative medicine clinic.
IV Therapy, as it is commonly known, has been found to be an effective way to deliver nutrients,
vitamins, and medications throughout the body, in order to improve its cellular function. These
supplements are administered directly to the vein, which ensures that the infused substances
circulate through the bloodstream-- this direct method of administration rapidly improves the
functioning of all cells in the body.

When the infusion is administered to a patient before their cellular therapy, it not only accelerates the
effectiveness of the treatment, but it also has the potential to influence the regenerative function of a
wide variety of bodily systems-- this is due to the fact that vitamins, amino acids, proteins and minerals
are directly assimilated into the cells that need them the most, leading to an overall increase in vitality.

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What do you need
to offer this type of
Therapy in Your Clinic
Training
When talking about everything needed to set up a well-functioning regenerative medicine center, the
answer is not exactly simple. It has several facets, and in my opinion the most important foundation
for a business that can stand the test of time is the practical and theoretical training required for the
administration of cellular products. Through this training, one can learn in a no-pressure environment
how to administer cellular products in a safe and effective way.

Knowing the treatment protocols available to you as a regenerative medicine practitioner and having
the practical skills to administer them are of paramount importance-- both to the results of each
patient, and to the final success rate of your medical practice. It is not only about learning how to
succeed in isolating and processing the cells in your clinic, but also about knowing the best ways to
apply these isolates, and the foundational knowledge needed to know which treatment is best to use
for each patient.

In addition to clinical and professional training, which is important for keeping your patients both
happy and healthy, great attention to detail must be paid to the quality of business management,
marketing, and operation direction of a regenerative medicine center. After all, it is no good to have
the most skilled physicians if you are unable to get patients through the door. These are decisive
factors that require study on the part of you and your team, in order to ensure the best possible results
for each patient that wants to receive the benefits of regenerative medicine.

Over the last twelve years of our organization’s activity, our main focus has been to promote quality
standards and good practices in the field of regenerative medicine. For this, in the way of training, we
have designed several face-to-face courses and online educational materials, intended to guide
doctors in the correct application of cellular therapies that can serve in treating a wide array of
conditions and illnesses.

Among the courses most recommended by us at www.issca.us are: ISSCA OnSite,

ISSCA Hands On Autologous, ISSCA Hands On Allogeneic, ISSCA OnLinr Autologous,
ISSCA OnLine Allogeneic.

See Courses

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The Basic Equipment of a
Cellular Therapy Center
In order to help you get familiar with the equipment required to establish a
regenerative medicine center, we’ve listed several of the more basic pieces of
equipment-- these can open the door to a wide variety of different cellular
therapy-based treatment options to your patients.

Biosafety Cabinet
It was originally designed in order to allow physicians to
process tissue samples on-site, as it has a compact build that
also maintains sterility. There are several makes and models
available, but we recommend the ISO Class 5 Cabinet. This is
because it employs a 2-stage filtration process, which can
result in up to 99.97% filtration efficiency on particles 0.3
microns or larger.

Photoactivation Device
This equipment uses a powerful LED (Light Emitting Diode)
light, which has been found to result in the photoactivation
of both stem cells and PRP. It is essential to guarantee the
effectiveness of cellular therapy treatments, due to its
photo-modulating action on stem cells. It can also be used
to prepare PRP, due to its ability to modulate the increases
in cytokine release.

Shaking Incubator
The Shaking-Incubator is mainly used for autologous cell
cultures with adipose tissue cells-- it allows for both stable
shaking and precise 37 degree temperature control. This
simulates ideal human body conditions, and prevents cells
from losing viability and dying during the process of
enzymatic dissociation.

See Equipment

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The Basic Equipment of a
Cellular Therapy Center
In order to help you get familiar with the equipment required to establish a
regenerative medicine center, we’ve listed several of the more basic pieces of
equipment-- these can open the door to a wide variety of different cellular
therapy-based treatment options to your patients.

Centrifuge with Variable Rotor

This centrifuge is used in the cultivation of cell cultures,
tissue isolation, and blood separations. Density gradient
separation is essential, and crucial to achieving high
concentrations of cell products. Choosing a centrifuge
that fits your specific needs is key for a regenerative
medicine clinic, as it is one of the most important pieces
of equipment you’ll purchase.

Automatic Cell Counter

Although an automatic cell counter is not a necessary
piece of equipment, per se, you will quickly find that it is
indispensable when you need to validate the quality of
the treatments you perform, and the products that you
use to do so. The Automatic Cell Counter provides
accurate live/dead cell count results within 7 seconds of
beginning the count.

To see more about our

products visit
www.adimarket.net

See Equipment

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Blueprint for a
Regenerative Medicine Office
Directions on just how to construct a cell lab within a medical office is one of the most common
questions we get from potential regenerative medicine practitioners-- these people want to begin
practicing cellular therapies in their own clinic, but are unsure what they need in order to do so. The
idea of a cell lab within a medical office does not have to be extremely complicated, nor does it have
to pose an insurmountable obstacle.

We have created a template that has been specifically designed to support the assembly of
regenerative medicine centers anywhere in the world. This presents the layout of a typical cellular
therapy center where laboratory equipment has already been installed.

This proprietary design provides the flexibility needed to offer multiple services to patients, depending
on which branch of the field a physician might want to explore. It accommodates projects that can
vary vastly in volume and sample size, while simultaneously maintaining effective and efficient
processing times and costs.

Standard procedure room for

tissue extraction and
administration of cell
therapies.

One of the main elements to take into account when setting up a laboratory for in-office processing
of adipose tissue, bone marrow, or allogeneic cellular components, is the sterility of the processes.
Maintaining sterile practices is the single most important step one can take to ensure viability. We
recommend choosing a room with restricted access, with a laminar flow cabinet or biosafety cabinet
as an essential element. If you do not have an operating room, the following is a diagram of an ideal
configuration for a cellular therapy unit within a clinic.

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Patient Acquisition
After you’ve finished installing your cellular therapy processing suite and arming yourself and your
staff with the knowledge on which cellular therapy to use, as well as which equipment and kits to use
in conjunction with them, your medical team will face one of the final hurdles-- having patients
actually walk through your doors for a consult or treatment.

Many doctors forget the business factor of clinics that offer ‘cash-based’ treatments, in which the
patient pays out of pocket. In the undertaking of a regenerative medicine center, in addition to the
clinical lens, we recommend establishing a training program with a commercial focus, that has the
tools and ideas needed to promote your center in the health market.

Among the most important points to keep in mind, we always recommend learning communication
strategies based on social media-- this is because they provide cheaper dissemination of information
than many of the once-standard advertising avenues. This is in addition to insisting on a proper
foundation of customer service and efficient internal processes to provide the best experience to
patients.

Our organization has also designed a training program that is focused on the commercial sector of the
industry, which includes, in addition to those topics previously discussed, specific strategies intended
to sell your packages or treatment plans. Here are some of the topics included in our medical
marketing courses:

How do conduct a successful consultation

Phone-Call Training
Managing Patient Expectation
Answering Frequently-Asked-Questions
Forming a Digital Presence (Website, Landing Pages, Social Media etc.)
Follow-Up Strategies for Patients
How to Manage Paid Ad Services
Email Marketing

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Promoting Standards of
Practice in Regenerative Medicine
Just as with any other branch of medicine, regenerative medicine needs the presence of regulations
and adequate training bodies to prove its effectiveness and normalize results garnered. Our
organization, the International Society for Stem Cell Applications, aims to make the benefits of
regenerative medicine available to interested physicians, at both the medical practice and clinical
levels.

ISSCA’s goal is to become the gold standard in regenerative medicine, to become a leader in the areas
of education, research, training, and the certification of healthcare professionals currently
administering cellular therapies as regenerative medicine practitioners. The fundamental idea of the
organization is to promote exchange between doctors from all over the world to define standards of
quality and excellence. In order to grow its reputation as a viable alternative to current standards of
practice, the field of regenerative medicine must have regularized treatment protocols.

If you are a medical professional who dreams of accruing new experiences and broadening your
knowledge in the field of regenerative medicine, ISSCA will give you access to the world’s largest
community of regenerative medicine practitioners and researchers, whose objective is to treat
degenerative diseases and alleviate human suffering. To further this end, we strive to incorporate the
most modern advances in the science and technology of regenerative medicine.

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 Making the Benefits of Regenerative Medicine a
Reality for Doctors and Patients Around the World.

Benefits Offered to ISSCA Members:

Scientific Support
Access to a Community of Similar-Minded Practitioners of Regenerative Medicine
Certification and Access to Validated, Peer-Reviewed Treatment Protocols
An Ever-Continuing Education for Members of the Organization
Support in Promoting the Benefits of Regenerative Medicine

More information
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