LIVE CELL THERAPY AND RELATED LIVE CELL THERAPY AND RELATED INTERVENTIONSINTERVENTIONS

Stephen Holt, MD LLD(Hon.) ChB., PhD, DNM, FRCP (C), MRCP (UK), FACP, FACG, FACN, FACAM, KSJ

- Distinguished Professor of Medicine (Emeritus)- Consultant, Villa Medica Project and HMC Bangkok- Visiting Professor, Mae Fah Luang University

DISCLOSUREDISCLOSURE• Consultant to the Villa Medica Project which is

centered at Villa Medica, Edenkoben, Germany• Villa Medica performs classic live cell therapy

using fresh animal fetal tissues in a facility licensed by the German government

• Scientific Advisor to Natural Clinician LLC (non-compensated)

• Live cell therapy is not an approved treatment in the USA

What is Live Cell Therapy?What is Live Cell Therapy?

• Animal fetal tissues are obtained from a newborn sheep carcass that has been freshly slaughtered in house (clinic).

• The fetal tissues are prepared into fresh live cell suspensions which are injected into a patient within one hour of their collection from the fetus of a sheep.

What is Live Cell Therapy?What is Live Cell Therapy?

• Live cell therapy in its classic form involves the use of “live cells.”

• Live cell therapy is not stem cell therapy per se but animal fetal cell suspensions are enriched with stem cells.

• Live cell therapy has been described by many different terms that cause much confusion among physicians and patients.

Confusing TerminologyConfusing Terminology

• Live Cell Therapy• Embryonic Cell Therapy• Stem Cell Transplantation• Translational Therapy• “Brinkley Goat Gland

Treatments”• Frankenstein Treatment• Heteronucleic Cellular

Treatment

• Glandular Therapy• Variant Cell Therapy• Zellentherapie• German opotherapy• Homeopathic

Organotherapy• Xenogenic Cell Therapy• Biological Therapy

Confusing TerminologyConfusing Terminology• Fresh Cell Therapy• Organotherapy• Embryonic Cell

Transplantation• Tissue Specific

Transplantation• Cellular Suspension

Therapy• Tissue Transplantation

• Xenograft Therapy • Cell Transplantation• Frishzellen

arzneimittel• Xenotransplantation• Fetal Tissue

Transplantation• Frisczellentherpeutica• Niehan’s Therapy

What is Live Cell Therapy?What is Live Cell Therapy?• Classic live cell therapy was originally

described by Paul Niehans MD, but he and others switched treatments to the use of freeze-dried cells which are not “live cells.”

• Villa Medica gives only classic live cell therapy with fresh animal fetal tissues. This is true fresh cell therapy.

• As many as 7 million patients have undergone live cell therapy since 1931.

Mechanism of Action of Live Cell Mechanism of Action of Live Cell TherapyTherapy

• Unlike human stem cell therapies, animal live cells do not undergo significant degrees of engraftment in human recipients.

• The administered cellular material disintegrates rapidly (hours) after injection and it provides a mixture of biological signals that are believed to reprogram cellular functions. This is the basis of “Niehans concept of cellular revitalization.”

I acknowledge in this presentation the lifetime work of Burkhard Aschhoff MD, who has led the live cell therapy projects at Villa Medica since 1991 in succession to Alexander Gali, MD.

Dr. Aschhoff does not recognize freeze-dried cellular material as fresh cell therapy.

ACKNOWLEDGEMENTACKNOWLEDGEMENT

Live Cell Therapy involves the injection of fetal animal cells into the human body to reprogram cells.

Injected fresh animal fetal cells disintegrate and present biological signals.

Fetal cells from sheep do not generally cause significant immunogenic effects.

DEFINITIONDEFINITION

LIVE CELL THERAPYLIVE CELL THERAPY

REVITALIZE

REGENERATE

Degenerated or diseased

cells

Stimulated or reprogrammed cells

Live Cell injection

A Physician from Switzerland who developed the modern practice of Live Cell Therapy in1931 and successfully applied it to thousands of patients.

In 1955, he treated Pope Pius XII. He was appointed to be a member of the Vatican Academy of Science, following in the foot-steps of Sir Alexander Fleming, the father of penicillin.

The Father of Live Cell The Father of Live Cell Therapy Therapy Dr. Paul Niehans, 1882-1971

Treatments Number oftreated patients

% of totalPatientstreated

Positive Outcomes

(%)

No or minimalimprovement

(%)

Age-related illnesses 34373 76 94 6

MultipleSclerosis

5427 12 81 19

Genetic Defects 2715 6 92 8

Developmental Disturbances In Children

1357 3 99 1

Psychological Illnesses

1356 3 88 12

90.8% of treated patients achieved positive outcomes

•Treatment tissue is harvested from the joints of unborn sheep.•Filtration of solid particles takes place after processing the tissues into a suspension.•The resulting fluid is then injected into joints.

Retrospective Analysis Performed on Data Retrospective Analysis Performed on Data Generated by 7,620 Patients Over a 7-Year Generated by 7,620 Patients Over a 7-Year PeriodPeriodA total of 19,432 joints were treated:

• 43% knee joints

• 20% joints of the spinal column

• 18% joints of the shoulder, elbow, fingers, or toes

• 17% hip joints

• 2% ankle joints

In 50% of patients up to 2-3 joints were treated

Patients noted improvement in symptoms beginning the second day post-treatment and continued improvement up to the 21st day post-treatment.

Failure rate 2.8% 23

Treatment ResultsTreatment Results• The pioneers of live cell therapy admit the lack

of controlled trials, uniformity of treatment protocols and the reporting of incomplete outcome data.

• In aggregate there are more than 1,000 articles describing the benefits of live cell therapy in several languages and at least 5 classic textbooks written by Paul Niehans MD, Siegfried Block MD, Franz Schmid MD, Alexander Gali MD, E. Michael Molnar MD.

Treatment ResultsTreatment Results

• Indications for live cell therapy have included almost all diseases, e.g. congenital disorders, genetic defects, arthritis, cardiovascular disease, cancer, immune disorders etc.

• Consistent reporting of beneficial outcome is apparent in much of the literature on live cell therapy, but some experiences have questioned the benefit of this treatment in several disorders, e.g. chromosomal defects.

Treatment ResultsTreatment Results• A balance of evidence implies that freeze-dried

cellular material is more immunogenic than fresh “alive” cells, used in classic techniques.

• Overall, the procedure is considered to have a high margin of safety, but uncommon adverse effects have been variably described in relatively small numbers of patients, e.g. acute allergic response, induction of autoimmune-like disease and transmission of microbial infection.

Treatment ResultsTreatment Results

• Live cell therapy is not to be used as a simple in-office procedure. It needs to be performed in a controlled environment, with safety measures and support services.

• It seems clear that the skill and experience of the operator and adjunctive care has a major influence on the outcome of therapy.

Treatment ProtocolsTreatment Protocols

• Careful patient evaluation and selection is required. There are absolute and relative contraindications.

• A comprehensive holistic care program must be in place in the live cell treatment facility, e.g. nutritional support, expert nursing care, detoxification programs and strict adherence to standard operating procedures and safety precautions.

Treatment ProtocolTreatment Protocol• The patient rests after the injections for a period

of 24 hours (bed or chair rest).• There are several do’s and dont’s which are

obvious precautions, e.g. vigorous exercise avoided, no smoking, no unnecessary use of drugs etc.

• The patients response occurs in phases. Within 24h, a sense of wellbeing is common. At 2 weeks, a reaction phase occurs with tiredness and temporary reactivation of symptoms. Beneficial outcome is apparent after months.

Treatment ProtocolTreatment Protocol• Meticulous follow up is necessary with

precautionary checks.• Monitoring and pre-procedure assessments

are most often performed by referring physicians who play a pivotal role in the overall biological treatment programs.

• Decisions to undergo further live cell treatments depend on several factors.

Treatment Protocol: Cell SelectionTreatment Protocol: Cell Selection• Combinations of animal cells are used

and selected based upon the disease under treatment and the careful assessment by the live cell therapist.• The principles of organ specificity are

extremely important in cell selection.• The underlying philosophy involves the

aphorisms of Paracelsus (like healing like).

Related Interventions

• Human stem cell therapies• Oral glandular therapies• Injection of tissue extracts• Topical applications of cell suspensions• Use of many different tissues with a

focus on thymus, spleen and placenta…

Related InterventionsRelated Interventions

• The use of in-situ adult stem cells for treatment of disease.

• Adult stem cells are ubiquitous.• These cells live in niches and they can

become dislodged, circulate, recruited by ailing or diseased tissue, exert multipotent potential to differentiate into adult somatic stem cells.

Related InterventionsRelated Interventions• Drugs, e.g. GCMSF can dislodge marrow

stem cells, but nutraceuticals may be even more effective in promoting stem cell dislodgement into the circulation.

• Proprietary and patented stem cell support formulae have been developed in the Villa Medica project. These natural, synergistic combinations involve the use of seaweed, vitamin D-3, blueberry extract, carnosine etc.

Related Interventions: Related Interventions: NutraceuticalsNutraceuticals

• Much in-vitro work supports the use of combination nutraceuticals as enhancers of stem cell structure and function.

• Many testimonials exist on the benefit of the use of nutraceutical stem cell enhancers, e.g. blue green algae.

• Human studies confirm stem cell release by nutraceuticals, but more clinical outcome data are required. The use of these agents is rational.

Specific Interventions: PlacentaSpecific Interventions: Placenta

• Placenta extracts, whole forms by injection, oral or topical use has entered the field of cosmetic medicine.• Approved drugs made from extracts of

placenta are sold in Japan.• Reported claims of benefit of placental

therapies are legion, but more study is required.

ConclusionsConclusions• There is much renewed interest in live cell therapy

and related interventions • Increasing knowledge about cellular cognition and

communication can result in the design or application of biologicals for disease treatment.

• Overall, classic live cell therapy has a high margin of safety and a strong precedent of benefit that has been reported over a period of 80 years.

• More controlled research observations are justified given the problems posed by the use of human stem cells.