PLACENTA FOR COSMETIC PURPOSE AND CELL REGENERATION

PLACENTA FOR COSMETIC PURPOSE AND CELL REGENERATION

1.0        INTRODUCTION

Placenta is an organ that connects the developing fetus to the uterine wall to allow nutrient uptake, waste elimination and gas exchange via the mother blood supply. The placenta functions as a fetomaternal organ with two components: the fetal placenta, or (Chorion frondosum), which develops from the same blastocyst that forms the fetus, and the maternal placenta, or (Decidua basalis), which develops from the maternal uterine. It has a dark reddish-blue or crimson colour. It connects to the fetus by an umbilical cord which contains two umbilical arteries and one vein. It is an organ that stores many active molecules such as various nutrients and immune substance that are required for life sustenance and proliferation of fetus.

Nowadays, placenta in addition to known function in utero, it is said to have other various functions. Human and animal placenta extracts are widely used in various consumer products such as pharmaceuticals, cosmetics, hair care products and health tonic. It is claimed that placenta extracts contain enzymes, nucleic acids, vitamins, amino acids, steroids, fatty acids and minerals which can promote as anti-aging, enhance cell regeneration and boost the immune system. It is also claimed the placenta produced one substance namely binucleate cell which is believed as an active substance that used to treat various disease and improve health.

Currently there are many placenta products in the market which are either extract from human placenta or animal. Many of the products are claimed to be safe and effective for health. Data on the exact purpose of the placenta extract is not well documented and difficult to find.

This technology review was conducted following a request from National Pharmaceutical Control Bureau, Ministry of Health (MOH) Malaysia who received a proposal from a company to obtain license for marketing the product as health supplement.

2.0        OBJECTIVE/AIM

The objective of this technology review is to assess the evidence on the safety and efficacy/effectiveness of using placenta for cosmetic purpose and cell regeneration.

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3.0        TECHNICAL FEATURES

Nowadays, there are various forms of placenta preparations in the market such as pills / capsule, injection, cream, shampoo and etc. All of this products claimed placenta extract have an active substances which is able to cure many diseases and improve the quality of health. However the safety and efficacy/effectiveness of these products are still not known.

The placenta serves as a source of protein and hormone, predominantly estrogen and progesterone in the cosmetics in which it is used. Cosmetic that use hormone extracted from the placenta, such as Hyaluronic acid and hydrolysed protein, claimed to help to promote tissue growth, which is said to be effective in removing wrinkles. In terms of health, placenta containing Human chorionic gonadotropin (HCG) hormone, a naturally produced substance which is used in the treatment of some diseases such as obesity, asthma, gastritis, neurosis, heart damage, hyperlipemias, hypercholesterolemia, eczemas, glaucoma, alcoholism, pelvic infections in women, heal open wounds, including burn injuries and more recently a cancer-like tumor appearing in AIDS patients, named Kaposi sarcoma etc.

According to the document provided by the applicant, ruminant placenta have trophectodermal epithelium which consists of mononucleate cells and binucleate cells. Mononucleate cell serves as a medium of exchange of nutrients and binucleate cell as an important substance in the study have a function in producing hormones such as progesterone, placenta lactogen, Pregnancy Associated Glycoprotein (PAG) and Prolactin Related Protein 1. These binucleate cell are thought to have important effects to cure various diseases and improve health.

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4.0        METHODS

4.1.       Searching

Electronic databases searched through the Ovid interface:

• Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R) 1946 to Present

• EBM Reviews – Cochrane Central Register of Controlled Trials July 2013

• EBM Reviews – Cochrane Database of Systematic Reviews 2005 to July 2013

• EBM Reviews – Cochrane Database of Systematic Reviews – 2005 to August 2012

• EBM Reviews – Health Technology Assessment 3rd Quarter 2013
•  

Other databases:

• PubMed

• Other websites: US FDA, INAHTA, MHRA

General database such as Google and Yahoo were used to search for additional web-based materials and information. Additional articles retrieved from reviewing the bibliographies of retrieved articles or contacting the authors. The search was limited to articles on human. There was no language limitation in the search. Appendix 1 showed the detailed search strategies.

4.2.     Selection

A reviewer screened the titles and abstracts against the inclusion and exclusion criteria and then evaluated the selected full-text articles for final article selection. The inclusion and exclusion criteria were:

Inclusion criteria

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Exclusion criteria

Relevant articles were critically appraised using Critical Appraisal Skills Programme (CASP) and evidence graded according to the US/Canadian Preventive Services Task Force (Appendix 2).

5.0        RESULTS AND DISCUSSION

There was no retrievable scientific evidence on the safety and efficacy/effectiveness of placenta for cosmetic purpose and cell regeneration form electronic databases.

5.1.       Efficacy/effectiveness

There was no retrievable scientific evidence on the efficacy/effectiveness of placenta for cosmetic purpose and cell regeneration from electronic databases.

5.2.       Safety

There was no retrievable scientific evidence from the journal database on the safety of placenta for cosmetic purpose and cell regeneration. However, the FDA maintains that placenta extract may be potentially hazardous and its use is subjected to restrictions and requirements of warnings due to its side effect reported when used in human.

5.3        Limitation

Our review has several limitations. The selection of the studies and appraisal was done by one reviewer. Although there was no restriction in language during the search, only English full text articles were included in the report. Many of the information available are from laboratory studies.

6.0        CONCLUSION

There was no retrievable scientific evidence on the safety and efficacy / effectiveness of placenta for cosmetic purpose and cell regeneration from electronic databases.

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8.0        REFERENCES

1. H Renuka. Therapeutic applications of the human and animal placenta. International Journal of Futuristics Science Engineering and Technology. 2013;1(2):89-91
2. Alternative uses for placenta-Wikipedia, the free encyclopedia. Available at http://en.wikipedia.org/wiki/Alternative_uses_for_placenta. Accessed on 5/8/2013

9.0        APPENDIX

9.1        Appendix 1: LITERATURE SEARCH STRATEGY

Ovid MEDLINE® In-Process & Other Non-indexed Citations and Ovid MEDLINE® 1948 to present

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9.2        Appendix 2

HIERARCHY OF EVIDENCE FOR EFFECTIVENESS STUDIES

DESIGNATION OF LEVELS OF EVIDENCE

• Evidence obtained from at least one properly designed randomized controlled trial.

II-I          Evidence obtained from well-designed controlled trials without randomization.

II-2        Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one centre or research group.

II-3        Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence.

• Opinions or respected authorities, based on clinical experience; descriptive studies and case reports; or reports of expert committees.

SOURCE:     US/CANADIAN PREVENTIVE SERVICES TASK FORCE (Harris 2001)