The ephemeral organ placenta supporting the baby's growth and development in the mother’s womb contains a wide range of biologically active substances and materials. Prof. V.P. Filatov, an eminent Russian ophthalmologist, continued research and proposed the principle of tissue therapy. After many clinical experiments Filatov was convinced that any tissue human or animal could be used to obtain curative effect.

In the recent past Albert David Limited took the onus of extensively researching on Human Placental Extract and launched Placentrex Injection in the year 1954 after acquiring necessary regulatory approval. The Company initiated industry-academia collaborative research that led to the identification of bio molecules like PDRN, Fibronectin like peptide, and glutamate. These biomolecules have an established role as an anti-inflammatory agent. Some of the ingredients are also being quantified and is under research and regulatory finalization.

Placentae are collected from Government approved hospitals that are screened for HIV as per the NACO India Guidelines. Very stringent methods are adopted in the manufacturing of Placentrex. During the process the extract is heated to a temperature of 121ºC under pressure of 15 lbs for 40 min more than once. HIV, HBV, HCV are killed and destroyed at this high temperature. This is in accordance with internationally acclaimed textbooks namely

a). Jawetz, Melnick and Adelberg’s Medical Microbiology 24th Edn . Mc GrawHill, Medical USA Which says, HBV is sensitive to high temperature gets killed at 100 C for 1 min. HIV is readily inactivated by heat treatment at 56 C for 10 min.

b). Topley and Wilson Microbiology and Microbial Infection 10th Edn Virology Vol.2 Wiley Blackwell USA Which says HCV is inactivated by dry heat treatment at 80°C or wet heat treatment at 60ºC for 8 min.

c). Text book of microbiology by Dr. Subhash Chandra Parija, MD PhD DSc, FRCPath, JIPMER, Pondicherry Elsevier (India) Pvt. Ltd., 2009 Which says, HBV is killed at 100°C for 1 min.

As per the guidelines given by the DCGI the drug is screened for HIV using ELISA of Individual placenta, Pooled placental extract & Finished Product.

As a matter of abundant precaution random samples of different stages of Placentrex were tested at SDMH Blood Bank, Jaipur by more recent PCR method for HIV I & II, HBV, HCV using COBAS S 201system (Make Roche) and all the samples tested this far were found to be free from virus. Accordingly the label claim on the drug appears as “HIV antibody free HCV antibody free& Hepatitis B Surface Antigen free.”

The Company is strictly adhering to the guidelines laid down for the manufacturing process that was certified by Department of Virology, School of Tropical Medicine Kolkata and later on granted patent by The Govt of India in 2006.

Major indication of the Drug-

[A] Placentrex injection is used to treat and defer recurrence of Pelvic Inflammatory Disease (PID)

Pelvic Inflammatory Disease (PID)

PID defined as inflammation of upper genital tract including the endometrium fallopian tubes and / or contiguous structures from microorganisms ascending from the lower genital tract may lead to organic and psychological sequelae. Even after treatment with appropriate antibiotics the clinical course of PID remains varied and the squealae also differs widely. Management of squealae includes periodic courses of anti-biotic, steroids and surgery. The incidence of PID is on the rise because of increased incidence and reportage of STDs caused by chlamydia. No individual sign or symptom is pathognomic of PID. Lower genital tract microscopy, culture and serology is also inconclusive. Because there are no reliable early diagnostic criteria for PID, early empirical treatment is recommended by CDC. Treatment is mainly aimed at alleviating symptoms, and preventing the disabling squealae like infertility. Anti-microbial therapy improves prognosis for fertility but actual fertility results are not satisfactory. Antibiotics alone cannot prevents sequelae of salphangitis Placentrex contains biomolecules like PDRN, Fibronectin like peptide and Glutamate that directly help to control inflammation of PID.

Rationality

PDRN in Placentrex suppresses the pro inflammatory chemical mediators from the kallekrein kinin system, coagulation system complement systems. PDRN also enters into the microbes and interfering their replication machinery exerting bacteriostatic effect.

‘Placentrex’ shows stabilization of trypsin against autodigestion as one of the peptides of the extract binds very strongly with the protease and exerts a debridement action. Debridement removes foreign bodies and necrotic tissues and reveals healthy, bleeding tissues so the wound can heal.In the inflammatory phase Placentrex expresses fibronectin like activity produces cross linkage along with fibrin to form a plug and thus prevent blood loss. Facilitation of trypsin activity may also help in opening of tubes after a bout of inflammation. Collagenase expression of Placentrex helps to cause lysis of bands and adhesions that are formed due to chronic inflammation.
Glutamate in Placentrex was also found to induce chemokinesis of the neutrophil, though the stimulation of chemotaxis was more pronounced.

Clinical Studies

As per the CDC guidelines 2010 the minimal criteria of diagnosis of PID were:

a). Cervical motion tenderness
b). Uterine tenderness
c). Adnexal tenderness

Clinical studies conducted at a Lucknow medical college (2008) and at AIIMS New Delhi (2010) have shown that the above symptoms were significantly lowered with Placentrex treatment compared to the conventionally treated group.
A 14-days course of therapy was able to prevent recurrence significantly over conventional treatment.

Wrapping Up

Anti-microbial therapy improves prognosis for fertility but actual fertility results are not satisfactory

Antibiotics alone cannot prevent sequelae of PID.

Well-established anti-inflammatory actions of the biomolecules present in placentrex treat and defer recurrence of PID

The drug exerts debridement action by stabilizing the local trypsin – a property that helps in opening of fallopian tubes blocked by inflammation

Collagenase expression of Placentrex helps in the lysis of bands and adhesions that are formed due to chronic inflammation

The drug is safe without any adverse event being reported so far. It is extremely patient compliant and economical. The drug addresses the minimal criteria for PID treatment as laid down by CDC 2010

[B] Placentrex Gel : it is a controlled wound healer and a tissue regenerator

Healing of wound is a process wherein different events operate in overlapping phases. These are inflammation (debridement), proliferation and regeneration (epithelialization). Debridement comprises of detachment and removal of necrotic tissue and foreign materials interfering with normal healing (Falanga, 2001; Steed et al., 1996). They are removed to create a platform for healthy tissue to grow. This phase is the foundation for the subsequent rebuilding of healing tissue. During proliferation, a filament or template is constructed based on which tissue matrix forms.The matrix material is initially made up of fibrinogen and fibronectin (Diegelmann and Evans, 2004; Witte and Abarbul, 1997). Cell proliferation aimed at the generation of newly replaced tissues to fill and resurface the defect dominates this phase. Finally, regeneration and remodeling occurs where readjustments take place to regain tensile strength of the newly formed healthy tissues (Gurtner et al., 2008).

There is a lacuna of medications that directly brings about wound healing. The main stay of wound therapy are the anti-microbials that exerts a control over the infection but has no direct role on tissue regeneration, new vessel formation, epithelialisation leading to the closure of wound. The process of healing is at the disposal of the immune system of the body. Placentrex – the original research product of Albert David Limited, India, is a drug obtained from fresh term healthy human Placenta tissues containing:

1. Fibronectin Type III like peptide
2. Fragments of nucleotides PDRN, NADPH etc
3. Amino acids - glutamate
4. A water-soluble peptide with CRF like activity (research under progress)

Placentrex directly facilitates the process of wound healing through these active biomolecules . Extensive Fluorescent screening showed that ‘Placentrex’ contains biologically active NADPH that facilitates nitric oxide mediated wound healing by stimulating nitric oxide synthase enzyme to its active form which is a pre-requisite for wound healing, NO helps in 1) Killing Bacteria 2) Debrides Necrotic Tissues & 3) Helps in re-epithelialisation (Datta P, Bhattacharyya D. 2004 ) .

Proteases play important roles in wound healing by regulating the balance between tissue degradation and regeneration (Lund et al., 1999; Moali and Hulmes, 2009). Slow removal of the necrotic tissue due to insufficient protease activity delays the onset of healing. On the other hand, an excess of protease during proliferation destroys growth factors and their receptors, as well as inhibit angiogenesis and breakdown granulation tissue resulting in tissue damage (Schultz and Mast, 1998; Trengove et al., 1999).

Study reports using both biochemical and biophysical tools have shown that peptide fractions ( constituting of human fibronectin type III peptide ) present in placental extract reversibly inactivates trypsin, preventing its auto-digestion and thus stabilizing its activity. Tripsin stabilizing activity of fibronectin type III like peptide in placentrex is crucial for regulation of proteolytic activity and is critical to efficient scar less repair (Chakraborty PD, Bhattacharyya D. 2005, De and Dutta Chakraborty 2010)

It has been reported earlier that human fibronectin type III peptide also has high efficacy of stimulating cell migration and wound repair (Nath and Bhattacharyya, 2007; Cheng et al., 1988).

There are many published reports of use of purified human placental extracts by various specialty doctors in clinical medicine like obstetrics & gynecology, physicians orthopedic surgeons, general surgeons. Purified extract of human placenta has been found to be beneficial on topical application in the management of non-healing wounds. Human placental extracts have shown to help collagen synthesis leading to potent healing of wounds in rats (12).

Purified extract of human placenta is commercially available in the Indian market as injections & gel for topical application. In the present study we plan to evaluate the wound healing potential of topical application of placental extract gel in surgical / diabetic / venus / and other wounds.

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