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MSCs are multipotent cells that can not only self-renew but also transform into multiple tissue types such as bone, cartilage, fat, etc. other than blood-related cells. Further, these cells are also known to produce a large number of soluble growth factors and cytokines that can signal to other cells and tissues to accelerate the regenerative repair process when tissue is damaged by trauma or disease. LifeCell’s proprietary mesenchymal stem cell product, MesoCel, is derived from the umbilical cord and is under investigational use in authorized clinical trials.

Origin

MSCs are isolated by primary explant culture from donated umbilical cords, expanded further in 2D cell culture flasks, and then pooled together to form the master cell bank

Donations were received from mothers below age 30 years, having healthy pregnancies, and meeting the donor eligibility qualification criteria

Processing

Large scale 3D culture based on bioreactors were used for expansion of cells incorporating animal-free media to minimize the risk of infectious agents

Processing was carried out within a Good Manufacturing Practices (GMP) compliant facility at Chennai, in clean rooms with air classification of ISO 4 cleanrooms or better ( <10,000 particles/cubic foot)

Preservation

Isolated cells were harvested and preserved with cryopreservation media containing 5% recombinant human serum albumin, plasmalyte, and 10% Dimethyl Sulfoxide

Final drug product contains a dosage of 100 million MSCs in 10 ml of solution, stored in a shock-resistant transparent vial

Testing

MesoCel meets the criteria for evaluating the quality, safety, and efficacy of MSCs as suggested by International Society of Cell & Gene Therapy (ISCT) 2019 guidelines*

Administration

MesoCel is a prescription based therapeutic and is meant to be administered intravenously in either single or multiple doses (depending on clinical indication)

Product is cryoshipped to the infusion center and is to be thawed before patient administration

No Matching Required

Since MSCs have low immunogenicity they do not require any blood group or immune matching prior to usage thus making it a universal use biologic drug product

Regulatory Approvals

MesoCel has a license from the Drug Controller General of India and is approved for investigational use in several leading hospitals in the country, thus providing much-needed assurance of usage - unlike preserving tissues in private banks which may never see future use due to lack of requisite approvals

LifeCell is the first stem cell bank in India to establish in-house capabilities to manufacture MSCs in large-scale bioreactors, and also obtain regulatory approval from local authorities to investigate its safety and efficacy in human volunteers.

Cost Effective

A single 3D bioreactor batch can yield over 20 billion cells far exceeding the quantity generated from 2D expansion culture using flasks, thus making it extremely cost-effective for large scale use

Better than Adult Sources

Regenerative repair capacity of MSCs diminishes with age and therefore MesoCel, which is sourced from newborns, has the highest proliferation rate which is 3-4 times higher than that of adipose tissue or bone marrow-derived MSCs

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Off the Shelf

Unlike obtaining MSCs from own tissue sources which could require invasive surgeries or need time to culture from preserved raw tissues, MesoCel is obtained from discarded birth tissues and is designed to be readily available as a therapeutic so that it can be accessed at any time for immediate clinical use

Given the multipotent potential of mesenchymal stem cells they’re being medically investigated in over 1000+ clinical trials globally, and have either recently obtained market approvals (India, EU & Japan) or have moved into final stages of market approval (phase 3 in US). MesoCel seeks to build on this and aims to be a follow on product catering to patient needs in India and beyond, starting with management of COVID-19.

Approved Indications of MSC’s

Complex perianal fistulas with non-active/mildly active luminal Crohn’s disease (Alofisel)

Critical Limb Ischemia (Stempeucel)

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Phase 3 Indications of MSC’s

Acute Graft vs Host Disease (Remestemcel)

Acute Respiratory Distress Syndrome (Remestemcel)

Large scale 3D culture based on bioreactors were used for expansion of cells incorporating animal-free media to minimize the risk of infectious agents

Chronic Lower Back Pain (Rexlemestrocel-L)

Chronic Heart Failure Reduced Ejection

Fraction (Rexlemestrocel-L)

Ischemic Stroke (MultiStem)

Osteoarthritis (Cymerus)

MesoCel Covid-19 Trial

40 patients phase 1/2 clinical trial

Actively recruiting patients now across its approved clinical sites

Why Choose LifeCell?

Utilizes Advanced Technologies

Produced using advanced biotechnology techniques such as 3D-Cell Culture for Cell Expansion, Tangential Flow Filtration for Cell Harvest, and Self-Seal Impact Resistant Cryovials for Cell Packaging

Licensed & Ethics Board Cleared

First Cord Blood Bank in India to receive clearance from DCGI and IC-SCRT to initiate clinical trials for evaluation of safety and effectiveness of Umbilical Cord derived MSC’s

Quality Assurance

Follows stringent quality standards for the donor, cell bank, and final product qualification and release designed to meet criteria from ISCT and FDA

Frequently
Asked Questions

Frequently Asked Questions

Wish To Know More?

MSCs are multipotent stem cells that can divide to self-renew and specialize into a variety of tissues such as bone, cartilage, adipose tissue (fat cells), connective tissue, and muscle, bone cells, cartilage, muscle cells, neural cells, Skin cells, and corneal cells.

MSCs are stem cells that can differentiate into a variety of cell types and can be extracted from a variety of sources that includes bone marrow, umbilical cord (Wharton's Jelly), fat (adipose tissue), amniotic fluid (the fluid surrounding a fetus).

MSCs don't show the negative immunological response. This ability allows them to be transplanted without the risk of rejection. These transplants significantly boost the body's natural healing powers while also providing powerful anti-inflammatory and immunosuppressive effects.

MesoCel is LifeCell's proprietary mesenchymal stem cell product consisting of cultured cryopreserved derived from the human umbilical cord of healthy donors and is under investigational use in authorized clinical trials.

The active ingredient of MesoCel is expanded human umbilical cord derived mesenchymal stem cells which promote epithelial and endothelial repair, alveolar fluid clearance, and bacterial clearance and exert anti-inflammatory and antiapoptotic (prevents cell death) effects. MSCs are capable of treating variety of conditions like COVID-19, ARDS, Crohn’s disease, Multiple Sclerosis, Lupus, COPD, Parkinson’s, and many more

LifeCell has become the first stem cell bank to get DCGI’s approval for using MSCs derived from the umbilical cord tissue. LifeCell has used umbilical cord tissue derived MSCs (MesoCel) because it has the highest proliferation rate which is 3-4 times higher than that of adipose tissue or bone marrow-derived MSCs. Regenerative repair capacity of MSCs diminishes with age and therefore in MesoCel we use umbilical cord tissue which is sourced from newborns. It is easy to collect the umbilical cord tissue as it is collected from the discarded birth tissues. And it is designed to be readily available for therapeutic use and also already mentioned can be accessed at any time for immediate clinical use. Whereas MSCs from own tissue sources require invasive surgeries or need time to culture from preserved raw tissues. While obtaining the umbilical cord tissue from discarded cord there is no pain involved in the procedure. Because these cells are less likely to produce immunological reactions than bone marrow cells, no HLA matching is required to be a match.

Reference
In fact, some experts say it contains nearly 10 times the amount of stem cells found in bone marrow. It is believed that stem cells found in cord have greater regenerative properties since they are younger than bone marrow.

Each vial of MesoCel contains a cell suspension of 100 million cells in 10 mL, corresponding to a concentration of 10 million cells/mL.

You must NOT be given MesoCel if you have acute hypersensitivity (history of anaphylactic reactions) to vancomycin , ofloxacin, and amphotericin B or these classes of compounds.

- Local anesthesia is not recommended due to the unknown effect of local anesthetics on the injected cells.

- As MesoCel is a living stem cell therapy it cannot be sterilized and, therefore, could contain potentially infected biological material although the risk is considered to be low and controlled in the manufacturing. If you experience any potential signs of infection after administration, please inform your physician immediately.

Data on the use of MesoCel in the elderly population are limited. However, given the cell-based nature of MesoCel and its local administration route, it is not expected that the benefit-risk profile of MesoCel in elderly patients will differ from that observed in non-elderly patients.

Data on the use of MesoCel in patients with hepatic or renal impairment are not available.

Do not administer this medicine in children up to 17 years as the safety and efficacy have not yet been established.

Do not administer this medicine in pregnant or lactating mothers as the safety and efficacy have not yet been established.

It is supplied as one treatment dose contained in 2 Aseptic Type I glass vials. Each vial contains 10 mL of MSC suspension and is closed with a rubber stopper and a flip-off seal. The vials are placed inside a cryo box.

The vial should be kept at below -150 °C in liquid nitrogen vapor at all times until its administration, to maintain the required temperature and should not be mixed with other medicinal products. Do not refrigerate or freeze or irradiate.

It is injected intravenously under the supervision of qualified healthcare personnel.

Currently no data is available on the side-effects of the MesoCel.

MesoCel has been approved for investigational use by Drug Controller General India (DCGI).

Yes, MesoCel should be thawed before patient administration.

No, the therapy can be undertaken without the need for immune matching between donor and patient

Store at below -150°C in the vapor phase of a liquid nitrogen freezer. The reconstituted product can be kept at room temperature and should be used within 2 hours from thaw

CTRI/2021/09/036645

MESOCEL is under investigational use for the treatment of COVID-19-induced acute respiratory distress syndrome (ARDS). ARDS is defined as an inflammatory lung injury that occurs due to fluid build-up in alveoli (air sacs) present in the lungs. In ARDS, lungs are not able to fill up air which eventually results in dangerously low oxygen levels in the blood, also known as hypoxemia which prevents vital organs such as the brain, heart, stomach, and kidney from receiving enough oxygen to function. The active ingredient of MesoCel is expanded human allogeneic mesenchymal adult stem cells extracted from umbilical cord tissue which promote epithelial and endothelial repair, alveolar fluid clearance, and bacterial clearance and exert anti-inflammatory and antiapoptotic effects in COVID-19 patients with pneumonia or COVID-induced ARDS.

References-

https://www.medicines.org.uk/emc/files/pil.9231.pdf
https://pdf.hres.ca/dpd_pm/00024994.PDF
https://www.sigmaaldrich.com/IN/en/technical-documents/technical-article/cell-culture-and-cell-culture-analysis/stem-cell-culture/mesenchymal-stem-cell-faq
LifeCell Package leaflet
https://www.dvcstem.com/post/what-are-mesenchymal-stem-cells
https://spectrumhealthmedical.com/education-resources/stem-cell-faq