JoinTechlabs Inc.

Mini-Stem™ System - US and Foreign Patent Pending

Stem cells classification

Stem cells are the source of regenerative capacity of human body. They possess two unique properties:

  • Self-renewal
  • Pluri- , poly- or toti- differential potency, which means the ability to differentiate into various types of tissue.

Moreover, these cells are in fact mini-factory of biological active factors, which could stimulate and support tissue regeneration.
Three main types of stem cells are:

  • Embryonic stem cells – obtained from leftovers of in vitro created embryos (IVF);
  • Adult stem cells – naturally present in most of human tissues, in particular, at young and middle age;
  • Induced pluripotent stem cells - artificially created from somatic cells by gene manipulation.

While embryonic stem cells are, in effect, the blank slate upon which all of the tissues, organs and structure of the human body is drawn, the adult stem cell has a different, though related, overall function. It is a repair cell. Sitting quiescently in bone marrow, tooth enamel, adipose (fat) tissues and other places in the body, these cells “wake up” upon receiving signals related to injury— inflammation.
So, when the human body is injured, the adult stem cells “wake up”, move through the body to the site of the injury, express proteins to down regulate inflammation, express other proteins to stimulate new cellular growth, recruit new growth factor proteins and then, themselves, begin to change into the very cells that have been damaged.
Adult stem cells are called mesenchymal stem cells (MSC), since its origin is in mesenchymal layer during prenatal development.
Adipose tissue is an abundant source of MCS. Recently, adipose-derived mesenchymal stem cells (ADMSC) based applications have attracted interest of multiple academic and commercial groups.

Use of adult stem cells today

The most common current therapeutic use of stem cells by physicians and veterinarians is their harvesting from one part of the body, where they exist in greater amounts and re-implantation at the site of injury, where they are most needed but are in short supply. With this doctors can address different medical conditions – from inflammation to various types of tissue regeneration.

Problems for patients

Currently, patients who are looking to acquire cell therapies are facing 3 major issues:

  • High cost of therapies. This is driven by therapies’ availability within only limited number of specialized clinics.
  • No local availability of therapies. Patients need to travel to remote clinics’ locations.
  • Absence of therapy’s transparency. Patients don’t have clear understandings of clinics credibility, qualification of personnel and quality of used cells and materials.   

Mini-Stem™ addresses these issues, by lowering the cost of therapies, making them available locally and assuring quality by providing doctors with the controlled process of cell extraction.

Problems for Doctors

Cell based therapies need to reflect ethical and clinical requirements of good practice. Therefore, the entire process of cell extraction and applications must comply with regulations.
Slow adoption rate of cell therapies is driven by small-to-medium size doctor’s practices inability to get access to optimized stem cell technology. To offer cell therapies doctors need the following:

  • Knowledge of stem cells harvesting process;
  • Well-equipped Labs;
  • Clean room environment;
  • Regulatory approval for:
    • Good laboratory practice (GLP);
    • Good manufacturing practice of clean room (GMP);
    • Valuable clinical data.

Above conditions do not allow for small-to-medium size doctors’ practices to enable cell therapies. It requires specific knowledge, time, and substantial financial investment, all of which create a hurdle for doctor’s daily practice.

Current options

  • Currently most doctors are utilizing primitive self-invented methods of cell extraction by fat sample collection and centrifugation. These methods create issues:
  • Potential exposure to contamination;
  • No assurance of cell fraction clarity or content;
  • Regulatory problems.
  • Recently few companies have starting to offer remote services for ADMSC processing. In this case the tissue sample is collected by a doctor, sent to remote Lab for cell processing and then returned back to the doctor’s office for application. This model creates issues:
  • Potential exposure to contamination as a result of unsecured transportation to and from the remote Lab facilities;
  • Time required for transportation and corresponding concerned quality;
  • Not in compliance with current FDA regulations;
  • High price tag.
  • Alternative offerings are structured around automation of cell extraction by cell processing units at patient’s bed. While been able to deliver high quality cell fractions, they are
  • Complicated to use;
  • Require trained personnel and maintenance;
  • Extremely expensive.

Ideal solution would allow doctors to gain access to high quality cell fractions without spending a lot on the process and infrastructure and would lead to the following:

  • Increase cell based therapies adoption by doctors;
  • Simplify access to therapies for patients;
  • Substantially drive cost of therapies down.

JointechLabs Mini-Stem™ System

Mini-Stem™ system is a closed disposable kit for human tissue processing and extraction of high quality Stromal Vascular Cell Fraction (SVF). Following our company’s collaboration with leading pharmaceutical companies, we have developed and optimized a laboratory protocol for adipose tissue, utilizing reagent of a new generation. This protocol provides access to a high quality cell fraction, making the final product safe and compliant with the most of FDA regulatory requirements.
We have developed the concept of totally innovative device, which contains the entire laboratory protocol inside of a closed, isolated from the surrounding environment system.

There are 2 addressable groups of users for Mini-Stem™ System – practicing physicians with clinical therapies and researchers with medical applications development.

Mini-Stem™ system allows for small physician practices as well as surgical centers to employ affordable methods for safe extraction of high quality SVF from various types of human tissue of a patient for clinical therapies or cryo-storage (banking). The entire procedure - from tissue extraction to processing and application into recipient is performed within the same facility, within 3-24 hrs. Thereby, the process would comply with FDA definition of “minimal manipulative” cells, allowing the exploration of cell applications as “innovative treatments” without costly multiphase clinical trials. Use of Mini-Stem™ system makes clinical therapies more safe and affordable for patients in comparison with the current improvised approaches.

With Mini-Stem™ researchers can realized the following benefits:

  1. Simplification of tissue manipulation for researchers by eliminating steps in the process;
  2. Creation of standardized work algorithm and elimination of sample contamination risk;
  3. Cost effective tool for translating stem cell research into clinical applications.

Mini-Stem™ is comprised of secure, sterile and closed system for collection of sample of adipose tissue amongst other types of tissue, its on-site processing and purification of cell fractions. The system requires availability of centrifuge and shaker (both can be supplied by JointechLabs), and operable by a trained lab technician. Human (adipose, for example) tissue processing occurs in a system that maintains a closed, sterile fluid/tissue pathway. This is achieved by the use of sterile containers and tubing, which allows for transfer of tissue and fluid elements within a closed pathway. A series of processing reagents (e.g., saline, enzymes, etc.) can be supplied by JointechLabs. This allows for simple control of the addition of reagents and timing of the processing, thus simplifying the manually controlled process.

Mini-Stem™ System Components

Mini-Stem™ system includes three principal components:

  • Permanent set of assisting equipment – thermo-shaker, proprietary centrifuge and cell counter (optional)
  • Single-use closed disposable kit
  • Processing solutions/reagents (optional)

The components are adapted for better cooperation with one another to facilitate collection and processing of human tissue, maintain sterility and simplify the entire cell extraction process.
The recommended protocol incorporated into the system, utilizes reagents of highest quality (GMP) and of non-animal origin. The key steps have been developed and tested in the lab, including temperature regiment, timing and concentrations of reagents. Enzymatic tissue digestion was adjusted to clinical level upon collaboration with Roche USA.

Mini-Stem™ System Disposable Kit Components

  • Processing unit (260 ml) – certified closed system, including incorporated filtration compartment;
  • 2 fine processing units of 50 ml – certified closed system;
  • Connectors -both units connected and disconnected in closed system manner;
  • Set of syringes:
    • Three syringes of 60 cc each;
    • Two syringe of 20 cc;
    • One syringe of 5 cc;
    • Six Luer lock caps

Mini-Stem™ Process Description

The process is initiated by collection of fat sample (100-150ml) into sterile large volume syringes. The first unit design allows for Luer lock connection and release of the lipoaspirate into the vessel. Additional inlets allow for introduction of washing and digestion solutions into the unit, utilizing valve lured lock tips. The process occurs in a closed system, thereby eliminating contact of material with outer environment. Next, the digested tissue is washed and filtered at the same time through 100u filter during centrifugation cycle into the vessel bottom. From there it can be collected and transferred in closed manner through connector into the second unit by applying light negative pressure, utilizing one of 20 cc syringes. The second and the optional third units are also equipped with valve inlets and intended for final wash and preparation of the cellular fraction for further culturing or application.

The process can be performed in an operating room, clinical lab, if available or any dedicated room adopted for aseptic procedures. The system could allow access to SVF even in rural conditions, if required (field hospitals, for example).

The Mini-Stem™ system can be used to generate a pharmaceutical composition which contains a therapeutically effective amount of cells, preferably in a substantially purified form, together with the suitable vehicle in the appropriate amount in, order to provide the form for proper administration to the patient.

The process requires three steps of centrifugation in centrifugal device, provided by JTL.

The entire process is performed in the completely closed format, eliminating any exposure to surrounding environment.

The process, including mini-liposuction, takes on average up to 2 hours. It could be performed by any medical or laboratory professional.

In terms of collecting data or records requirements, JTL will provide handy cell counter as part of the permanent equipment set up.

Described process is intended for office-based performed procedures (orthopaedics, cosmetics, dermatology, wound and burns healing, etc.).

Applications by IV injections are not recommended at this stage.

2nd generation of Mini-Stem™ system will provide the ability of cell fraction encapsulation for applications in surgery room and more invasive procedures.

Target Customer Segments

With its Mini-Stem™ System, JointechLabs currently targets 2 primary user segments – cell therapy clinical practices and cell therapies research.
Clinical segment includes small-to medium size doctors’ practices.  

  • Doctors practices
  • Ambulatory surgery centers
  • Hospitals
  • Clinics
  • Sport associations
  • Military stationary and filed hospitals
  • Veterinary Practices

Research segment includes academia and cell therapy R&D companies.

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