A new frontier in
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What is OrthoMatriX™
OrthoMatriX™ is a Wharton’s jelly allograft product regulated under section 361 of the Public Health Service Act (PHS) and 21 CFR Part 1271.
OrthoMatriX™ is processed to preserve the structural integrity and original relevant characteristics of Wharton’s jelly as observed in the donor and is intended for homologous use only.
What is
Wharton's Jelly?
The Wharton’s jelly matrix is the unique, gelatinous, and cell-rich connective tissue found within the umbilical cord that primarily serves to protect the umbilical blood vessels from compression and torsion by providing protection, cushioning, and structural support.
The Wharton’s jelly comprising OrthoMatriX™ is minimally-manipulated to preserve the structural integrity and original characteristics of the connective tissue relating to its utility to supplement missing or damaged tissue in the recipient.
Umbilical Cords (UCs) are ethically donated by healthy, consenting mothers after full-term, healthy deliveries. OrthoMatriX™ does not contain any material obtained from an embryo or fetus.
Composition
& Structure
The matrix is composed mainly of an extracellular matrix (ECM) and fibroblast-like stromal cells (myofibroblasts).
Key components include:
Collagen fibers: Primarily types I, III, V, and VI, which provide structural integrity.
Ground substance: Rich in glycosaminoglycans (GAGs), with hyaluronic acid making up nearly 70% of the total GAG content. Other GAGs include chondroitin sulfates and heparan sulfate.
Growth factors: Contains various growth factors such as vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF), and transforming growth factor-beta (TGF-β), which are crucial for cellular processes and tissue regeneration.
Mesenchymal Stem Cells (MSCs), along with other stromal cells like myofibroblasts, fibroblasts, and some mast cells, all embedded in a gelatinous matrix rich in hyaluronic acid and collagen that protects the cord’s blood vessels.
The matrix lacks blood or lymph vessels and nerves, making it an immunologically privileged site.
Orthopedic Application
Aging and injury decreases structural factors such as collagen and elastin leading to a degradation of structural morphology. OrthoMatriX™ is a structural connective tissue allograft intended for homologous use to replace or supplement missing or damaged tissue directly at the site of a structural defect. Wharton’s jelly is processed to preserve the structural integrity and original characteristics of the connective tissue relating to its utility to supplement missing or damaged tissue in the recipient.
The Natural Alternative to Serial Steroid Use
OrthoMatriX™ may be preferable to repeated cortisone injections primarily due to the differing long-term side effect profiles. Cortisone injections, when administered multiple times, carry risks such as cartilage damage, tendon weakening or rupture, localized fat atrophy, and potential systemic side effects.
OrthoMatriX™ is used as replacement tissue suited for orthopedic applications where volume is needed to cushion or support the affected area and as a natural healing mechanisms to repair tissue, potentially offering more durable results with fewer risks of structural degradation to the joint with a potentially safer long-term side effect profile than serial steroid use.
A Minimally-Invasive Option
OrthoMatriX™ is a promising non-surgical alternative that may help delay or avoid hip replacement surgery by addressing the underlying cause of pain, not just managing symptoms. Injected into the affected joint, it provides high concentrations of mesenchymal stem cells, growth factors, and hyaluronic acid which work to reduce inflammation, provide cushioning, and encourage the body’s natural tissue repair processes. This minimally invasive, outpatient procedure allows patients to return to normal activities quickly with few side effects, offering the potential for long-term pain relief and improved mobility without the risks and extensive recovery time associated with major surgery.
Administration
OrthoMatriX™ allografts consist of donated human umbilical cord tissue that has been disassociated, suspended in saline, and cryopreserved.
DOSE:
OrthoMatriX™: 75mg tissue per mL
OrthoMatriX™: 50mg tissue per mL
OrthoMatriX™: 25mg tissue per mL
Complete Solution
Item Model Number: DW-86W25
Capacity: 25 L / 0.88 ft³
Temperature Range: -40°F – 123°F / -40°C – 86°C
Voltage: AC110 – 120 V
Frequency: 60 Hz
Wattage: 230 W
Type of Alarm: Sound – Light Alarm
Inner Material: 304 Stainless Steel
Temperature Display: Digital Temperature Display
Product Weight: 63.93 lbs / 29 kg
Product Dimensions: 26.4 × 15.4 × 18.9 in / 670 × 390 × 480 mm
Inner Dimensions: 11.81 × 9.84 × 11.81 in / 300 × 250 × 300 mm
Noise: ≤55 dB
Q1: What is the ultra-low temperature of this freezer?
A1: This lab-grade ultra-low temperature freezer is specifically designed to reach a minimum temperature of -123°F, ensuring extreme cold storage for your samples.
Q2: How precise is the temperature display of this freezer?
A2: The freezer features a precise temperature control system with an accuracy of ±0.1°C in temperature display, ensuring reliable and stable conditions for your storage needs.
Q3: What are the internal and external dimensions? Can you specify the storage capacity?
A3: The internal dimensions are 11.81″ × 9.84″ × 11.81″, the external dimensions are 26.4″ × 15.4″ × 18.9″, and the storage capacity is 25 L. These clear specifications help you confirm its compatibility with your space.
Compliance
All biologics are manufactured in TriCelX’s United States Food and Drug Administration (FDA) registered, ISO Level 7 (FED 209E class 10,000 classification) cleanroom and FDA compliant cell processing facility at The Baylor Scott & White Sports Therapy and Research Center at The Star in Frisco, Texas in stringent compliance with all FDA rules (cGPT and cGMP) ensuring the safety, identity, fidelity, potency and purity of TriCelX’s biologics.
Because Jelly products satisfy both “minimal manipulation” and “homologous use” requirements of Section 361, regulated solely under section 361 of the PHSA, 42 U.S.C.§ 264.
TriCelX™ does not use any material obtained directly from the embryo or fetus and is processed from human umbilical cord tissue, donated following full term deliveries, in accordance with all applicable FDA rules and regulations.
Selected Scientific References
- Wharton’s jelly and osteoarthritis of the knee, https://pmc.ncbi.nlm.nih.gov/articles/PMC10993459/
The present published evidence suggests that WJ tissue and associated MSCs are encouraging for the management of knee OA.
- Safety and Efficacy of Wharton’s Jelly Connective Tissue Allograft for Rotator Cuff Tears: Findings from a Retrospective Observational Study, https://pmc.ncbi.nlm.nih.gov/articles/PMC11048385/
The application of Wharton’s jelly allografts in this retrospective cohort was observed to promote decreases in patient-reported NPRS scores, pain, and stiffness in the shoulder and improve function. These improvements were consistent across age groups but were most notable for the elderly population, who generally have a slower and less effective recovery rate after conservative treatment and surgical procedures.
- Retrospective Evaluation of Cryopreserved Human Umbilical Cord Tissue Allografts in the Supplementation of Cartilage Defects Associated with Hip Osteoarthritis, https://www.mdpi.com/2077-0383/13/14/4040
WJ allografts have been shown to significantly improve self-reported pain scores of patients with degenerated cartilage from hip osteoarthritis. Provided there have been no reported adverse reactions related to the tissue allografts within the span of the retrospective repositories beginning, WJ allografts should be considered as a safe regenerative medicine option for individuals suffering from tissue degeneration refractory to other standard-of-care methods.
A global translational leader in evidence-based biologics. Led by renowned scientists and surgeons, TriCelX translates cutting-edge science into evidence based personalized solutions. With locations in Texas, Utah, and Antiqua, TriCelX offers patients globally harmonized cell therapy options.
TriCelX Inc.
Baylor Scott & White Sports Medicine
& Performance Facility
3800 Gaylord Parkway, Ste. 1170
Frisco, TX 75034
kathryn@tricelx.com
855.874.2359
www.tricelx.com
