Allogeneic Microvascular Tissue for Soft Tissue Repair
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Solution Overview
Problem
Current methods for tendon repair, such as surgical interventions and autologous stem cell treatments, face challenges including high failure rates, inconvenience, cost, morbidity, and risks associated with autologous stem cell sourcing, and are unsuitable for soft-tissue repair.
Innovation Solution
A composition comprising minimally processed, allogeneic, uncultured microvascular tissue with less than 50% viable stem or progenitor cells, suitable for regeneration of tendons, ligaments, or skin, which can be administered allogeneically or xenogeneically, and is stable at room temperature for extended periods.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If autologous stem cell treatments are used for tendon repair, then tissue regeneration is improved, but the procedure requires two surgical procedures with associated pain, cost, and morbidity
Solution Approach 1:
The patent applies preliminary action by preparing allogeneic stem cell products in advance and storing them for future use. This eliminates the need for second surgical procedures to harvest autologous cells, as pre-prepared allogeneic cells can be directly implanted. The cells are harvested from donors, processed, and stored in a bank, making them readily available when needed for patient treatment.
Solution Approach 2:
The patent uses copying by creating allogeneic cell products that can serve multiple patients. Instead of harvesting cells from each patient individually, stem cells from donor tissue are processed and can be used to treat multiple recipients. This copies the beneficial regenerative effect across multiple patients without requiring repeated harvesting procedures.
2Reliability
If autologous stem cells are harvested and processed in a lab, then tissue regeneration is improved, but there are risks in shipping the tissue and delay in treatment
Solution Approach 1:
The patent eliminates treatment delay by performing cell harvesting, processing, and storage in advance. Allogeneic stem cells are prepared from donors and stored in a bank before patient need arises. This preliminary preparation removes the time-consuming steps of harvesting and shipping from the treatment timeline, allowing immediate implantation when a patient requires surgery.
Solution Approach 2:
The patent extracts the problematic steps of harvesting and shipping autologous cells from the treatment process. By using pre-prepared allogeneic cells stored in a bank, the patent removes the need for same-day cell harvesting, processing, and shipping logistics that cause delays and introduce contamination risks.
3Quantity of substance
If allogeneic bone marrow cells are used for soft tissue repair, then cell availability is improved, but the product is unsuitable for soft-tissue repair and requires special handling
Solution Approach 1:
The patent applies local quality by selecting and processing specific tissue types (adipose, microvascular, umbilical cord) that are inherently suited for soft tissue repair. Instead of using bone marrow cells designed for hard tissue, the patent uses cells from soft tissue sources that naturally possess properties appropriate for regenerating soft tissues like tendons, ligaments, and skin.
Solution Approach 2:
The patent changes the parameters of cell source selection from bone marrow (hard tissue) to adipose, microvascular, and umbilical cord tissues (soft tissue sources). This parameter change in tissue origin provides cells with properties better matched to soft tissue regeneration requirements, eliminating the unsuitability issue while maintaining allogeneic availability.
4Reliability
If viable stem cells are used for tissue repair, then regenerative capacity is improved, but the risk of viral contamination and rejection is increased
Solution Approach 1:
The patent uses disposable, single-use allogeneic cell products that are pre-tested and packaged. Each product is designed for one-time use in a specific patient, eliminating the need for long-term cell cultures that could accumulate viral contaminants. The cells are used immediately upon implantation and do not require long-term persistence in the patient.
Solution Approach 2:
The patent creates multiple copies of tested and validated allogeneic cell products that can be distributed to different patients. Each copy has already undergone viral screening and quality control during manufacturing, so individual patients receive pre-validated cells without exposure to the risks of viral contamination that would occur during individual harvesting and processing.
Data Source
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AI summary
Disclosed are products and methods for treating soft tissue injuries. The provided methods include the production of processed or cryopreserved microvascular tissue. Also provided are products and methods of using processed or cryopreserved microvascular tissue for the treatment of soft tissue injuries.