Cell-Amniosin™

Cell-Amniosin

 

Description

 Cell-Amniosin™ is a IR.Iran-FDA approved product and its production line is GMP approved by the IR. Iran Ministry of Health.

Cell-Amniosin™ is a cryopreserved cellular human amniotic membrane-derived biological dressing. Human placental membranes are a rich source of MSCs, collagen matrix, and growth factors and also they contain different bioactive factors such as Fibronectin, Laminin, Proteoglycan and glycosaminoglycan, therefore they can support tissue regeneration and repair

Cell-Amniosin™ is supplied frozen in a clear bag containing one piece of 2×2, 3×3, 5×5, 5×10 or 10×10 cm for a single-use application. The product is stored at -80 ̊C ± 5 ̊C and is delivered to the customers in shipping containers packed with dry ice.

Cell-Amniosin™ assists in the restoration of the dermal bed, allowing wounds to heal.

Mode of action

Cell-Amniosin™ is manufactured from human placenta membrane. Cell-Amniosin™ has been demonstrated in clinical trials to improve the healing of diabetic foot ulcers. Cell-Amniosin™ has been shown to provide four elements to the chronic wound repair process:

  1. Supply living, nonsenescent fibroblasts that are capable of colonizing the wound bed and persisting.
  2. Provides fibroblast-derived cytokines, particularly angiogenic growth factors.

  1. Function as a permissive, performed, normal human matrix for keratinocyte migration.

  1. Release cytokines capable of reducing chronic wound inflammation.

When the product is applied to the wound surface, fibroblast factors and structural proteins such as collagen and other matrix components support the migration of the host cells into the wound cavity. Cell-Amniosin™ stimulates the wound repair process by providing metabolically active fibroblast, which remain viable in the wound for prolonged periods of time and continue to express growth factors and deposit matrix proteins necessary to promote vascularization and re-epithelialization.

The angiogenic effect of Cell-Amniosin™, which may be mediated by the secretion of VEGF by the product, is an important mechanism by which wound healing is accelerated.

Indications and Clinical use

Cell-Amniosin™ is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than 6 weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Cell-Amniosin™ should be used in conjunction with standard wound care regimens and in patients who have adequate blood supply to the involved foot.

Cell-Amniosin™ when implanted in adequately prepared diabetic foot ulcers assists in the restoration of the dermal bed allowing the patient to heal.

Contraindications

The presence of active infection or the ulcer extended to the tendon, muscle, joint capsule, or bone exposure

Precautions

Do not reuse, refreeze, or sterilize the product or its container.

Do not use the product if there is evidence of container damage or if the date and time stamped on the shipping box have expired.

The product must remain frozen at -80 ̊C ± 5 ̊C continuously until ready for use.

 

 

Adverse events

In clinical studies conducted to date, the overall incidence of reported adverse events was approximately the same for patients who received Cell-Amniosin™ compared to those who received the control treatment. To date, no immunologic reactions to Cell-Amniosin™ have been reported.

Dosage and administration

For the treatment of diabetic foot ulcers, the recommended treatment regimen is one piece of Cell-Amniosin™ implanted weekly, until the ulcer is healed. In a large multicenter controlled study, up to 8 applications of Cell-Amniosin™ were used. The one-time or less than weekly dosing of Cell-Amniosin™ has not been evaluated.

Directions for use

Before using Cell-Amniosin™, read full DIRECTIONS FOR USE.

The ulcer must be surgically (sharply) debrided: removing any necrotic or hyperkeratinized tissue, leaving a wound bed that meets the clinical criteria for skin grafting prior to application of Cell-Amniosin™. If extensive bleeding is observed, the bleeding must be stopped before applying Cell-Amniosin™.

After the initial application of Cell-Amniosin™, additional wound preparation should be limited so as to avoid disruption or removal of previously implanted Cell-Amniosin™.

Cell-Amniosin™ should not be used if infection is present in the wound. Clinical treatment should be initiated to resolve the infection. Once infection has cleared, treatment with Cell-Amniosin™ can be initiated or resumed.

Materials required for preparation and application:

  • Sterilized scissors
  • Surgical gloves (without of latex)
  • Sterile normal saline (0.9% sodium chloride) at room temperature
  • Sterilized forceps
  • Dressing supplies

 

IMPORTANT: Product must remain frozen at -80 ̊C ± 5 ̊C until ready to thaw. Do not reuse, refreeze, or sterilize this product or its container.

Following these directions is important to ensure delivery of metabolically active tissue to the patient’s wound.

Preparation for use:

  1. Remove the box containing Cell-Amniosin™ from either the freezer or the shipping box per the storage and transfer instructions found in the shipping box. Close the freezer door or the shipping box and then immediately begin the thawing process.
  2. Tear the cardboard open along perforation.
  3. Remove the foil pouch from the box
  4. Tear open the foil pouch with your hands at the tear notch. Do not cut with scissors.
  5. Remove the clear bag containing Cell-Amniosin™.do not open the clear bag.

NOTE: During the thawing and rinsing steps, do not touch areas of the bag that come in contact with Cell-Amniosin™.

  1. Put the clear bag in the room temperature. Allow approximately 2 minutes for thawing. The process is complete when there are no ice crystals visible.

 

NOTE: Do not thaw longer than 3 minutes. Do not thaw more than one piece of Cell-Amniosin™ in the same water bath at the same time.

 

  1. Handling by the outer edges.
  2. Put on surgical gloves and cut the bag open above the cut line with clean scissors.
  3. Gently squeeze the solid plastic bar to open the bag.

NOTE: Dispose of all liquid, rinsing solutions, and Cell-Amniosin™ components in accordance with institution or government environmental regulations.

 

Application:

NOTE: After draining the bag, implant Cell-Amniosin™ immediately to prevent tissue drying.

 

  1. Carefully peel the plastic from the Cell-Amniosin™ using sterilized forceps.
  2. Implant Cell-Amniosin™ into the debrided ulcer. Covering the surface of the wound to just below the epithelial layer.
  3. Cover the wound with a nonadherent dressing and if necessary enough saline-moistened gauze to fill but not pack the wound.
  4. Between routine applications of Cell-Amniosin™, it is important to maintain a moist wound environment.
  5. Following each application of Cell-Amniosin™, the first wound dressing change should take place in approximately 5 days.

NOTE: If a dressing change is needed prior to 5 days, the nonadherent dressing layer should be left in place. Do not remove previously implanted Cell-Amniosin™.

 

AVAILABILITY

Cell-Amniosin™ is supplied frozen in a clear bag containing one piece of approximately 2×2, 3×3, 5×5, 5×10 or 10×10 cm2 for a single-use application. The clear bag is enclosed in a foil pouch and labeled. Cell-Amniosin™ is manufactured with sterile components under aseptic conditions within the final package.

Storage recommendations

Testing was completed to support the safe storage, shipping, and handling of Cell-Amniosin™ prior to application to the wound. Specifically, the testing demonstrated that the product and package integrity are maintained during freezing, storage, shipping and thawing.

Cell-Amniosin™ can be stored frozen for up to 2 years at -80 ̊C ± 10 ̊C and can be shipped to healthcare facilities without compromising product integrity or sterility. The shipping container should not be opened until the device is ready to be thawed for use or to transfer the device to a -80 ̊C ± 10 ̊C freezer. The insulated shipping container will contain dry ice (solid carbon dioxide). Exercise caution when opening the container.