Indications for Use
The AutoloGel™ System is intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient’s own blood. Under the supervision of a healthcare professional, the PRP gel produced by the AutoloGel™ System is suitable for exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and for the management of mechanically or surgically-debrided wounds.

Dosing
The AutoloGel™ System may be used for chronic or surgically-debrided wounds up to twice a week for eight (8) weeks. The treating health care practitioner may elect to continue the treatment up to twelve (12) weeks. The AutoloGel™ System should be used in conjunction with standard of care procedures for comprehensive wound management1, such as:
  • Removal of necrotic or infected tissue
  • Off-loading
  • Compression therapy for venous stasis ulcers
  • Establishment of adequate blood circulation
  • Maintenance of a moist wound environment
  • Management of wound infection
  • Wound cleansing
  • Nutritional support, including blood glucose control for subjects with diabetic ulcers
  • Bowel and bladder care for subjects with pressure ulcers at risk for contamination
  • Management of underlying disease

Contraindications
AutoloGel™ is contraindicated in the following patients or wounds :

  • Patients known to be sensitive to components and/or materials of bovine origin
  • Patients on chemotherapeutic agents
  • Patients with the following abnormal laboratory test levels
    ● hemoglobin <10.5 g/dL
    ● platelet count <100 x 109/L
    ● serum albumin level < 2.5 g/dL
  • Wounds due to malignancy
  • Wounds with active clinically diagnosed infection2

Description
The AutoloGel™ System includes:

- AutoloGel™ Centrifuge II leased from Cytomedix
- AutoloGel™ System Wound Dressing Kit
- AutoloGel™ System Reagent Kit
- A single application license to use the patented PRP gel process

The AutoloGel System Wound Dressing Kit contains single-use, disposable components for performing a patient phlebotomy, centrifuging blood to derive PRP and activating and applying the AutoloGel. The AutoloGel System reagent kit contains components such as thrombin that activates platelets and ascorbic acid which may scavenge free radicals and inhibit damaging proteases. The reagent kits are sold separately and can support up to 5 applications. Our small, quiet portable centrifuge has a 60 second spin cycle to produce the PRP Gel efficiently at the point-of-care. The disposable kit components eliminate shelf-life and transportation issues and the need for complicated scheduling with external PRP Gel Service providers. The small-volume blood draw, ease of operation & portability make the AutoloGel System ideal for all types of clinical care settings.

License
Each time you use any autologous platelet rich plasma gel including the Autologel System, you require a single application use license from Cytomedix. Patent infringements are actively investigated.

1 Diegelmann R, Evans MC. Wound Healing: An Overview of Acute, Fibrotic and Delayed Healing. 2004. Frontiers in Bioscience 9:283-289
2 Sharman D. Moist wound healing: a review of evidence, application and outcome – Review, 2003 The Diabetic Foot, Autumn
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