photo of jar of AutoloGel and dressing kit packages
Natural healing from within.
photo of doctor holding chart and wearing stethoscope around neck

What is AutoloGel?

Skin ulcers and wounds that don’t heal can have a significant impact on quality of life.

If you are a health care professional, you know that treating and closing these stalled wounds is a challenge.

Try AutoloGel®— it works differently.

Derived from the patient’s own platelets, the body’s natural healing agents, AutoloGel kick-starts natural healing from deep within the wound bed.

  • Is the first platelet rich plasma (PRP) gel to be cleared by the FDA for treating chronic wounds
  • Can be used to treat exuding wounds such as leg ulcers, pressure ulcers, and diabetic ulcers
  • Helps manage mechanically and surgically-debrided wounds
  • Forms a natural fibrin matrix from the plasma that acts as a scaffold for new cells to adhere
  • Produces visible results in days, not weeks
  • Reduces overall cost of care and improves patients’ lives

If you are a patient, download our patient brochure for more details, and ask your doctor if AutoloGel is right for you.

Warning
Patients known to be sensitive to components and/or materials of bovine origin are contraindicated. See the instructions for use . AutoloGel is produced with the use of bovine thrombin.

How AutoloGel® Works

In a new wound, platelets are the first cells to arrive. They clot to stop the bleeding, and then they release substances (growth factors, cytokines, and chemokines) to kick-start the natural wound healing process. Wounds that are no longer healing may have stopped attracting platelets to the injured site.

AutoloGel Works Differently

Most treatments just cover a wound and are rarely effective deep within the wound bed where healing has stalled. AutoloGel is a unique, flowable gel made of the patient’s own platelets that molds to the size and shape of any wound. This stimulates the formation of tissue to fill in wound defects and helps reduce wound volume.

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Treatment Process

graphic of a clock

AutoloGel is simple and quick to prepare and apply, and can be administered right in the physician’s office or outpatient clinic.

graphic of a test tube

The clinician takes a small amount of the patient’s blood and uses the AutoloGel System centrifuge to separate the platelets.

graphic of a flask

The platelets are then mixed with additives, such as ascorbic acid, to produce a gel that is applied over the entire wound and covered with a clear dressing.

Simple AutoloGel Processing and Application

After drawing the patient’s blood, the processing and application of AutoloGel® takes about 5 minutes *.

* Not including drawing blood.

For more detailed information about how to use AutoloGel, download the instructions for use PDF .

Warning
Patients known to be sensitive to components and/or materials of bovine origin are contraindicated. See the instructions for use . AutoloGel is produced with the use of bovine thrombin.

Return to Treatment Process.

Results

Visible Results in Days, Not Weeks

graph of average wound age with and without AutoloGel
  • Average age of wounds prior to PRP gel treatment was 337 days.
  • 91% of long-term stalled wounds responded to AutoloGel® treatment with a 64% reduction in volume in 15 days or less.

Example of Chronic Pressure Ulcer

Significantly More Wounds Closed with AutoloGel

graph of percentage of wounds closed with and without AutoloGel
  • In a diabetic foot ulcer randomized controlled study††, 81.3% of wounds less than 7cm2 treated with AutoloGel® healed completely in 6.2 weeks, vs. saline gel.

Effective in Grade I and II Diabetic Foot Ulcers

graph of various diabetic foot ulcer therapy healing rates
  • Published Outcomes from Diabetic Foot Ulcer Prospective Trials

For more detailed information about how to use AutoloGel, download the instructions for use PDF .

If you are a physician, see more information from AutoloGel clinical case studies.

Footnotes

Study:

  1. de Leon JM, Driver VR, Fylling CP, et al. The clinical relevance of treating chronic wounds with an enhanced near-physiological concentration of platelet-rich plasma gel. Advanaced Skin Wound Care. 2011;24(8):357–368.

†† Study:

  1. Driver VR, Hanft J, Fylling CP, Beriou JM; AutoloGel Diabetic Foot Ulcer Study Group. A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers. Ostomy Wound Management. 2006;52(6):68–87.

††† Multiple Studies:

  1. Driver VR et al. Ostomy Wound Management. 2006;52(6):68–87.
  2. Osiris FORM 10-Q for the quarterly period ended September 30, 2013.
  3. Veves A et al. Diabetes Care, 24(2):290–295, 2001.
  4. Steed DL et al. Journal of Vascular Surgery 21(1); 1995.
  5. Marston WA et al. Diabetes Care, 26: 1701–1705, 2003.

AutoloGel Clinical Case Studies

Case 1

BKA Dehiscence with Sinus Tract

Patient History

  • 46 year-old male presented with S/P BKA, with subsequent incisional dehiscence
  • Patient had been hospitalized for 9 of 10 weeks and the wound was showing signs of regression
  • Medical History included diabetes and renal failure
  • Previous Treatments included VAC
  • Patient received 3 AutoloGel® PRP Gel treatments over 10 days

Outcomes

  • Sinus Tract Healed
  • Area Reduced 53.3%
  • Volume Reduced 95.3%
  • Engineered matrix grafted for final closure

Core Wound Measurements

graph of core wound measurements

Underlying Measurements

graph of underlying measurements

Case 2

Extensive Exposed Fascia and Tendon

Patient History

  • 89 year-old female presented with a full thickness left anterior tibial ulcer, with exposed fascia, tendon, and muscle
  • Medical History included diabetes
  • Goal of treatment was to prepare the wound for grafting
  • Patient received 1 AutoloGel PRP Gel treatment

Outcomes

  • Volume was reduced 59.2% by Day 7
  • Wound showed extensive granulation tissue growth covering the majority of fascia, tendon & muscle by Day 11, and was ready for grafting

Core Wound Measurements

graph of core wound measurements

Case 3

Surgical Incision

Patient History

  • 38 year-old male presented with S/P surgical incision for an abscess
  • Medical History showed patient was obese
  • After initial treatment with NPWT for 6 days.
    • Area reduced 16.7%
    • Volume reduced 35.9%
    • Depth reduced 1.2 cm
  • Dressing changes proved difficult due to patient weight and size of incision
  • Patient received one AutoloGel PRP Gel treatment on Day 6

Outcomes

  • 4 Days after AutoloGel PRP Treatment
    • Area reduced by 42.9%
    • Volume reduced by 78.6%
    • Depth reduced 2.5 cm

Core Wound Measurements

graph of core wound measurements

AutoloGel Publications

If you wish to review these studies in greater detail, select the reference title below or download the body of evidence references PDF .

  1. Driver, V. R., Hanft, J., Fylling, C. P., Beriou, J. M., & AutoloGel Diabetic Foot Ulcer Study Group. (2006). A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers. Ostomy Wound Management, 52(6), 68–87.
  1. Carter, M., Fylling, C., Li, W., De Leon, J., Driver, V., Serena, T., et al. (2011). A statistical analysis of a wound outcomes registry using run-in data: clinical impact of platelet rich plasma gel on healing trajectory. Intl. Wound Journal 2011; 8:638–650.
  2. Sakata J, Sasaki S, Handa K, Uchino T, Sasaki T, Higashita R, Tsuno N, Hiyoshi T, Imakado S, Morimoto S, Rinoie C, Saito N. A retrospective, longitudinal study to evaluate healing lower extremity wounds in patients with diabetes mellitus and ischemia using standard protocols of care and platelet-rich plasma gel in a Japanese wound care program. Ostomy Wound Management 2012;58(4):36–49.
  1. Frykberg, R. G., Driver, V. R., Carman, D., Lucero, B., Borris-Hale, C., Fylling, C. P., et al. (2010). Chronic wounds treated with a physiologically relevant concentration of platelet-rich plasma gel: a prospective case series. Ostomy Wound Management, 56(6), 36–44.
  2. Rappl LM. (2011) Effect of platelet rich plasma gel in a physiologically relevant platelet concentration on wounds in persons with spinal cord injury. Intl. Wound Journal, 8(2), 187–195.
  3. de Leon J, Driver VR, Fylling CP, Carter MJ, Anderson C, Wilson J, et al. (2011) The clinical relevance of treating chronic wounds with an enhanced near-physiological concentration of platelet rich plasma (PRP) gel. Advances in Skin and Wound Care, 24(8), 357–368.
  1. Gurvich, L. (2009). Synergism in using negative pressure wound therapy with alternated applications of autologous platelet-derived growth factors in treating post-acute surgical wounds. Wounds – A Compendium Clin. Res. Pract., 21(5), 134–140.
  1. Dougherty EJ. (2008) An evidence-based model comparing the cost-effectiveness of platelet-rich plasma gel to alternative therapies for patients with nonhealing diabetic foot ulcers. Advances in Skin Wound Care, 21(12):568–75
  1. Carter, MJ, Fylling, CP, Parnell, LKS. (2011) Use of Platelet Rich Plasma Gel on Wound Healing: A Systematic Review and Meta-Analysis. www.eplasty.com, Open Access Journal of the Journal of Plastic Surgery. September 15, 2011.

For more detailed information about how to use AutoloGel, download the instructions for use PDF .

Return to Results.

Coverage

Medicare reimburses for AutoloGel when physicians agree to collect their patients’ treatment data for Medicare. This is called Coverage with Evidence Development (CED). CED is a program that Medicare uses to provide coverage†† for items or services while building additional evidence about how patients benefit from these products. It also provides qualified patients with access to an innovative and effective Wound Management therapy.

As part of this data collection program, the following types of wounds are covered:

  • Diabetic foot ulcers
  • Venous ulcers
  • Pressure ulcers
For more details on billing and reimbursement codes related to AutoloGel and the CED program please see Reimbursement Guide for Hospitals and Reimbursement Guide for Physician Offices . †† For more information on indications and limitations of coverage, see the Centers for Medicare & Medicaid Services (CMS) analysis of National Coverage Determination (NCD) for Blood-Derived Products for Chronic Non-Healing Wounds.

Participation Information for Physician & Healthcare Professionals

If you are a health care professional, a representative from Cytomedix, the manufacturer of AutoloGel, can explain the data collection protocols and will support you from initial enrollment through treatment, documentation, and claims submission. Please Contact Us for more information on the CED protocol and Medicare reporting requirements .

Coverage under private insurance and Medicaid is currently determined on a case-by-case basis.

For more detailed information about how to use AutoloGel, download the instructions for use PDF .

Learn about Medicare reporting requirements

Medicare Reporting Requirements

Clinicians participating in patient data collection must adhere to the following reporting requirements. To learn how to become involved, visit the AutoloGel Medicare Patient Access Program page.

Cohort Data Collection Protocol for Venous Leg Ulcers (VLUs)

Primary Objective

Compare complete healing in subjects treated with AutoloGel + Usual and Customary Care (UCC) versus UCC only.

Primary Endpoint

Time to complete closure within a
 12-week treatment window.

Key Inclusion Criteria

  1. Proven venous disease
  2. Venous leg ulcer located between the knee and ankle
  3. Initial (debrided)
 VLU area 2–200 cm2
  4. Ulcer wound duration ≥ 1 month
  5. Age ≥ 18 years
  6. Patient enrolled in Medicare
  7. Demonstrated adequate compression regimen

Secondary Endpoints

  1. Proportion of healed VLU at 12 weeks
  2. Change in W-QOL (Quality of Life with Chronic Wounds) mean score between baseline and 12 weeks
  3. Decrease in wound area from baseline to 12 weeks
  4. Ulcer recurrence at 1 year

Key Exclusion Criteria

  1. Allergy to bovine sourced products
  2. On chemotherapy
  3. Malignancy in wound area

Cohort Data Collection Protocol for Pressure Ulcers (PUs)

Primary Objective

Compare complete healing in subjects treated with AutoloGel + Usual and Customary Care (UCC) versus UCC only.

Primary Endpoint

Time to complete closure within a
 16-week treatment window.

Key Inclusion Criteria

  1. Ulcer of pressure/shear etiology (Stage II–IV)
  2. PU located on the heel, ischium, sacrum, and trochanter
  3. Initial (debrided) PU area
 3–200 cm2
  4. Ulcer wound duration ≥ 1 month at first visit
  5. Age ≥ 18 years
  6. Patient enrolled in Medicare
  7. Demonstrated adequate
 offloading regimen

Secondary Endpoints

  1. Proportion of healed PU at 16 weeks
  2. Change in W-QOL (Quality of Life with Chronic Wounds) mean score between baseline and 16 weeks
  3. Decrease in wound area from baseline to 16 weeks
  4. Ulcer recurrence at 1 year

Key Exclusion Criteria

  1. Stage I ulcers
  2. Ulcers that are unstageable or of deep tissue injury morphology but have yet to become an open wound
  3. Allergy to bovine sourced products
  4. On chemotherapy
  5. Malignancy in wound area

Cohort Data Collection Protocol for Diabetic Foot Ulcers (DFUs)

Primary Objective

Compare complete healing in subjects treated with AutoloGel + Usual and Customary Care (UCC) versus UCC only.

Primary Endpoint

Time to complete closure within a 12-week treatment window.

Key Inclusion Criteria

  1. Patient enrolled in Medicare
  2. Age ≥ 18 years
  3. Type I, II diabetes requiring medical treatment
  4. Largest non-healing or single index wound is Wagner 1–5 DFU and located on the dorsal, plantar, medial, or lateral aspect of the foot or heel
  5. Debrided ulcer size 0.5 cm2 to 50 cm2
  6. Demonstrated adequate offloading regimen
  7. Ulcer wound duration ≥ 1 month
 at first visit

Secondary Endpoints

  1. Proportion of completely healed DFUs at 12 weeks
  2. Change in W-QOL (Quality of Life with Chronic Wounds) mean score
  3. Ulcer recurrence
  4. Incidence of amputation at one year

Key Exclusion Criteria

  1. Concurrent treatment of another wound that may interfere with AutoloGel treatment
  2. Ulcer not a DFU
  3. Malignancy other than non-melanoma skin cancer
  4. Inadequate venous access to draw blood for treatments

AutoloGel® Randomized Controlled Trial in Wagner 1 & 2 Diabetic Foot Ulcers (DFUs)

Primary Objective

To demonstrate the efficacy of complete wound healing in a prospective, single-blind, randomized controlled trial in which Wagner 1 or 2 DFUs will be treated with AutoloGel using usual and customary care (UCC), or just UCC.

Primary Endpoint

Compare time to heal in Wagner 1 and 2 Diabetic Foot ulcers within a 12-week treatment window.

Key Inclusion Criteria

  1. Type I or II diabetes requiring medical treatment as determined by the physician
  2. The largest non-healing wound is a Wagner 1 or 2 DFU that is located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces but not on the heel)
  3. Debrided ulcer with an area measured as being greater than or equal 0.5 cm2 and less than or equal to 20 cm2
  4. Demonstrated adequate offloading regimen
  5. Ulcer wound duration ≥ 1 month at first visit
  6. Patient enrolled in Medicare
  7. Age ≥ 18 years

Secondary Endpoints

  1. Assess the wound healing trajectory
  2. Change in the Chronic Wound Quality of Life (W-QOL) mean score between baseline and 12 weeks
  3. Assess comparative safety of AutoloGel and UCC
  4. Correlation to wound healing and changes in the W-QOL will be obtained

Key Exclusion Criteria

  1. Allergy to bovine sourced products
  2. On chemotherapy
  3. Malignancy in wound area

For more detailed clinical information about how to use AutoloGel, download the instructions for use PDF .

Return to Coverage.

Contact Us

AutoloGel® is produced and distributed by Cytomedix, a leading commercial developer of regenerative therapies derived from, and delivered to the same patient. For more clinical or patient information about AutoloGel please complete and submit the following form:

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