Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01)



Status:Recruiting
Conditions:Other Indications, Cardiology, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology, Other
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:February 14, 2019
End Date:February 2020
Contact:Nick McCoy
Email:nmccoy@tissuetechinc.com
Phone:786-734-0023

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A Multicenter, Open Label Phase 2 Pilot Trial of Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01)

It is hypothesized that application at 4-week intervals of the human umbilical cord tissue
TTAX01 to the surface of a well debrided, nonhealing venous leg ulcer (VLU) will result in a
high proportion of wounds showing complete healing within 12 weeks of initiating therapy.
This open label pilot study provides a framework for a larger, controlled study. The purposes
for conducting this study are to evaluate the functionality of the protocol and to obtain an
estimate of product safety and efficacy when applied according to the protocol instructions,
and measured according to the stated endpoints.


Inclusion Criteria:

- Provide informed consent.

- Age ≥ 18 years and of either sex.

- Willing to comply with protocol instructions, including allowing all study
assessments.

- Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus),
with a surface area in the range of ≥ 2.0 cm2 and ≤ 18.0 cm2 confirmed using the wound
imaging and measurement device.

- Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular
or venous incompetence.

- Arterial supply adequacy confirmed by any one of the following: Great toe pressure ≥
50 mm/Hg; Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ to 0.8 to
≤ 1.1; TcPO2 ≥ to 40 mmHg from the foot

- Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon,
muscle, or bone

- Target ulcer duration ≥ 6 weeks but ≤ 104 weeks

- For diabetic subjects an HbA1C < 12.0% per the local lab report

Exclusion Criteria:

- Therapy with another investigational agent within thirty (30) days of Screening, or
during the study.

- A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis
lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).

- Deep Vein Thrombosis (DVT) that is acute, defined as the first 10 days from onset of
symptoms, or any DVT for which compression bandaging is considered by the Investigator
to be contraindicated.

- Clinical evidence of ulcer bed infection as described in the Study Guide.

- Documented history of osteomyelitis at the target wound location within 6 months
preceding the Screening Visit.

- Refusal of or inability to tolerate compression therapy.

- The subject is pregnant

- The subject is a nursing mother

- The subject is a woman of child-bearing potential who is unwilling to avoid pregnancy
or use an appropriate form of birth control (adequate birth control methods are
defined as: topical, oral, implantable, or injectable contraceptives; spermicide in
conjunction with a barrier such as a condom or diaphragm; IUD; or surgical
sterilization of partner).

- Therapy of the target ulcer with other birth tissue products, autologous skin graft,
Apligraf®, or Dermagraft® within 30 days preceding the Screening Visit.

- Therapy of the target ulcer with topical growth factors within 1 week preceding the
Screening Visit.

- Current therapy with systemic antibiotics.

- Current systemic therapy with cytotoxic drugs.

- Current therapy with chronic (> 10 days) oral corticosteroids.

- Current therapy with TNF alpha inhibitors other than Trental® (pentoxifylline).

- History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix
or adequately treated non-melanoma skin cancers).

- The subject has had previous use of NEOX® CORD 1K®, CLARIX® CORD 1K®, or TTAX01
applied to the index ulcer

- The subject has an allergy to Amphotericin B or glycerol

- The subject has an allergy to primary or secondary dressing materials used in this
trial

- Per Investigator's discretion the subject is not appropriate for inclusion in the
trial, e.g., undergoing surgical treatments or the subject currently has sepsis, i.e.,
life-threatening organ dysfunction caused by a dysregulated host response to infection
We found this trial at
6
sites
Las Vegas, Nevada 89119
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1111 Amsterdam Ave
New York, New York 10025
(212) 523-4000
St Luke's - Roosevelt Hospital Center With 523 beds, Mount Sinai St. Luke's serves as...
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New York, NY
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6114 Innovation Way
Carlsbad, California 92009
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Carlsbad, CA
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North Chicago, Illinois 60064
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North Chicago, IL
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Roanoke, Virginia
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Roanoke, VA
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Sylmar, California 91342
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Sylmar, CA
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