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

NCT03818828 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: TTAX01-CR002
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Venous Leg Ulcer

Keywords

venous stasis; VLU

Outcome Measures

Primary Outcomes (1)

• Complete wound healing

  Proportion of subjects who achieve complete wound closure over the 12-week treatment period from baseline with a 4 week followup to confirm wound healing.

  12-weeks

Secondary Outcomes (3)

• Time to complete wound healing

  up to 12 weeks

• Complete wound healing

  up to 12 weeks

• Changes in pain using the numeric rating scale

  up to 12 weeks

Other Outcomes (1)

• Sheffield Preference-based Venous Ulcer questionnaire (SPVU-5D) quality of life questionnaire

  up to 17 weeks

Study Arms (1)

TTAX01

EXPERIMENTAL

TTAX01 will be applied directly to the wound surface and fixed with sterile adhesive strips, plus a secondary foam dressing held in place by multi-layer compression bandaging. A single layer of the test article should cover the entire open surface of the wound. TTAX01 may overlap onto adjacent healthy tissue and must be fenestrated prior to or after fixture. The material is to be applied once every 4 weeks unless the wound shows evidence of healing, in which case product will be withheld; or, if the test article has been accidentally dislodged within 1-week post application, it may be replaced at the subsequent treatment visit.

Biological: TTAX01; Other: Profore Compression Therapy; Other: Cadexomer Iodine dressing

Interventions

TTAX01 BIOLOGICAL

TTAX01 is a cryopreserved human umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability. TTAX01 is manufactured by TissueTech Inc. utilizing a proprietary CRYOTEK® process, which devitalizes the living cells but retains the natural structural and biological characteristics relevant to this tissue. TTAX01 is aseptically processed in compliance with current Good Tissue Practices (cGTP). TTAX01 will be manufactured in various sizes, stored in a medium of Dulbecco's Modified Eagle Medium/Glycerol (1:1) containing Amphotericin B.

TTAX01

Profore Compression Therapy OTHER

Subjects will utilize the compression system for the duration of the trial, with weekly re-applications of the compression system during study visits

TTAX01

Cadexomer Iodine dressing OTHER

During the 2-week Screening Run-in period, subjects should be applied cadexomer iodine on the VLU.

TTAX01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• BioTissue Holdings, Inc: lead

Study Sites (6)

ILD Consulting, Inc.

Carlsbad, California, 92009, United States

Location

UCLA Olive View

Sylmar, California, 91342, United States

Location

Rosalind Franklin University

North Chicago, Illinois, 60064, United States

Location

Advanced Foot & Ankle Center

Las Vegas, Nevada, 89119, United States

Location

St Luke's-Roosevelt Hospital Center

New York, New York, 10025, United States

Location

Carilion Clinic

Roanoke, Virginia, 24013, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Scheffer Tseng, MD, PhD

  Chief Technology Officer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 28, 2019
• Study Start: February 14, 2019
• Primary Completion: December 20, 2019
• Study Completion: January 28, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)