Prospective, Single-Center, Open-Label, Pilot Study Using Cryopreserved Umbilical Tissue Containing Viable Cells in the Treatment of Complex Acute and Chronic Wounds

Robert F. Mullins, MD; Zaheed Hassan, MD; Bounthavy Homsombath, MD; Shawn Fagan, MD; Beretta Craft-Coffman, PA-C; Joan Wilson, MSN, MHA, RN; John G. Rumbaugh, MD; Molly Saunders, BS; Alla Danilkovitch, PhD

Disclosures

Wounds. 2020;32(8):221-227. 

In This Article

Results

Patient Demographics and Wound Characteristics

A summary of patient demographics and wound characteristics is presented in Table 1. Ten patients with 12 complex wounds were enrolled in the study and received 1 vCUT application in the intent-to-treat (ITT) population. Eight patients were male and 2 were female, with an average age of 57 years. Of the 10 patients, 60% had diabetes mellitus (DM), 60% had hypertension (HTN), 40% had hyperlipidemia (HLD), 30% had coronary artery disease (CAD), 20% had venous insufficiency, and 10% had kidney disease. Of the 12 wounds, 4 were diabetic foot ulcers (DFUs), 2 were venous leg ulcers (VLUs), 3 were traumatic wounds, 2 were pressure wounds, and 1 was a surgical wound. The average wound area was 16.5 cm2 (range, 6.0 cm2– 40.0 cm2), with an average duration of 10 months (range, 1.3–37.9 months). Two patients did not complete all 4 weeks of the study, thus were excluded from the analyses. The remaining 8 patients with 10 wounds constituted the PP population.

Clinical and Safety Outcomes

Clinical outcomes are presented in Table 2. Of the 10 wounds analyzed in the PP population, 8 achieved 100% granulation in a median time of 13 days (mean, 17.5 days). The median percent area reduction (PAR) was 40.5, and the median percent volume reduction was 59.4 by the end of the 4 weeks of treatment. Three of the 10 wounds achieved complete closure. There were 3 AEs reported during the study: 1 fall, 1 event of cellulitis, and 1 event of fever. The cellulitis event was determined to be the only AE possibly related to the treatment. By the end of the study, all 3 AEs had been resolved. The following 2 cases are representative of the study cases.

Case 1

A 75-year-old female with a history of CAD, basal cell carcinoma, arthritis, myocardial infarction, and chronic back pain presented to the clinic with 3 traumatic wounds of 1.3 months duration from a fall. The 3 wounds measuring 13.5 cm2, 30 cm2, and 6 cm2 were located on the left ankle, right knee, and left leg, respectively Figure 1A, 1D, 1G). All wounds had previously been treated with a skin autograft that failed.

Figure 1.

Patient 1 left ankle wound at (A) week 1, (B) week 2, and (C) week 4 post-applications (closed); patient 1 right knee wound at (D) week 1, (E) week 2, and (F) week 4 post-application (closed); and patient 1 left leg wound at (G) week 1, (H) week 2 (closed), and (I) week 4 post-application.
Note: Baseline photos were not obtained for this patient.

Wounds were cleaned and debrided to remove any dead or necrotic tissue. The vCUT product then was applied to each of the wounds and secured using thin adhesive strips (Steri-Strips; 3M). The wounds then were dressed with a nonadherent dressing and secondary dressings. The patient was instructed to keep the dressings dry and intact and to elevate both extremities as often as possible. Per protocol, the patient was to return weekly to the outpatient clinic for 4 additional weeks.

Two weeks after the procedure, the patient experienced another fall, causing 2 new wounds on her right forearm. However, the left lower leg wound that originally measured 6 cm2 had completely closed (Figure 1H). The left ankle wound decreased in size by 93.5% (0.84 cm2; Figure 1B), while the right knee wound increased in size by 50.0% (45.0 cm2; Figure 1E). At this point, no additional therapies were added to the patient's treatment regimen for the lower extremity wounds. The patient missed the third week visit, so no measurements were obtained. By the end of the 4-week treatment period, all 3 wounds had achieved complete closure (Figure 1C, 1F, 1I).

Case 2

A 39-year-old male with a history of venous insufficiency and gallbladder surgery presented to the clinic with a VLU of the right leg measuring 40 cm2 of unknown duration (Figure 2A). The wound previously had been treated with SANTYL (Smith+Nephew).

Figure 2.

Patient 2 at (A) baseline, (B) week 1, (C) week 3, and (D) week 4 post-application.

After the wound was cleaned and debrided, vCUT was applied to the wound and secured with the thin adhesive strips. The wound was dressed with the primary nonadhesive dressing, EXU-DRY (Smith+Nephew) and secondary dressings. The patient was instructed to keep the dressing dry and intact. Per protocol, the patient was to return weekly to the outpatient clinic for an additional 4 weeks.

At 1-week postoperatively, the wound had decreased in size by 40% (24.0 cm2; Figure 2B). The patient returned to the clinic 3 days later as a result of a cellulitis AE; however, the wound had further decreased to 20.1 cm2. At 3-weeks postoperatively, the wound measured 16.0 cm2 and the cellulitis AE had resolved (Figure 2C). At the end of the 4 weeks of treatment, the wound measured 21.25 cm2, with an overall PAR of 47% (Figure 2D).

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