Clinical Study of PAL-222 Targeting Patients With Refractory Skin Ulcer

NCT07016438 | Recruiting DMC

• 1 other identifier: PAL-222-P3
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess safety and efficacy in patients with with Refractory skin ulcer no response to existing therapy. The main measures it aims to answer are:

• Investigation of adverse events
• Changes in clinical testing data
• Changes in vital signs Participants will have one PAL-222 transplanted to the ulcer site. Researchers will compare before and after the transplantation to see if any safety issues are recognized.

Conditions

Refractory Skin Ulcer

Outcome Measures

Primary Outcomes (1)

• The main measures it aims to answer safety.

  Safety Evaluation: Incidence, type, and severity of Adverse Events (AE)

  28days

Study Arms (1)

Therapeuitic group

EXPERIMENTAL

Procedure: Transplant surgery

Interventions

Transplant surgery PROCEDURE

One piece of PAL-222 is implanted into the ulcer area through the surgical procedure.

Therapeuitic group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Patients aged 20 years or older at the time of obtaining consent (2) Patients with skin ulcers whose ulcer size has decreased by less than 50% compared to before the start of treatment even after 4 weeks or more of conservative standard treatment (3) Patients with an ulcer of 1 cm2 or more and 3 cm2 or less after debridement (4) Patients with ulcers within 5 cm from the ulcer to be treated (5) Patients with no signs of local infection in the ulcer to be treated (6) If the ulcer had the bone exposure, it needs to be within 10% of the ulcer area (7) Patients with skin reflux pressure of 30 mmHg or more at the treatment site (if the patient has an ulcer on the lower leg or foot) (8) Patients who have received a written explanation of this clinical trial from the principal investigator or clinical investigator, fully understood the information, and given their own written consent to participate in this clinical trial (9) Patients who are able to follow oral or written instructions from the principal investigator or clinical investigator

You may not qualify if:

• (1) Patients with any of the following systemic diseases
• Poorly controlled diabetes mellitus (HbA1c greater than 10% at the most recent examination within 28 days prior to enrollment)
• Hypoalbuminemia (serum albumin level less than 2 g/dL)
• Patients requiring continuous oral steroids (prednisolone equivalent greater than 10 mg per day) (2) Patients requiring general anesthesia or lumbar anesthesia during the study period for the following reasons
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• When local anesthesia is not appropriate for debridement due to scarring or hardness of the wound
• Patients who are mentally disturbed, have involuntary movements, or are unable to keep the wound at rest during transplantation (3) Patients with a history of allergy to human serum albumin, trypsin, anesthetics used in this study, antiseptics, or covering materials (4) Patients with abnormal findings on hematology, hematochemistry, coagulation, or urinalysis at the time of screening that would be problematic for participation in the clinical trial (5) Patients with positive HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody, or syphilis serology at screening (6) Patients with severe blood disorders (if any of the following criteria are met)
• <!-- -->
• Hemoglobin less than 10.0 g/dL
• White blood cell count less than 3,000 /microliter
• Neutrophil count less than 1,500 / microliter
• Platelet count less than 75,000 / microliter (7) Patients with severe heart failure (NYHA cardiac function classification III-IV) (8) Patients with severe hepatic impairment (with a history of or complicated by fulminant hepatitis, cirrhosis, liver tumor, or any of the following criteria)
• <!-- -->
• Total bilirubin 1.5x (upper limit of reference value) or higher
• AST (GOP) 3.0x (upper limit of reference value) or more

Sponsors & Collaborators

• PharmaBio Corporation: lead

Study Sites (1)

Kyoto University Hospital

Kyoto, Shogoin-kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan

RECRUITING

MeSH Terms

Conditions

Skin Ulcer

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Hitoshi Kusano, M.D.

CONTACT

+81 44-589-6479; clinicaltrial@pharmabio.co.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: June 11, 2025
• Study Start: April 15, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

JP (1)