A Prospective Randomized Double-Blinded Placebo Controlled, Explorative Phase I Trial to Investigate the Safety and Tolerability of Two Different Doses of Topically Administered APOSEC™ in Healthy Male Subjects With Artificial Dermal Wounds
Condition: Healthy; Artificial Dermal Wound
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective, single center, randomized, double-blinded, placebo-controlled,
      exploratory phase I clinical trial in healthy male subjects to investigate the safety and
      tolerability of the cytokine based gel APOSEC™. The proof of safety and tolerability of
      APOSEC™ is the primary objective. The secondary objective is to measure the extent of wound
      healing of APOSEC™.
    

Detailed description: 
      APOSEC™ is a human product derived from lyophilized conditional medium of peripheral blood
      mononuclear cells (PBMC) following 24 hours cultivation after irradiation with 60Gy. The
      soluble factors produced by these factors (secretome) have regenerative functions and enhance
      wound healing due to the activation of signaling cascades involved in the cell migration,
      proliferation and cell survival. The product also possesses strong angiogenic properties as
      well in vivo and in vitro. APOSEC™ is intended for topical use only, to promote healing of
      wounds in association with standard wound care. Standard wound care includes initial
      debridement, avoidance and treatment of wound related infections and a non-weight-bearing
      regime to decrease the pressure on the wound.

      The verum APOSEC™ is processed as lyophilisate and resuspended in Nugel for the final
      formulation. It will be compared with a placebo, a cell-free parallel produced cell-free
      control lyophilisate that is finally formulated in Nugel as well.

      10 eligible healthy volunteers will consecutively be allocated to 2 different dose groups of
      APOSEC™ in a dose escalation scheme. The first 5 subjects in group A receive the low dose of
      APOSEC™ (12.5*10^6 lyophilized PBMC/mL), the subsequent 5 subjects in group B will receive
      the high dose of APOSEC™ (25*10^6 lyophilized PBMC/mL). Each volunteer will receive both
      Verum and Placebo on two artificial wounds on the inner upper non-dominant arm. The location
      of application of the Verum and Placebo (proximal or distal) is subjected to randomization.
    

Intervention name(s): APOSEC™ for cutaneous use
Intervention type(s): Drug
Intervention description(s): On day 0, a blinded and randomized test treatment with Verum and Placebo is performed on intact skin. If the subject does not reveal any adverse events, the actual treatment phase is initiated 24h later.
Following baseline evaluation on day 1, two punch biopsies (4mm) on the inner upper side of the non-dominant arm are set under local anesthesia. One wound on the upper arm (proximal or distal) will be treated with placebo and the second wound will be treated with the allocated concentration of Verum according to previous randomization scheme set for test treatment. Approximately 1ml of Verum vs. placebo will be applied on the artificial wounds.
From day 2 to 6, artificial wounds will be cleaned with 0.9 % NaCl and then allocated treatment will be administered. Wound dressing will be done daily and will cover the whole area of application.
On day 7 the treatment is terminated and the wound is evaluated with respect the extension of wound closure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: wound healing; APOSEC™; Safety