OBJECTIVES: Somatic Cell Therapy Medicinal Product (sCTMP) is classed as Advanced Therapy Medicinal Products. Darvadstrocel consists of expanded human allogeneic mesenchymal adult stem cells and is indicated for the treatment of refractory complex perianal fistulas in adult patients with luminal Crohn's disease. The objective was the implementation and optimization of the sCTMP circuit by the pharmacists, in the hospital setting, as pharmacist oversight and handling are required in order to assure the quality, efficacy, and safety for the intended use.

METHODS: The pharmacists undertook specific training for sCTMP handling. Thus, in addition to ensuring the correct order, receipt, and storage, the pharmacists optimize the circuit by delivering and handling darvadstrocel in the operating room, next to the surgeon. Subsequently, the pharmacists evaluated the cell concentration and viability with the trypan blue exclusion test and verified the compliance with the certificate of conformity. The effectiveness of darvadstrocel was evaluated with the outcome of the proportion of patients who remain in clinical remission, with fistulous tract closure, objectified by imaging evaluation, and the absence of pain. A prospective observational study was conducted on eleven patients, who were treated with darvadstrocel, six patients prior and five subsequent to the pharmacists’ intervention in the optimization of the circuit.

RESULTS: The analyzed cell concentration and viability were in conformity with the certificate specification. Of the patients with the pharmacists’ intervention (five patients), 6 months after the surgery, 60% (n=3) were in remission, and 40% (n=2) showed no perianal pain. Of the patients prior to pharmacist intervention (six patients), 12 months after the surgery, 33% (n=2) were in remission, and 50% (n=3) showed no perianal pain.

CONCLUSIONS: The implementation of the sCTMP circuit was successful and accepted by the multidisciplinary team. The optimization of the circuit of darvadstrocel by the pharmacists assured quality, efficacy and safety of the sCTMP use.