Potency and stability of the drug product
®
One batch of stempeucel® 150 million and two batches of 200 million was manufactured, tested and released for study. The 150 M batch was stable for 36 months, and 200 M batch was stable for 24 months. The viable cell count was 2.33 million cells per 0.8 ml (between 2.18 and 2.76 million at various time points) in 150 M batch and 2.75 million cells per 0.6 ml (between 1.8 and 2.96 million cells at various time points) in both 200 M batches. The minimum limit of cell concentration as per in-house criteria was ≥ 2 million cells. Viable cell count of all the three batches was much above the limit of recommended clinical dose. The identity, purity, potency, genetic stability, safety and impurity of stempeucel® were assessed in all the three batches qualified as per in-house established specification (Fig. Stability of Stempeucel 150 M and 200 M. Preparations 150 M (After screening 32 patients, 24 (21 males and 3 females) of them were enrolled and dosed (included under mITT population) having a mean age of 53 years and weight 60.8 kg (Table Demography and baseline characteristics of patientsCONSORT diagram showing number of patients enrolled, followed up and analyzed