Cellect Biotechnology announces successful transplant using ApoGraft
Cellect Biotechnology (APOP) announced that it has successfully completed transplantation of the first group of three patients using Cellect’s ApoGraft technology in the company’s Phase I/II clinical trial and that after one month follow-up, all three patients have demonstrated complete acceptance of the stem cell transplant with no adverse events related to the study treatment, as determined by the clinical investigator, and no reported serious adverse events or suspected unexpected serious adverse reactions.
The Phase I/II, dose escalating, 4-cohort, open label clinical trial of up to twelve patients is designed to evaluate the safety, tolerability and efficacy of functionally selected donor derived mobilized peripheral blood cells that underwent the company’s ApoGraft process and were transplanted into patients with hematological malignancies in an allogeneic hematopoietic stem cell transplantation.
The primary endpoint of the study is overall incidence, frequency and severity of adverse events potentially related to ApoGraft at 180 days from transplantation. The company plans on recruiting a further three patients for the second cohort of patients following review of the independent data and safety monitoring board.
The company believes that these interim results of ApoGraft present the first signs of a breakthrough in stem cell transplantation.
The product is transplantable within less than 12 hours from donation through a simple process performed on the bedside after selective physiological elimination of immune reaction-causing cells.
The ApoGraft transplantation is intended to result in complete recovery of the patient’s immune system with no related safety concerns in contrast to the significant morbidity or even death causing standard medical procedure.
APOP closed at $7.12. It traded at $9.69 in pre-market trading.
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