Clinical trials

This is a hybrid type two study, with two simultaneous development phases. Phase A involves developing a public-private partnership to create the conditions for implementing CAR-T cell therapies in Colombia. Phase B will be a single-arm, non-randomized pilot clinical trial in patients over 18 years of age with recurrent/refractory (R/R) CD19+ hematopoietic lymphoid neoplasms, including R/R non-Hodgkin lymphoma (NHL), R/R B-cell acute lymphoblastic leukemia (B-ALL), and R/R mantle cell lymphoma; and R/R chronic lymphocytic leukemia (CLL) (including CLL with Richter transformation). This trial aims to determine the safety of administering autologous anti-C19 cells (ARI-0001) and the feasibility of local CAR-T cell production. Phase A of implementation aims to gather information on the domains of the multilevel model, including organizational context, suppliers, infrastructure, and institutional capacities, to identify barriers and facilitators in the implementation of CAR-T cell therapy in Colombia. National consensus will also be developed in the scientific, clinical, administrative, and regulatory spheres. Phase B will involve a pilot clinical trial in patients with relapsed/refractory CD19-positive hematopoietic lymphoid neoplasms. The production of ARI-0001 cells consists of the genetic modification of autologous T cells through lentiviral transduction of a chimeric antigen receptor (CAR) targeting the CD19 surface antigen. The process is carried out in the CliniMACS Prodigy® closed transduction system, which for this study will be located at and operated by staff from the District Institute of Science, Biotechnology, and Innovation in Health (IDCBIS). This pilot clinical trial will use an open-label, single-arm, staggered enrollment design with a safety observation period. The patient will receive the cell product infusion following administration of a lymphodepletion regimen at the National Cancer Institute (NCI). The patient will remain hospitalized for 14 days after the CAR-T cell infusion ARI-001 for medical monitoring, with subsequent outpatient follow-up until 12 months post-infusion. Subsequently, the patient will be offered a new informed consent process to participate in outpatient follow-up for up to 15 years.

The treatment of osteoarthritis (OA) of the knee remains still controversial. Despite that fact advanced stages with symptomatic and functional improvement are obtained with total knee replacement, however, there is no treatment that neither modifies the natural history of this disease, nor avoid joint replacement surgery in young patients in whom the prosthesis has conflictive indications. Moreover, prosthetic surgery leads to lower long-term survival and in older patients, higher morbidity and mortality. Cell therapy promises to be a treatment option through the use of mesenchymal cells with the capacity control inflammatory responses and trigger the differentiation into chondrocytes. Here we propose a randomized placebo-controlled clinical trial to evaluate radiologic and clinical outcomes in patients with knee OA.