Fundación Oftalmológica de Santander

Hematopoietic stem cell transplantation (HSCT) is the treatment of choice for malignant hemopathies, but highlights the limitations of long-term results due to the high toxicity of the procedure and the development of Graft versus Host Disease (GVHD). Conventional treatments for GVHD have limited success rates, and some patients may be refractory to ruxolitinib, a second-line treatment option. As a result, there is a need to explore alternative immuno-modulatory therapies, such as the use of Wharton's jelly mesenchymal stem cells (WJ-MSCs).
The research question aims to investigate the safety and potential benefits of sequentially infusing thawed or expanding allogeneic WJ-MSCs in the treatment of acute GVHD refractory to second-line treatment in patients from the Colombian population. This pilot clinical study is being conducted to address the unmet need for patients who develop GVHD resistant to ruxolitinib.

With the aging of the population, an increase in neurocognitive diseases such as dementia is projected. Mild cognitive impairment is considered a precursor stage to dementia, with opportunities for intervention to prevent its progression. Additionally, these illnesses can harm the primary caregiver, who is often an unskilled family member. This is a randomized clinical trial in patients with mild cognitive impairment and their main caregivers.
The intervention will be tested in the dyad for 12 weeks, twice a week with professional support and once a week with caregiver support, the latter will be intervened once a week for 12 weeks. The primary outcome will be the change in cognitive function and its domains. Secondary outcomes will evaluate favorable changes in quality of life in the patient-caregiver couple, frailty, physical capacity, independence, nutritional status, social support, and family caregiver burden. These measurements will be taken at baseline, 3, 6, and 9 months of follow-up. Furthermore, in a subsample of the study population, the taxonomic and metabolomic composition of the intestinal microbiota and the presence of the E4 allele of the APOE (apolipoprotein E) gene will be evaluated before and after the intervention.

Symptomatic knee osteoarthritis is a serious public health problem in the world, it carries a high personal, social and economic impact. Currently, there are no drugs that modify the natural course of the disease. As analgesic therapy becomes insufficient, more invasive measures are applied, ultimately leading to arthroplasty.
The scientific community has joined efforts to develop new therapeutic approaches that allow the delay and regeneration of injured tissue in these patients. These include cell therapy with mesenchymal stem cells derived from different sources. Although most of the clinical studies carried out in different parts of the world with this therapy in patients with knee osteoarthritis have shown therapeutic benefit, it is necessary to develop clinical trials with high quality in our population.
The aim of this project is to evaluate the safety, tolerance and efficacy of Cellistem-OA (biological therapy based on mesenchymal stem cells derived from Wharton's jelly of umbilical cord) in patients with knee osteoarthritis in the Colombian population.
Investigators proposed to carry out an experimental (clinical trial), randomized, controlled and parallel with 30 participants with knee knee osteoarthritis of the medical complex Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle. The participants will be randomized into two groups: i) 15 patients who will receive a dose of 2 x 106 Cellistem-OA and ii) 15 patients who will receive an active comparator (acetonide of triamcinolone 10mg / mL), which will be administered by intra-articular injection in the superolateral aspect of the knee. The outcomes to be evaluated will be: (i) decrease in joint pain, (ii) increase in joint functionality, (iii) improvement in quality of life and (iv) improvement of articular cartilage. These parameters will be evaluated at weeks 1, 4, 8, 12, 24, 25, 28, 32, 36 and 52 post-treatments. Additionally, local and systemic adverse events will be recorded to establish whether or not there is an association between them and the intervention.