University of Sao Paulo — Biomedical Watch V2

Traitements8programmes

Essais4liés

Publications3liées

SourceDBlocale

Traitements

8

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Autologous CD19-Directed CAR-T Cells Manufactured at Ribeirão Preto Blood CenterSystemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks the body's own tissues and organs. The disease can affect the skin, joints, kidneys, blood cells, brain, and other organs, leading to significant health problems and reduced quality of life. Although several treatments are available, some patients continue to have active disease despite receiving standard therapies. Recent research has shown that B cells, a type of immune cell, play a central role in the development and persistence of SLE. CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy is an innovative treatment that uses a patient's own immune cells, genetically modified to recognize and eliminate B cells. This approach has already shown remarkable success in certain blood cancers and has recently produced encouraging results in patients with severe autoimmune diseases, including SLE. The CLEVER-SLE study is a Phase I/II clinical trial designed to evaluate the safety and potential effectiveness of CD19-directed CAR-T cell therapy produced at Ribeirao Preto Blood Bank in patients with SLE who have not responded adequately to conventional treatments. Participants will undergo the collection of their own immune cells, which will be modified in a specialized laboratory to produce CAR-T cells. After receiving preparatory chemotherapy, participants will receive a single intravenous infusion of these CAR-T cells. The main goal of this study is to evaluate the safety of this treatment. Researchers will also assess its effects on disease activity, symptoms, organ involvement, medication requirements, immune system markers, and the duration of clinical responses. The study aims to determine whether CD19-directed CAR-T cell therapy can provide a new treatment option for patients with refractory SLE and contribute to the development of CAR-T therapies for autoimmune diseases.	Lupus	Phase 1/2	Thérapie cellulaire + Immunomodulation	Brazil	À vérifier
AyahuascaOpen label intervention with a single dose of ayahuasca in patients with psychogenic non-epileptic seizures (PNES)	Épilepsie	Phase 1/2	À vérifier	Brazil	À vérifier
Effects of Prayer on Pain Thresholds and Scores of Anxiety and Depression in Participants With and Without MigraineThis study comprised two separate assessor-blinded randomized crossover experiments, one in participants with migraine and one in participants without migraine. Within each cohort, participants completed two experimental conditions on separate study visits: 10 minutes of self-selected personal prayer and 10 minutes of non-spiritual reading. The order of the two conditions was randomized within each cohort. The primary outcome was cephalic pressure pain threshold (PPT), assessed immediately before and after each experimental condition at eight craniofacial sites. The study examined acute changes in PPT following prayer and reading. Spiritual well-being, religiosity, anxiety symptoms, and depressive symptoms were assessed once at baseline to characterize the participants and were not repeated following the experimental conditions. A total of 109 participants were enrolled: 57 participants with migraine and 52 participants without migraine.	Migraine	Non applicable	Traitement symptomatique	Brazil	À vérifier
SLE-OMEGA — Omega-3 Supplementation in Systemic Lupus ErythematosusThis randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether oral omega-3 fatty acid supplementation can modulate inflammation, oxidative stress, and telomere maintenance in women with systemic lupus erythematosus (SLE) in remission. Women aged 18-45 years with SLE (SLEDAI-2K ≤ 4) will be allocated to receive either omega-3 (5,400 mg/day of EPA+DHA) or placebo for 12 weeks. A parallel healthy control group will undergo the same intervention scheme. Clinical, biochemical, and molecular assessments including inflammatory cytokines, oxidative stress markers (TBARS, ORAC, T-AOC), and relative telomere length (T/S ratio) will be conducted at baseline and post-intervention. The trial is designed to determine whether omega-3 can attenuate chronic low-grade inflammation and oxidative imbalance, both key drivers of cellular dysfunction and premature immunosenescence in SLE. Omega-3 PUFAs exert anti-inflammatory effects through competition with arachidonic acid for COX/LOX enzymes and by activating GPR120, which inhibits the TAK1-NF-κB-JNK inflammatory cascade. Their antioxidant effects may further reduce reactive oxygen species and support genomic stability. By integrating clinical, biochemical, and molecular outcomes, this study provides a comprehensive evaluation of omega-3 effects on pathways implicated in accelerated cellular aging in autoimmune diseases. The findings are expected to clarify whether omega-3 supplementation represents a safe, low-cost strategy capable of improving inflammatory and oxidative profiles and contributing to telomere preservation in women with SLE, supporting future precision-nutrition approaches in this population.	Lupus	Non applicable	Immunomodulation + Neuroprotection		À vérifier
AyahuascaOpen label intervention with a single dose of ayahuasca in patients with psychogenic non-epileptic seizures (PNES)	Épilepsie	Phase 1/2	À vérifier	Brazil	À vérifier
SLE-OMEGA — Omega-3 Supplementation in Systemic Lupus ErythematosusThis randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether oral omega-3 fatty acid supplementation can modulate inflammation, oxidative stress, and telomere maintenance in women with systemic lupus erythematosus (SLE) in remission. Women aged 18-45 years with SLE (SLEDAI-2K ≤ 4) will be allocated to receive either omega-3 (5,400 mg/day of EPA+DHA) or placebo for 12 weeks. A parallel healthy control group will undergo the same intervention scheme. Clinical, biochemical, and molecular assessments including inflammatory cytokines, oxidative stress markers (TBARS, ORAC, T-AOC), and relative telomere length (T/S ratio) will be conducted at baseline and post-intervention. The trial is designed to determine whether omega-3 can attenuate chronic low-grade inflammation and oxidative imbalance, both key drivers of cellular dysfunction and premature immunosenescence in SLE. Omega-3 PUFAs exert anti-inflammatory effects through competition with arachidonic acid for COX/LOX enzymes and by activating GPR120, which inhibits the TAK1-NF-κB-JNK inflammatory cascade. Their antioxidant effects may further reduce reactive oxygen species and support genomic stability. By integrating clinical, biochemical, and molecular outcomes, this study provides a comprehensive evaluation of omega-3 effects on pathways implicated in accelerated cellular aging in autoimmune diseases. The findings are expected to clarify whether omega-3 supplementation represents a safe, low-cost strategy capable of improving inflammatory and oxidative profiles and contributing to telomere preservation in women with SLE, supporting future precision-nutrition approaches in this population.	Lupus	Non applicable	Immunomodulation + Neuroprotection		À vérifier
Effects of Prayer on Pain Thresholds and Scores of Anxiety and Depression in Participants With and Without MigraineThis study comprised two separate assessor-blinded randomized crossover experiments, one in participants with migraine and one in participants without migraine. Within each cohort, participants completed two experimental conditions on separate study visits: 10 minutes of self-selected personal prayer and 10 minutes of non-spiritual reading. The order of the two conditions was randomized within each cohort. The primary outcome was cephalic pressure pain threshold (PPT), assessed immediately before and after each experimental condition at eight craniofacial sites. The study examined acute changes in PPT following prayer and reading. Spiritual well-being, religiosity, anxiety symptoms, and depressive symptoms were assessed once at baseline to characterize the participants and were not repeated following the experimental conditions. A total of 109 participants were enrolled: 57 participants with migraine and 52 participants without migraine.	Migraine	Non applicable	Traitement symptomatique	Brazil	À vérifier
Autologous CD19-Directed CAR-T Cells Manufactured at Ribeirão Preto Blood CenterSystemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks the body's own tissues and organs. The disease can affect the skin, joints, kidneys, blood cells, brain, and other organs, leading to significant health problems and reduced quality of life. Although several treatments are available, some patients continue to have active disease despite receiving standard therapies. Recent research has shown that B cells, a type of immune cell, play a central role in the development and persistence of SLE. CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy is an innovative treatment that uses a patient's own immune cells, genetically modified to recognize and eliminate B cells. This approach has already shown remarkable success in certain blood cancers and has recently produced encouraging results in patients with severe autoimmune diseases, including SLE. The CLEVER-SLE study is a Phase I/II clinical trial designed to evaluate the safety and potential effectiveness of CD19-directed CAR-T cell therapy produced at Ribeirao Preto Blood Bank in patients with SLE who have not responded adequately to conventional treatments. Participants will undergo the collection of their own immune cells, which will be modified in a specialized laboratory to produce CAR-T cells. After receiving preparatory chemotherapy, participants will receive a single intravenous infusion of these CAR-T cells. The main goal of this study is to evaluate the safety of this treatment. Researchers will also assess its effects on disease activity, symptoms, organ involvement, medication requirements, immune system markers, and the duration of clinical responses. The study aims to determine whether CD19-directed CAR-T cell therapy can provide a new treatment option for patients with refractory SLE and contribute to the development of CAR-T therapies for autoimmune diseases.	Lupus	Phase 1/2	Thérapie cellulaire + Immunomodulation	Brazil	À vérifier

Essais cliniques

4

Molécule	Indication / population	Phase	NCT	Titre	Statut
Autologous CD19-Directed CAR-T Cells Manufactured at Ribeirão Preto Blood Center	Lupus	Phase 1/2	NCT07659704	CLEVER-SLE — CD19-Directed CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus	NOT_YET_RECRUITING
Effects of Prayer on Pain Thresholds and Scores of Anxiety and Depression in Participants With and Without Migraine	Migraine	Non applicable	NCT07143461	Effects of Prayer on Pain Thresholds and Scores of Anxiety and Depression in Participants With and Without Migraine	COMPLETED
SLE-OMEGA — Omega-3 Supplementation in Systemic Lupus Erythematosus	Lupus	Non applicable	NCT07393399	SLE-OMEGA — Omega-3 Supplementation in Systemic Lupus Erythematosus	NOT_YET_RECRUITING
Ayahuasca	Épilepsie	Phase 1/2	NCT07747324	Effects of a Sigle Dose of Ayahuasca in Patients With Psychogenic Non-epileptic Seizures: an Open Label Clinical Trial	RECRUITING

Publications

3

Molécule	Indication / population	Titre	Journal	Date
Ayahuasca		Barriers and Facilitators for Psychedelic Research and Regulation in Brazil: Insights From Diverse Stakeholders.	Clinical therapeutics
Ayahuasca		Where is the sweet spot for psychedelic-enhanced fear extinction? An integrative quantitative synthesis of dose-effect patterns in rodent models.	Journal of psychopharmacology (Oxford, England)
Ayahuasca		Therapeutic properties of ayahuasca component N,N-Dimethyltryptamine in a pre-clinical model of Parkinson's disease.	Experimental neurology