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NCT ID: NCT06087848 Recruiting - Clinical trials for Cardiovascular Diseases

A Study to Evaluate Mesenchymal Stem Cell Product StromaForte's Effect on Cardiovascular Events

Start date: October 7, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this phase I/II clinical trial is to evaluate the safety and preventive effect of intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product StromaForte in study participants. The main questions it aims to answer are: To assess the safety and tolerability after 28 days of injection by reporting the number of adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE) To evaluate the effects of Mesenchymal stem cells on Prevention of Cardiovascular Events by following the reported incidence of cardiovascular events amongst study participants up to five year post-injection Participants will receive 100 x 106 allogeneic bone marrow (BM)-derived Mesenchymal Stromal Cell (MSC) formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion 100 million cells in approximately 30 min

NCT ID: NCT06074783 Recruiting - Clinical trials for Musculoskeletal Injury

A Study of Human Allogeneic Bone-marrow Derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Musculoskeletal Injuries and/or Degeneration

Start date: October 20, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this ongoing open-label, single-arm, phase I/IIa study in patients is designed to assess the safety of human allogeneic BM-derived MSCs product StromaForte for musculoskeletal injury or/and degeneration. Any male or female with any musculoskeletal injury and/or degeneration above 18 years will be enrolledThe main questions it aims to answer are: To assess the safety after 28±10, 84±10, 168±10 and 349±10 days of injection by reporting the number of adverse events or severe adverse event assessed by Common Terminology Criteria Change from baseline in subjective pain assessment in each injured and/or degenerated area (if multiple injury is reported, each area to be followed up separately) Eligible patients will receive 50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution of sodium chloride supplemented with human serum albumin to be given locally under ultrasound guidance along with or without 100 x 106 allogeneic BM-derived MSCs formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion in approximately 30 min. Systemic treatment alone is used when local injection at site of injury is not feasible. Additional dose can be administered.

NCT ID: NCT06070532 Not yet recruiting - Frailty Clinical Trials

A Study of Human Allogeneic Bone-marrow-derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Aging Frailty

Start date: January 1, 2025
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this phase I/II clinical trial is to evaluate the safety and tolerability of intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product StromaForte in patients with aging frailty. The main questions it aims to answer are: To assess the safety and tolerability after 28 days of injection by reporting the number of adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE) Observe the change in inflammatory markers from baseline to 6 months (baseline to 28, 84, and 168 days post-infusion.) Participants will receive 100 x 106 allogeneic bone marrow (BM)-derived Mesenchymal Stromal Cell (MSC) formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion 100 million cells in approximately 30 min

NCT ID: NCT05493462 Not yet recruiting - Parkinson Disease Clinical Trials

Intranasal Human FGF-1 for Subjects With Parkinson's Disease

Start date: September 2022
Phase: Phase 1
Study type: Interventional

This is an open-label, pilot study to evaluate the safety, tolerability and efficacy of two dose levels of human FGF-1 administered intranasally to subjects with Parkinson's disease. A low dose of 450 µg FGF-1 (6 µg/kg for a 75 kg subject) and a high dose of 900 µg FGF-1 (12 µg/kg for a 75 kg subject) will be studied sequentially.

NCT ID: NCT03562208 Recruiting - Clinical trials for Diabetes Complications

Autologous Bone Marrow Transplant in Chronic Insulin Dependent Diabetic Patients

Start date: January 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Diabetes, recently declared a pandemic by the World Health Organization, is a risk factor for increased mortality and morbidity. Its multi-functional complications, in the short and long term, are a serious problems for the global public health. Millions of patients, the world over, suffer Diabetes, a chronic and degenerative disease without treatments today. America, and particularly the Caribbean and Central America Region, is seriously affected despite the efforts of the Public Health Systems. Caribbean Region presented nearly twice the incidence and prevalence of type 1 and type 2 diabetes when compared with the rest of the Americas. Today stem cells are emerging as a valid alternative of treatment. In vitro experiments with adult stem cells demonstrated their ability to migrate and differentiate into cells of different lineages. The bone marrow stem cells are safe, effective and have a lot of scientific evidence that supports the carrying out of clinical research in phases II and III. Our protocol is an Autologous Bone Marrow Stem Cell Transplantation, without immune suppression or cell cultures. Our hypothesis is that the stem cells will act as immune modulators, angiogenic and in a regenerative way stimulating quiescent stem cells and improving the metabolic control by endogenous secretion of insulin.

NCT ID: NCT02019264 Completed - Obesity Clinical Trials

A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors

CAMELLIA-TIMI
Start date: January 24, 2014
Phase: Phase 4
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in overweight and obese subjects with cardiovascular (CV) disease and/or multiple CV risk factors.

NCT ID: NCT01745367 Terminated - Clinical trials for Triple Negative Breast Cancer

Tivozanib in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer

BATON-BC
Start date: November 2012
Phase: Phase 2
Study type: Interventional

This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study for subjects with locally recurrent or metastatic triple negative breast cancer.

NCT ID: NCT01706861 Completed - Earlobe Keloids Clinical Trials

A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid Lesions Treated Adjunctive to Surgical Excision

EURO KLEAR
Start date: September 2012
Phase: N/A
Study type: Interventional

The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to reduce the recurrence rate, volume, appearance and/or symptoms associated with keloid scarring in subjects undergoing surgical excision of keloids as compared to the scientific literature.

NCT ID: NCT01446770 Completed - Keloid Clinical Trials

Evaluation of the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181

Start date: November 2010
Phase: Phase 2
Study type: Interventional

The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated with keloid scarring in subjects undergoing surgical revision of keloid scars.

NCT ID: NCT01446159 Completed - Clinical trials for Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer

Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer

Start date: June 13, 2011
Phase: Phase 2
Study type: Interventional

Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.