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

Musculoskeletal Injury Clinical Trial

Official title: A Patient Sponsored Ongoing Open-label Single-arm, Safety and Efficacy, Phase I/IIb Study of Cellcolabs´ Human Allogeneic Bone-marrow Derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Musculoskeletal Injuries and/or Degeneration

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Musculoskeletal disorders (MSDs) and injuries represent a significant global health concern, constituting the primary cause of disability on a global scale. With a high prevalence spanning various stages of life, from childhood to old age, MSDs exert a substantial burden on individuals and society alike. This burden is particularly amplified in the context of an aging population and the prevalence of multi-morbidity. Chronic illnesses and health conditions not only lead to reduced quality of life but also contribute to a substantial financial burden on societies due to increased healthcare costs and lost productivity. In this context, the inability to work and early retirement are often driven by these health issues, forming a critical dimension of the disease burden.

Regular physical exercise is a crucial factor in promoting longevity and overall well-being. Unfortunately, MSDs can significantly impede individuals' ability to engage in exercise and pursue the hobbies and activities that bring them happiness. These disorders often limit mobility, cause pain, and hinder their capacity to lead an active lifestyle.

Addressing and mitigating these MSDs becomes pivotal in restoring individuals' functional capabilities and quality of life. By effectively managing these conditions, we can empower patients to maintain regular exercise routines that contribute to their physical health, mental well-being, and happiness. Encouraging patients to stay active and engaged not only enhances their own lives but also contributes to a healthier and more vibrant society. Ultimately, the ability to exercise and partake in fulfilling activities stands as a cornerstone for longevity, fostering a balanced and fulfilling life journey.

The spectrum of MSDs encompasses a diverse range of conditions, impacting vital musculoskeletal structures such as bones, joints, muscles, tendons, and ligaments [3]. These disorders can originate from a myriad of factors, including traumatic incidents, degenerative processes, autoimmune responses, and genetic predispositions. The consequence is often chronic pain, compromised mobility, diminished physical function, and a diminished quality of life. Among the array of MSDs, the pervasive influence of osteoarthritis is particularly noteworthy, contributing significantly to the global burden of disease.

Addressing musculoskeletal injuries and degeneration presents an urgent imperative due to the widespread prevalence and devastating impact of these conditions. An emerging avenue of exploration lies in the utilization of mesenchymal stem cells (MSCs), which hold immense potential for revolutionizing regenerative medicine. MSCs, found within diverse tissues including bone marrow and adipose tissue, possess the remarkable ability to differentiate into various cell lineages such as osteocytes, chondrocytes, and myocytes. This intrinsic versatility positions them as key players in tissue regeneration and repair.

The rationale for delving into MSC-based therapies rests upon their extraordinary regenerative potential. When applied to the site of injury or degeneration, MSCs can contribute to the reconstitution of damaged tissues, promoting structural and functional recovery. Moreover, MSCs wield immunomodulatory properties, a crucial attribute given the intricate role of the immune response in MSD progression. By modulating immune cell activity, MSCs can foster an anti-inflammatory environment, counteracting the detrimental effects of chronic inflammation observed in numerous MSDs.

In the larger context, the exploration of mesenchymal stem cells as a therapeutic avenue for musculoskeletal injuries and/or degeneration signifies a pioneering leap within the realm of regenerative medicine. The aspiration to alleviate pain, restore mobility, and enhance functionality holds the promise of ameliorating the extensive repercussions endured by individuals grappling with musculoskeletal disorders. MSCs therapy holds the potential to not only alleviate symptoms and improve the quality of life for individuals with musculoskeletal conditions but also to reduce the economic strain caused by decreased workability and early retirement. By promoting tissue repair, reducing inflammation, and enhancing overall musculoskeletal health, MSCs treatment can contribute to extending a person's productive years and lessening the burden on both individuals and society.

Learning more about stem cell applications for a diverse set of musculoskeletal disorders will allow for more specific studies to be designed and more niched groups of study participants to be targeted. A particularly interesting field of indications and study participants resides in the realm of elite sports. Elite athletes, sports teams, organizations, and federations invest huge resources to push the quality in sports to unprecedented levels. In that quest, sports injuries pose a devastating blocker for the athletes and the organizations as it can hamper an individual's career and the success of a team. With this study, one of our aspirations for the future is to partner up with relevant sports associations, teams, and institutions and leverage sought insights to design a study aimed at offering elite athletes the highest quality treatments to help them stay healthy, and in the unlucky event of an injury, return to their sport in the shortest time possible. ;

Related Conditions & MeSH terms

• Musculoskeletal Injury
• Wounds and Injuries

• NCT number: NCT06074783
• Study type: Interventional
• Source: Cellcolabs Clinical LTD.
• Contact: Rikin Patel, DO
• Phone: +1 (908) 864 2991
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 20, 2023
• Completion date: October 19, 2028