Inclusion Body Myositis Treatment With Celution Processed Adipose Derived

Status Active, not recruiting

Clinical Trial Summary

This is an open-label, single arm study evaluating the safety for patients with Inclusion Body Myositis. A total of 9 subjects will be enrolled in the study. Subjects will be randomized to Part 1 or Part 2 of the study in blocks of 3 every 3 months. Stem cell injections will be given in the forearm and thigh on either the left or right side of the body, depending on which side meets criteria. The overall goal of this pilot study is to test the safety of adipose derived regenerative cells in patients with Inclusion Body Myositis. If determined safe, this trial could lead to larger Phase II trials. While this specific trial's primary endpoint is safety, it our ultimate hope that ADRC injections into the forearm and thigh of IBM patients will slow, stabilize, or even reverse the progression of muscle weakness in patients with IBM.

Clinical Trial Description

Inclusion Body Myositis (IBM) is the most common progressive and debilitating muscle disease beginning in persons over age 50 years, with an annual incidence estimated at 2.2 to 7.9 per million. IBM causes both proximal and distal muscle weakness, characteristically most prominent in the quadriceps and finger flexors. Over time it can lead to severe disability, including loss of hand function, falls due to quadriceps muscle weakness and foot drop, dysphagia, and eventually respiratory muscle weakness. There is no effective therapy for IBM. This study, "Inclusion Body Myositis Treatment with Celution Processed Adipose Derived Regenerative Cells" (IBM-ADRC) evaluates the safety and efficacy of the Celution System in the processing of an autologous graft consisting of adipose-derived regenerative cells (ADRCs) in the treatment of inclusion body myositis. Specifically, the overall objective is for the proposed clinical trial to serve as a safety trial for Inclusion Body Myositis. This is an open-label, single arm study evaluating the safety for patients with Inclusion Body Myositis. A total of 9 subjects will be enrolled in the study. Subjects will be randomized to Part 1 or Part 2 of the study in blocks of 3 every 3 months. Enrollment is anticipated to be staggered into 3 groups. The nine subjects will be randomized 2:1 in groups of 3 to early injections (Part 2) versus late (Part 1). Stem cell injections will occur unilaterally in the flexor digitorum profundus muscles and the quadriceps group of muscles. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04975841
Study type	Interventional
Source	University of Kansas Medical Center
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 10, 2022
Completion date	November 1, 2025

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See also
Status	Clinical Trial	Phase
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Active, not recruiting	`NCT05046821` - Sporadic Inclusion Body Myositis Natural History Study
Recruiting	`NCT06153108` - Monitoring Biomarker for Detecting Change in Physical Activity and Limb Function in Inclusion Body Myositis Over Time
Active, not recruiting	`NCT04659031` - A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients With (IBM)	Phase 1
Completed	`NCT03440034` - Study of Pioglitazone in Sporadic Inclusion Body Myositis	Phase 1
Terminated	`NCT04049097` - Arimoclomol in Sporadic Inclusion Body Myositis - Open Label Extension Trial	Phase 3
Completed	`NCT00001261` - Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory Myopathies	Phase 2
Recruiting	`NCT05272969` - Pompe & Pain - Study to Assess Nociceptive Pain in Adult Patients With Pompe Disease
Completed	`NCT01734369` - Environmental Risk Factors for Myositis in Military Personnel
Recruiting	`NCT00017914` - Adult and Juvenile Myositis
Completed	`NCT00917956` - Lithium in Inclusion Body Myositis (IBM)	N/A
Completed	`NCT03633318` - Establishing Muscle Impedance Parameters With Electrical Impedance Myography
Recruiting	`NCT04789070` - Phase III Trial of Sirolimus in IBM	Phase 3
Active, not recruiting	`NCT05721573` - A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis	Phase 2/Phase 3
Recruiting	`NCT05032131` - Cell Therapy for IBM by Muscle Injection of ADSVF	Phase 1
Completed	`NCT03299335` - Molecular Profile of the Evolution of Inclusion Body Myositis	N/A
Completed	`NCT04421677` - Safety and Tolerability of Phenylbutyrate in Inclusion Body Myositis	Phase 1
Completed	`NCT02753530` - Study of Arimoclomol in Inclusion Body Myositis (IBM)	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Inclusion Body Myositis Treatment With Celution Processed Adipose Derived Regenerative Cells

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms