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Inclusion Body Myositis Treatment With Celution Processed Adipose Derived Regenerative Cells

NCT04975841 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

  • Inclusion Body Myositis

Interventions

DEVICE

Adipose Derived Regenerative Cells

The Cytori Celution technology is an automated version of the process and techniques used in the research laboratory to isolate regenerative cells from adipose tissue. The Cytori Celution System uses a proteolytic enzyme blend (Celase) to disrupt the adipose tissue matrix and release the entrapped adipose derived regenerative cells (ADRCs), also referred to in the literature as "stromal vascular fraction" cells. Once digested, the digestate is separated into fractions (buoyant adipocytes (fat cells) and pelleted ADRCs) by centrifugation. The non-buoyant cell pellet (ADRCs) is then washed and centrifuged through several cycles to remove residual enzyme reagent and cellular debris. Although the Cytori Celution technology replicates known laboratory techniques, it offers significant improvements to the manual laboratory technique by controlling the processing in a closed system that has been validated for safety, performance, and reproducibility.

Sponsors & Collaborators

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Mazen Dimachkie · University of Kansas Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2025-09-26
Completion
2025-09-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04975841 on ClinicalTrials.gov