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Stem Cell Therapy for Inflammatory Muscle Diseases
Study Summary
This trial will study the safety and feasibility of using allogeneic umbilical cord lining stem cells to treat patients with polymyositis or dermatomyositis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have significant muscle loss due to long-term or uncontrolled dermatomyositis or polymyositis, despite treatment.I have recently had or plan to get a live virus vaccine.I do not have conditions like Parkinson's that would affect muscle strength tests.Patients with polymyositis will need to have specific antibodies present or have been checked for other conditions that can look like polymyositis.I have been diagnosed with or treated for cancer, excluding skin cancer, in the last 2 years.I have received an organ transplant.My muscle disease is not caused by my immune system.I have been diagnosed with a specific muscle inflammation disease.I have been diagnosed with dermatomyositis or polymyositis.I expect to need surgery during the trial.My condition is muscle inflammation linked to cancer.You have had a bad reaction to dimethyl sulfoxide (DMSO) in the past.I do not have severe heart, lung diseases, infections, or conditions that could affect the study's safety assessment.My kidney function is severely impaired.You have a history of not following your doctor's treatment instructions.I am 18 years old or older.I have a history of a hole in my heart.Your blood has a low number of a type of white blood cell called neutrophils.
- Group 1: Treatment Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How large is the participant pool for this clinical trial?
"Affirmative. Clinicaltrials.gov provides evidence that this trial is actively recruiting patients and was initially posted on October 6th 2021, with the final edit being done in April 18th 2022. The study requires 22 individuals from a single site to participate."
Are there any specific characteristics that make prospective participants more eligible for this trial?
"This clinical trial is recruiting 22 patients aged between 18 and 90 that have been diagnosed with polymyositis. To qualify, an individual must be of adult age (18+ years old), male or female, present diagnostic criteria matching the Bohan and Peter definition for definitve or probable DM/PM status, evidence of myositis-associated antibody presence or exclusion of mimic conditions according to Investigator's evaluation , and signed informed consent."
Does this research encompass elderly individuals aged 85 or above?
"To be eligible for the trial, individuals should fall within the 18-90 year old range. There are 7 studies tailored to those under 18 and 20 designed for seniors aged 65 or above."
Is this experiment actively seeking individuals to participate?
"As indicated on clinicaltrials.gov, the trial is presently recruiting participants for enrollment. This research was originally posted online in October 2021 and revised most recently in April 2022."
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