Building a Biobank from Muscle Tissue for Research Purposes
S
Sharon Moe, MD
Primary Investigator
Not Recruiting
18 years - 100 years
All
Phase
N/A
100 participants needed
3 Locations
Brief description of study
What is the purpose of this study?
The purpose of this study is to collect muscle samples and information from individuals for the Indiana Center for Musculoskeletal Health Clinical Research Core Biobank. Each individual’s samples will be given a unique identifier and will be linked to their clinical and demographic information linked through the INPC (via the Regenstrief Institute). The allocation for research will be overseen by a committee of researchers from the Indiana Center for Musculoskeletal Health.
These muscle samples are intended for future research into musculoskeletal health. We hope they will potentially lead to new and better ways to diagnose, treat and prevent muscular diseases as well as assist with other research, such as genetic sequencing.
Detailed description of study
What will happen during the study?
- Participants will be scheduled to come to the Indiana Clinical Research Center to complete an outpatient muscle biopsy procedure within 30 days.
- At the visit, a muscle biopsy (which is a sample of tissue) will be taken from one or both thighs.
- Each muscle biopsy will collect tissue that is approximately a half inch in length, comparable to the size of one Tylenol® caplet.
- This procedure is done while the participant is awake; the doctor will inject a numbing medicine (local anesthesia: lidocaine 1%, similar to what is provided at the dentist) in the biopsy area.
- Several passes of the biopsy needle in the same site may be required to obtain a complete biopsy of muscle tissue; each pass of the needle may result in a muscle tissue sample, approximately a half inch in length.
- Adhesive strips or stitches may be used to close the cut made by the scalpel and antibiotic ointment will be applied to the area.
- Vital signs [blood pressure and pulse] will be taken before and after the biopsy procedure.
- Participants will be monitored for approximately 15 minutes after the last biopsy is completed to make sure they are stable before going home.
- Participants will receive instruction from the study doctor on how to care for the area that was biopsied.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria:
- Able to comprehend and willing to sign an Informed Consent Statement (ICS).
- Body Mass Index less than or equal to 38.
- Participant has not received treatment with any medications with increased bleeding risk (NSAID, Aspirin) within 1 week prior to the muscle biopsy procedure. Acetaminophen may be used.
Exclusion Criteria:
- Participant is known to be HIV or Hepatitis B or C positive.
- Participant has received treatment with NSAID or Aspirin within one week, or warfarin or direct oral anticoagulants (Eliquis, Pradaxa, Xarelto, and Savaysa) within 30 days prior to muscle biopsy procedure.
- Per self-report, any acute or chronic condition that, in the opinion of the Principal Investigator, would limit the procedure participant’s ability to complete and/or participate in this clinical procedure or could influence the biopsy procedure results.
Updated on
11 Nov 2024.
Study ID: 1905097984, NEPH-IIR-MUSCLETISSUEBIOBANK
