Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT02196467
Eligibility Criteria:
Inclusion Criteria:
* A clinical diagnosis of DMD must be confirmed (i.e., with supporting confirmation demonstrated by the identification of a mutation in the dystrophin gene compatible with DMD or presence of less than 10% dystrophin positive fibers in a muscle biopsy in a subject with DMD).
* The subject has to be older than 16 years of age.
* Male
* If on corticosteroids, a stable dose must be maintained for 6 months prior to myoblast transplantation and throughout the trial
* A potential haplotype compatible donor (the father, the mother, a brother or sister who is more than 18 years old) should be available.
* The subject must be able to move both wrists, with an MRC scale score of greater than or equal to 2.
* Subject must have been vaccinated for pneumococcus and Haemophilus influenzae.
* For subjects who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception for the duration of the study.
* For subjects that need assisted ventilation, a stable regimen of non-invasive ventilation parameters for 3 months prior to the first myoblast transplantation and anticipation that they will be on a stable regimen throughout the study.
* Written informed consent of the subject and donor.
Exclusion Criteria:
* An abnormal sensory examination
* Persisting abnormal values in a hemogram (red blood cells, white blood cells, hemoglobin or platelets out of laboratory normal range).
* A history of chronic infection.
* Abnormal glycosylated hemoglobin level and/or fasting blood glucose (values out of laboratory normal range)
* Previous neoplasia.
* Previous tuberculosis or potential carrier of latent tuberculosis.
* Any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease as determined by the Investigator that is not related to DMD
* Previous history of renal problems or laboratory analyses suggestive of a renal problem (cystatin C, blood urea nitrogen, electrolytes out of laboratory normal range).
* Previous biopsies or intramuscular injections in any of the extensor carpi radialis.
* Subject who participated to phase 1A of myoblast transplantation
* The subject uses a drug that is not compatible with tacrolimus (see section 6 "Concomitant medications" of protocol) within the last month. If the subject has previously used one of these drugs, the washout period before the onset of tacrolimus should be at least 1 month.
* Subject tests positive for HIV-1, HIV-2, antigen HIV-1, HBC (hepatitis B surface antigen (HBsAg) and hepatitis B core antigen) HCV, HTLV-1 and anti-HTLV-2.
* The subject was submitted to electromyography in the extensor carpi radialis, within the last 6 months.
* There are pre-existing antibodies in the subject serum against the donor lymphocytes.
* Any change (initiation, dose adjustment, interruption or discontinuation) in any medication that may affect muscle function (eg. Losartan, coenzyme Q10, green tea extract, idebenone, creatine, nutritional supplements, etc.) within 3 months of the first myoblast transplantation.
* Any change in cardiac medications (ACE inhibitor, beta-blocker, etc.) within 3 months of first myoblast transplantation.
* Any surgery or fracture of the upper extremity within 3 months prior to first myoblast transplantation or plans to have surgery during the course of the trial.
* No haplotype compatible donor is available.
* Unwillingness or inability of the subject to understand and comply with the requirements of this protocol in the opinion of the Investigator or sponsor.
* Previous tuberculosis or potential carrier of latent tuberculosis.
* Previous treatment with any other investigational product within 6 months of myoblast transplantation.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
16 Years
Study:
NCT02196467
Study Brief:
Protocol Section:
NCT02196467