Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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24 March 2025 |
Main ID: |
NCT05167721 |
Date of registration:
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30/11/2021 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Randomized Double-Blind Placebo-Controlled Adaptive Design Trial Of Intrathecally Administered Autologous Mesenchymal Stem Cells In Multiple System Atrophy
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Scientific title:
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Randomized Double-Blind Placebo-Controlled Adaptive Design Trial Of Intrathecally Administered Autologous Mesenchymal Stem Cells In Multiple System Atrophy |
Date of first enrolment:
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December 15, 2021 |
Target sample size:
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76 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/ct2/show/NCT05167721 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Tonette Gehrking |
Address:
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Telephone:
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507-284-0336 |
Email:
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adc.research@mayo.edu |
Affiliation:
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Name:
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Tonette Gehrking |
Address:
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Telephone:
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(507) 284-0336 |
Email:
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adc.research@mayo.edu |
Affiliation:
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Name:
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Wolfgang Singer, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Males or females aged 30-70 years, who are willing and able to give informed
consent.
2. Clinical diagnosis of MSA, fulfilling consensus criteria for probable MSA.
3. UMSARS I (omitting question 11) between 5 and 17, and able to walk unaided (i.e.
able to walk at least 50 yards without the use of a cane or walker, and without
other support such as holding on to an arm or touching walls).
4. Anticipated survival of at least 3 years in the opinion of the investigator.
5. Normal cognition as assessed by the Montreal Cognitive Assessment (MOCA). We will
require a value =26.
Exclusion Criteria:
1. Pregnant or breastfeeding women, and women of childbearing potential who do not
agree to practice an acceptable method of birth control. Acceptable methods of birth
control in this study are: surgical sterilization, intrauterine devices, partner's
vasectomy, a double-protection method (condom or diaphragm with spermicide),
hormonal contraceptive drug (i.e., oral contraceptive, contraceptive patch,
long-acting injectable contraceptive) with a required second mode of contraception.
2. Participants with a clinically significant or unstable medical or surgical condition
that, in the opinion of the investigator, might preclude safe completion of the
study or might affect study results. These include conditions causing significant
CNS or autonomic dysfunction, clinically significant peripheral neuropathy, active
malignant neoplasm, amyloidosis, active autoimmune disease, immunocompromised state,
active infection, congestive heart failure (NYHA III or IV), recent (<6 months)
myocardial infarction, history of stoke with residual deficits, uncontrolled
diabetes mellitus, alcoholism, orthopedic problems that compromise mobility and
activity of daily living, significant liver or kidney disease, thrombocytopenia (<50
x 109/L), disorders affecting coagulation, and patients on active anticoagulation.
3. Participants who have taken any investigational products within 90 days prior to
baseline, or with expected effects lasting beyond 60 days prior to baseline.
4. Medications that could affect clinical evaluations are permitted but need to be
withdrawn at least four half-lives prior to study visits. Those include medications
used to treat motor symptoms, such as levodopa and other anti-Parkinsonian
medications.
5. Patients with contraindication to any of the study procedures, in particular MRI
scanning.
Age minimum:
30 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple System Atrophy
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Intervention(s)
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Other: Placebo
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Biological: Autologous Mesenchymal Stem Cells
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Primary Outcome(s)
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Change in UMSARS total (= UMSARS I + UMSARS II) score
[Time Frame: 12 months]
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Secondary Outcome(s)
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Change in UMSARS II score
[Time Frame: 12 months]
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Change in COMPASS select score
[Time Frame: 12 months]
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Change in modified UMSARS score
[Time Frame: 12 months]
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Rate of atrophy of selected brain regions
[Time Frame: 12 months]
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Change in UMSARS I score
[Time Frame: 12 months]
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Secondary ID(s)
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FD-R-07290-01
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21-005569
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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