BradykinesiaPhase 1NCT04385056
Evaluate Umbilical Cord-derived Allogeneic Mesenchymal Stem Cells for the Treatment of Bradykinesia
A Phase 1 study testing MSCTC-0010 in people with Bradykinesia, run by IMAC Holdings, Inc. at 3 sites in United States.
Trial summary
Investigate the safety and tolerability of umbilical cord-derived allogeneic mesenchymal stem cells to treat patients with Bradykinesia. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Bradykinesia
- What is being tested?
- MSCTC-0010
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Dec 2020to 1 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 55 years or older
- Clinically diagnosed with Parkinsonism
- All subjects, or their authorized representatives, must be adequately informed and understand the nature and risks of the study and must be able to provide a signature and date in the Informed Consent Form (ICF).
- Clinically diagnosed bradykinesia for at least 3 months prior to baseline visit.
- On stable treatment regimen with L-dopa and other anti-parkinsonian treatment for 4 weeks prior to baseline.
- Women of child-bearing potential must undergo a negative serum pregnancy test at the screening assessment.
- Subjects, or their representatives, must be able to communicate effectively with the study staff.
- Subjects, or their authorized representatives, must certify that they are able and willing to follow all protocol requirements and study restrictions.
Who cannot join
- Subjects who are intolerant of, or unwilling to, participate in all procedures required of this protocol.
- Subjects who cannot tolerate a venipuncture and/or have adequate venous access.
- Inability to ambulate 100 feet independently with or without an assistive device.
- Subjects who have a history of allergy, hypersensitivity, or intolerance to any medications, components, or excipients of the investigational product or procedures, and which cannot be resolved by the staff conducting the study.
- Subjects with a known diagnosis of Atypical Parkinsonian Syndrome e.g.:
- Dementia with Lewy Bodies;
Show all 42Show fewer
- Progressive Supranuclear Palsy;
- Corticobasal Degeneration;
- Multiple System Atrophy;
- Other Neurodengerative Conditions.
- Head trauma related to the onset of bradykinesia symptoms.
- History of repeated head injury, hydrocephalus, encephalitis, or cerebral tumors.
- Choreoathetosis
- Any documented abnormality in the brain by CT or MRI, which might contribute to the motor function, e.g., stroke, tumor, or other space-occupying lesions, hydrocephalus, or encephalomalacia.
- Known history of serum or plasma progranulin level < 110.9 ng/mL.
- Disease associated mutation in TDP-34, PGRN, CHMPB2, or VCP genes or any other FTLD Causative genes.
- Intracranial operation, e.g., pallidotomy, thalamotomy, and/or deep brain stiumulation surgery.
- Other known neurodegenerative diseases not underlying the bradykinesia, e.g., Spinocerellar Atropy (SCA), Wilson's Disease, or Amyotrphic Lateral Sclerosis (ALS).
- History of other significant neurological or physciatric disorders including, but not limited to, Alzheimer's disease, Lewy Body Dementia, Prior Disease, stroke, or seizure disorder.
- Psychiatric illness that is unrelated to the Bradykinesia, e.g., severe bipolar or unipolar depression.
- History of neurotoxin exposure.
- History of REM behavior disorder.
- Patients with Hepatocellular Carcinoma (HCC).
- Acute liver failure or episode of hepatic encephalopthy.
- Systolic blood pressure greater than 180 or less than 90 mmHg.
- Diastolic blood pressure greater than 105 or less than 50 mmHg.
- Presence of QTcprolongation or ECG abnormal at screening and judged to be clinically significate by the site investigator.
- Clinically significant cardiovascular disease, e.g., cardiac surgery or myocardial infarction within the last 6 months, unstable angina, congestive heart failure, significant cardaic arrthymia; or cogenitial heart disease.
- Early, symptomatic autonomic dysfunction.
- Any malignancy (other than non-metasticic basal cell carcinoma of the skin) with 5 years of screening.
- Clinically significant lab abnormalities at screening, including creatinine ≥ 2.5 mg/dL, vitam B12 below laboratory normal reference range, or TSH above laboratory normal reference range.
- Current clinically significant hematological, endocrine, cardiovascular, renal, heapatic, gastrointestinal, or neurological disease. For the non-cancerconditions, if the condition has been stable for at least the past year and is judged by the site investigator not to interfere with the patient's participation in the study, the patient may be included.
- A history of alcohol or substance abuse within 1 year prior to screening and deemed to be clinically significant by the site investigator.
- An employee or relative of an employee.
- Subjects who have donated plasma or platelets or had a significant loss of whole blood (480 ml or more) within 30 days.
- Subjects who have received blood or blood products within 30 days prior to screening.
- Treatment with any investigational drugs or device or participation in an investigational drug study within 60 days of screening.
- Women of childbearing potential who are not using at least two forms of medically recognized contraception.
- Female subjects who are pregnant, expecting to become pregnant, or lactating/nursing.
- Any subjects who have a clinically significant abnormal laboratory value.
- Subjects who have been treated with another research product 30 days prior to the screening assessment, or plant to participate in another clinical trial, while in this study. If more than 30 days have passed since participation in another clinical trial, the study staff must ensure that the subject has recovered from any adverse events associated with the research product used.
- Subjects who have a history of any other clinically significant disease or disorder that in the opinion of the Principal Investigator, may place the subject at risk due to participation in the study, or may influence the results of the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
David Price IMAC Regeneration Center
Brentwood, Tennessee, 37027
Christine Long, 844-266-4622, contactus@imacregeneration.com
- Recruiting
Ozzie Smith IMAC Regeneration Center
Chesterfield, Missouri, 63017
Christine Long, 844-266-4622, contactus@imacregeneration.com
- Recruiting
IMAC Regeneration Center
Paducah, Kentucky, 42001
Christine Long, 844-266-4622, contactus@imacregeneration.com
About this study
Official title: An Open-label, Dose-escalation Study to Evaluate the Use of Umbilical Cord-derived Allogeneic Mesenchymal Stem Cells (UC-MSCs) for the Treatment of Bradykinesia
Investigate the safety and tolerability of umbilical cord-derived allogeneic mesenchymal stem cells to treat patients with Bradykinesia.
Read the detailed description
While the pathophysiological changes that result in the symptoms of bradykinesia are poorly understood, an inflammatory component appears to be involved. Human umbilical cord-derived allogeneic mesenchymal stem cells have documented anti-inflammatory properties, which suggest these cells may be effective at treating Bradykinesia. It is understood that perinatal products are potent immune modulators. It is believed that the positive symptomatic effects are secondary to the modulation of the immune system, and specifically the reduction in pathological inflammation. The study is designed to evaluate the safety and tolerability of umbilical cord-derived allogeneic mesenchymal stem cells to treat patients with Bradykinesia.
- Conditions
- Bradykinesia
- Being tested
- MSCTC-0010
- Medical subject headings
- Hypokinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCTC-0010Biological
MSCTC-0010 is a suspension product for infusion. The active ingredient is the umbilical cord-derived allogeneic mesenchymal stem cells (US-MSCs).
| Study group | Role | What they receive |
|---|---|---|
| Low Dose MSCTC-0010 | Experimental | Participants will receive low-dose cell administration Receives: Biological: MSCTC-0010 |
| Medium Dose MSCTC-0010 | Experimental | Participants will receive medium-dose cell administration Receives: Biological: MSCTC-0010 |
| High Dose MSCTC-0010 | Experimental | Participants will receive high-dose cell administration Receives: Biological: MSCTC-0010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious Adverse Events and Adverse Events
Number of serious adverse events and adverse events for the duration of the study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start15 Dec 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradykinesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IMAC Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385056
- Sponsor's protocol ID
- IMAC-001
- Status last verified
- Jan 2021
- First submitted
- 5 May 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-escalation Study to Evaluate the Use of Umbilical Cord-derived Allogeneic Mesenchymal Stem Cells (UC-MSCs) for the Treatment of Bradykinesia
- ClinicalTrials.gov ID
- NCT04385056
- Acronym / sponsor ID
- IMAC-001
- Conditions
- Bradykinesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- IMAC Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate the safety and tolerability of umbilical cord-derived allogeneic mesenchymal stem cells to treat patients with Bradykinesia.
Detailed description
While the pathophysiological changes that result in the symptoms of bradykinesia are poorly understood, an inflammatory component appears to be involved. Human umbilical cord-derived allogeneic mesenchymal stem cells have documented anti-inflammatory properties, which suggest these cells may be effective at treating Bradykinesia. It is understood that perinatal products are potent immune modulators. It is believed that the positive symptomatic effects are secondary to the modulation of the immune system, and specifically the reduction in pathological inflammation. The study is designed to evaluate the safety and tolerability of umbilical cord-derived allogeneic mesenchymal stem cells to treat patients with Bradykinesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose MSCTC-0010 | Experimental | Biological: MSCTC-0010Participants will receive low-dose cell administration |
| Medium Dose MSCTC-0010 | Experimental | Biological: MSCTC-0010Participants will receive medium-dose cell administration |
| High Dose MSCTC-0010 | Experimental | Biological: MSCTC-0010Participants will receive high-dose cell administration |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age of 55 years or older
- Clinically diagnosed with Parkinsonism
- All subjects, or their authorized representatives, must be adequately informed and understand the nature and risks of the study and must be able to provide a signature and date in the Informed Consent Form (ICF).
- Clinically diagnosed bradykinesia for at least 3 months prior to baseline visit.
- On stable treatment regimen with L-dopa and other anti-parkinsonian treatment for 4 weeks prior to baseline.
Key exclusion criteria (42 listed)
- Subjects who are intolerant of, or unwilling to, participate in all procedures required of this protocol.
- Subjects who cannot tolerate a venipuncture and/or have adequate venous access.
- Inability to ambulate 100 feet independently with or without an assistive device.
- Subjects who have a history of allergy, hypersensitivity, or intolerance to any medications, components, or excipients of the investigational product or procedures, and which cannot be resolved by the staff conducting the study.
- Subjects with a known diagnosis of Atypical Parkinsonian Syndrome e.g.:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSCTC-0010MSCTC-0010 is a suspension product for infusion. The active ingredient is the umbilical cord-derived allogeneic mesenchymal stem cells (US-MSCs). | Biological | High Dose MSCTC-0010, Low Dose MSCTC-0010, Medium Dose MSCTC-0010 |
Primary outcome
Incidence of Serious Adverse Events and Adverse Events
Time frame: 12 months
Number of serious adverse events and adverse events for the duration of the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSCTC-0010 in people with Bradykinesia, run by IMAC Holdings, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Long (1 (844) 266-4622, contactus@imacregeneration.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Serious Adverse Events and Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.