Expanded Access for Patients with Progressive MS
This trial aimed to provide expanded access to intrathecal autologous MSC-NP treatment for patients with progressive multiple sclerosis (MS) who did not qualify for a Phase II clinical trial.
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- #MSResearch
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Why it matters
By focusing on patients with significant disabilities who may not otherwise receive treatment, this research highlights the need for flexibility in clinical trial eligibility and access to potentially beneficial therapies.
What this does not prove
No results from this trial are available, and planned enrollment and endpoints should not be considered findings. The trial is labeled as NO_LONGER AVAILABLE.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- Not reported
- Randomised
- Not reported
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (4)
study design"eligibilityCriteria": "Inclusion Criteria:\n\n* Diagnosis of MS as defined by the McDonald criteria\n* Diagnosis of primary progressive or secondary progressive MS\n* Patients will be 18 years or older\n* Significant disability shown by an Expanded Disability Status Score (EDSS, \\[5\\]) ≥4.5 that was not acquired within the last 12 months \\*(Patients with moderate to severe cerebellar dysfunction who have an EDSS of \\<6.5 who are not eligible for our Ph II Version Date: 11/21/18 Version #4 9 study will be included.
subjects"eligibilityCriteria": "Inclusion Criteria:\n\n* Diagnosis of MS as defined by the McDonald criteria\n* Diagnosis of primary progressive or secondary progressive MS\n* Patients will be 18 years or older\n* Significant disability shown by an Expanded Disability Status Score (EDSS, \\[5\\]) ≥4.5 that was not acquired within the last 12 months \\*(Patients with moderate to severe cerebellar dysfunction who have an EDSS of \\<6.5 who are not eligible for our Ph II Version Date: 11/21/18 Version #4 9 study will be included.
findingsTo give expanded access to intrathecal autologous MSC-NP treatment to patients with progressive MS who do not meet the inclusion/exclusion criteria of our Phase II stem cell trial.
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
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