Therapeutic Treatment of Amyotrophic Lateral Sclerosis (UwmWjmscAls)
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ClinicalTrials.gov Identifier: NCT02881476 |
Recruitment Status : Unknown
Verified August 2016 by Wojciech Maksymowicz, University of Warmia and Mazury.
Recruitment status was: Enrolling by invitation
First Posted : August 29, 2016
Last Update Posted : August 29, 2016
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Condition or disease | Intervention/treatment | Phase |
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Amyotrophic Lateral Sclerosis | Other: Biological: Cell-based therapy | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Application of Wharton's Jelly-derived Mesenchymal Stem Cells in the Treatment of Amyotrophic Lateral Sclerosis |
Study Start Date : | November 2015 |
Estimated Primary Completion Date : | April 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
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Experimental: Allogeneic WJ-MSCs injection
Intervention: Biological: Cell-based therapy of allogeneic Wharton's jelly-derived mesenchymal stem cells which are transplanted intrathecally (via a standard lumbar puncture) into the ALS subjects.
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Other: Biological: Cell-based therapy
Human allogeneic Wharton's jelly-derived mesenchymal stem cell transplantation in ALS patients. |
- Changes in the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) between patients before and after stem cell transplantation. [ Time Frame: From day of enrolment until the date of first stem cell injection (6 months - first time ALSFRS) + and then every 2 months up to 1,5 year of the trial ]ALSFRS is ordinal rating scale questionnaire (rating 0-4 for each question, 4 is most functional, 0-48 total) of 12 functional activities. The most functional total score is 48. The First time the ALSFRS questionnaire has been dane after enrolment of the patients and then after 6 months of observation and stem cell injections the ALSFRS has been dane every 2 months up to 1,5 year of follow-up period.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- diagnosis of the ALS disease before the cell transplantation (diagnose established following the El Escorial criteria for definite ALS)
- good understanding of the protocol and willingness to consent
- signed informed consent
- disease duration: up to 2 years
- FVC > 50% / pulmonologist certificate about respiratory function of the patient
Exclusion Criteria:
- cancer,
- autoimmune diseases
- renal failure,
- subject is a respiratory dependent.
- subject unwilling or unable to comply with the requirements of the protocol
- pregnancy, breastfeeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881476
Principal Investigator: | Wojciech Maksymowicz, MD, Prof. | Faculty of Medical Sciences, University of Warmia and Mazury in Olsztyn, Poland |
Responsible Party: | Wojciech Maksymowicz, MD, PhD, Professor, University of Warmia and Mazury |
ClinicalTrials.gov Identifier: | NCT02881476 |
Other Study ID Numbers: |
UWM/ALS-MSC.2015/001 |
First Posted: | August 29, 2016 Key Record Dates |
Last Update Posted: | August 29, 2016 |
Last Verified: | August 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |