Multiple Sclerosis, Relapsing-RemittingEarly Phase 1MSFibroblastNCT05080270
Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis
A Early Phase 1 study testing Tolerogenic Fibroblasts in people with Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis, run by FibroBiologics at 1 site in Mexico.
Trial summary
Fibroblasts have demonstrated potent immune modulatory and therapeutic activity in the experimental autoimmune encephalomyelitis (EAE) model of multiple sclerosis, as well as in other models of autoimmune and inflammatory diseases. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
- What is being tested?
- Tolerogenic Fibroblasts
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteMexico
- Study dates
- 21 Sep 2020to 8 Jun 2021
- Phase
- Early 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients willing to sign an informed consent and capable of understanding the features of this clinical trial.
- Willing to keep a weekly diary and undergo observation for four months
- Non-pregnant patients 18-55 years of age with MS according to the revised McDonald criteria and meeting the Possner criteria for clinically defined MS.
- EDSS scores of 2·0 to 5·5 points assessed at least three months after the last acute attack of MS.
Who cannot join
- Patients with evidence of active proliferative retinopathy.
- Patients with poorly controlled diabetes mellitus (HbA1C > 8.5%).
- Patients with renal insufficiency (Creatinine > 2.5) or failure.
- Infection as evidenced by WBC count of >15,000 k/cumm and/or temperature >38C.
- History of organ transplant.
- History of previous or active malignancy, except for localized cutaneous basal or squamous cell carcinoma or carcinoma in situ of the cervix
Show all 14Show fewer
- History of sickle cell anemia
- Cardiovascular conditions:
- Exercise limiting angina ( Canadian Cardiovascular Society Class greater or equal to 3
- Congestive heart failure (New York Heart Association class greater or equal to 3
- Unstable angina
- Acute ST elevation myocardial infarction (MI) within one month
- Transient ischemic attack or stroke within one month
- Severe valvular disease
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Servicios Medicos UCC, S.C.
Tijuana, Estado de Baja California, 22504
About this study
Fibroblasts have demonstrated potent immune modulatory and therapeutic activity in the experimental autoimmune encephalomyelitis (EAE) model of multiple sclerosis, as well as in other models of autoimmune and inflammatory diseases.
This study will assess primary safety and secondary efficacy endpoints of intravenous administration of 100 million tolerogenic fibroblasts to 5 patients with relapsing remitting MS resistant to interferon. While the safety of fibroblasts administered clinically is established, it is unknown whether these cells are effective in the treatment of multiple sclerosis (MS).
Our hypothesis is that the tolerogenic fibroblasts will be well-tolerated and meet our primary objective. In addition, The investigators are optimistic that they will see signs of efficacy based on the following: Neurological assessment of the MS functional composite assessment which comprises of EDSS, the expanded EDSS (Rating Neurologic Impairment in Multiple Sclerosis, the Scripps neurological rating scale (NRS), paced auditory serial addition test (PASAT), the nine-hole peg test, and 25-foot walking time, short-form 36 (SF-36) quality of life questionnaire and gadolinium-enhanced MRI scans of the brain and cervical spinal cord.
Read the detailed description
Fibroblasts have demonstrated potent immune modulatory and therapeutic activity in the experimental autoimmune encephalomyelitis (EAE) model of multiple sclerosis, as well as in other models of autoimmune and inflammatory diseases. Mechanistically, tolerogenic fibroblasts produce anti-inflammatory and immune modulatory factors, which appear to be therapeutic in the context of autoimmunity, including IL-10 and TGF-beta. Additionally, tolerogenic fibroblasts produce neurotrophic mediators that enhance myelin production and/or prevent neuronal apoptosis.
This study will assess primary safety and secondary efficacy endpoints of intravenous administration of 100 million tolerogenic fibroblasts to 5 patients with relapsing remitting MS resistant to interferon. While the safety of fibroblasts administered clinically is established, it is unknown whether these cells are effective in the treatment of multiple sclerosis (MS).
Research Hypothesis: Intravenous administration of 100 million tolerogenic fibroblasts will be well tolerated and induce a therapeutic effect in relapse remitting MS patients.
Rationale: The family of Mesenchymal Stem Cells (MSCs) is immune-modulatory, and bone marrow MSCs (BM-MSCs) have induced therapeutic responses in patients with MS [1]. Tolerogenic fibroblasts possess superior immune modulatory activity compared to BM-MSCs and adipose MSCs. The investigators, therefore, seek to perform a five-patient trial to assess the safety and signs of efficacy of this cell population in MS patients resistant to interferon.
The trial's primary objective is freedom from treatment-associated adverse events at 1, 2, 4, 8, and 16 weeks post-treatment. The study's secondary objective will be efficacy as assessed at baseline, weeks 2, 4, 8, and 16. The results will be quantified based on the following: Neurological assessment of the MS functional composite assessment, which comprises of EDSS, the expanded EDSS (Rating Neurologic Impairment in Multiple Sclerosis, the Scripps neurological rating scale (NRS), paced auditory serial addition test (PASAT), the nine-hole peg test, and 25-foot walking time, short-form 36 (SF-36) quality of life questionnaire and gadolinium-enhanced MRI scans of the brain and cervical spinal cord.
- Being tested
- Tolerogenic Fibroblasts
- Keywords
- MS, Cell Therapy, Fibroblasts, Fibrobiologics, Stem cells, regenerative medicine, tissue regeneration, Immune modulation
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolerogenic FibroblastsBiological
administrating single dose of 100 million tolerogenic fibroblasts via intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| tolerogenic fibroblasts administered via intravenous infusion | Experimental | A single dose of 100 million tolerogenic fibroblasts administered via intravenous infusion. Receives: Biological: Tolerogenic Fibroblasts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Adverse even monitoring of subjects for 4 hours after infusion
Monitor subjects for possible treatment-related acute immune symptoms or vascular occlusion symptoms during the administration of the allogeneic tolerogenic fibroblasts via intravenous infusion.
Measured: Monitoring during the Intravenous infusion of allogeneic tolerogenic fibroblasts, and continued for 4 hours after infusion
Safety: Complete Blood Count to monitor inflammation markers
Complete Blood Count used to monitor inflammation markers included white blood cell (WBC), neutrophil (N), lymphocyte (L), neutrophil-lymphocyte ratio (NLR), mean platelet volume (MPV), and platelet-lymphocyte ratio. This safety test is to monitor subjects for inflammation during the course of the study, relating to the course of the disease, or allogeneic tolerogenic fibroblasts administered through Intravenous infusion
Measured: Day before infusion to establish a baseline, week 8, and week 16 after infusion
Safety: Serum chemistry to monitor impact on serum chemistry
This test will measure the amount of certain substances in serum samples, including electrolytes (such as sodium, potassium, and chloride), fats, proteins, glucose (sugar), and enzymes. Blood chemistry tests give essential information about how well a person's kidneys, liver, and other organs are working. An abnormal amount of a substance in the blood can be a sign of disease or a side effect of treatment. Blood chemistry tests help diagnose and monitor many conditions before, during, and after treatment. Also called blood chemistry study.
Measured: Day before infusion to establish a baseline, week 8, and week 16 after infusion
Safety: 12-lead Electrocardiogram (ECG) to monitor cardiovascular health
A 12-lead electrocardiogram will be used to monitor the baseline cardiovascular health of the participants and continue to monitor their cardiovascular health during the course of the study measuring heart rate, blood pressure, ventricular rate, PR interval, RP interval, QRS interval, and GT interval. This safety test is to monitor the subjects for cardiac events related to the course of the disease, or allogeneic tolerogenic fibroblasts administered through Intravenous infusion
Measured: Day before infusion to establish a baseline, week 8, and week 16 after infusion
Secondary outcomes (5)
Efficacy: Expanded Disability Status Scale (EDSS) to quantify disability scale and monitors changes
The Expanded Disability Status Scale (EDSS) quantifies disability in multiple sclerosis and monitors changes in the level of disability over time. The test is based on neurological examination and impact on Functional Systems representing network of neurons in the brain. It is widely used in clinical trials and the assessment of people with MS. The scale was developed by a neurologist called John Kurtzke in 1983 as an advance from his previous 10 step Disability Status Scale (DSS). The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.
Measured: Day before infusion to establish a baseline, week 8, and week 16 after infusion
Efficacy: Paced Auditory Serial Addition Test (PASAT) to measure cognitive function and processing speed
PASAT is a measure of cognitive function that assesses auditory information processing speed, flexibility, and calculation ability. The test was developed by Gronwell in 1977 and later adapted by Rao and colleagues in 1989 for use in MS. The PASAT is presented using audio cassette tape or compact disk to ensure standardization in the rate of stimulus presentation. In the test, single digits are presented every 3 seconds, and the patient must add each new digit to the one immediately prior to it. Shorter inter-stimulus intervals, e.g., 2 seconds or less, have also been used with the PASAT but tend to increase the difficulty of the task.
Measured: Day before infusion to establish a baseline, week 8, and week 16 after infusion
Efficacy: Nine-Hole Peg Test to measure and quantify upper extermity function
The 9-HPT is a brief, standardized, quantitative test of upper extremity function. Both the dominant and non-dominant hands are tested twice. The patient is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the patient picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand.
Measured: Day before infusion to establish a baseline, week 8, and week 16 after infusion
Efficacy: Timed 25-Foot Walk Test to quantify mobility and leg function
The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task.
Measured: Day before infusion to establish a baseline, week 8, and week 16 after infusion
Efficacy: Gadolinium Enhanced MRI to detect demyelinated areas of the nerves
Gadolinium Enhanced MRI is used to detect demyelinated areas of the nerves in the brain and cervical spinal cord. These Damaged areas can be observed by MRI presented as plaques, and the intensity of the plaques can determine the age of multiple sclerosis caused lesions.
Measured: Day before infusion to establish a baseline, and week 16 after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start21 Sep 2020
- Primary completion8 Jun 2021
- Study completion8 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The proposed study will assess primary safety and secondary efficacy endpoints of allogeneic tolerogenic fibroblasts administered through Intravenous infusion at a single dose of 100 million cells to 5 patients with relapsing remitting MS resistant to interferon.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- FibroBiologics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hamid Khoja, Ph.D., Study director, FibroBiologics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080270
- Sponsor's protocol ID
- Fibroblast_MS_safety2021
- Acronym
- MSFibroblast
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Connick P, Kolappan M, Crawley C, Webber DJ, Patani R, Michell AW, Du MQ, Luan SL, Altmann DR, Thompson AJ, Compston A, Scott MA, Miller DH, Chandran S. Autologous mesenchymal stem cells for the treatment of secondary progressive multiple sclerosis: an open-label phase 2a proof-of-concept study. Lancet Neurol. 2012 Feb;11(2):150-6. doi: 10.1016/S1474-4422(11)70305-2. Epub 2012 Jan 10.
PubMed 22236384Kantarci O, Wingerchuk D. Epidemiology and natural history of multiple sclerosis: new insights. Curr Opin Neurol. 2006 Jun;19(3):248-54. doi: 10.1097/01.wco.0000227033.47458.82.
PubMed 16702830Evans C, Beland SG, Kulaga S, Wolfson C, Kingwell E, Marriott J, Koch M, Makhani N, Morrow S, Fisk J, Dykeman J, Jette N, Pringsheim T, Marrie RA. Incidence and prevalence of multiple sclerosis in the Americas: a systematic review. Neuroepidemiology. 2013;40(3):195-210. doi: 10.1159/000342779. Epub 2013 Jan 24.
PubMed 23363936Ghasemi N, Razavi S, Nikzad E. Multiple Sclerosis: Pathogenesis, Symptoms, Diagnoses and Cell-Based Therapy. Cell J. 2017 Apr-Jun;19(1):1-10. doi: 10.22074/cellj.2016.4867. Epub 2016 Dec 21.
PubMed 28367411Navikas V, Link H. Review: cytokines and the pathogenesis of multiple sclerosis. J Neurosci Res. 1996 Aug 15;45(4):322-33. doi: 10.1002/(SICI)1097-4547(19960815)45:43.0.CO;2-B.
PubMed 8872892Marrie RA, Elliott L, Marriott J, Cossoy M, Blanchard J, Leung S, Yu N. Effect of comorbidity on mortality in multiple sclerosis. Neurology. 2015 Jul 21;85(3):240-7. doi: 10.1212/WNL.0000000000001718. Epub 2015 May 27.
PubMed 26019190Goldman MD, Motl RW, Rudick RA. Possible clinical outcome measures for clinical trials in patients with multiple sclerosis. Ther Adv Neurol Disord. 2010 Jul;3(4):229-39. doi: 10.1177/1756285610374117.
PubMed 21179614SCHUMACHER GA, BEEBE G, KIBLER RF, KURLAND LT, KURTZKE JF, MCDOWELL F, NAGLER B, SIBLEY WA, TOURTELLOTTE WW, WILLMON TL. PROBLEMS OF EXPERIMENTAL TRIALS OF THERAPY IN MULTIPLE SCLEROSIS: REPORT BY THE PANEL ON THE EVALUATION OF EXPERIMENTAL TRIALS OF THERAPY IN MULTIPLE SCLEROSIS. Ann N Y Acad Sci. 1965 Mar 31;122:552-68. doi: 10.1111/j.1749-6632.1965.tb20235.x. No abstract available.
PubMed 14313512Polman CH, Rudick RA. The multiple sclerosis functional composite: a clinically meaningful measure of disability. Neurology. 2010 Apr 27;74 Suppl 3:S8-15. doi: 10.1212/WNL.0b013e3181dbb571.
PubMed 20421572Rodgers JM, Robinson AP, Miller SD. Strategies for protecting oligodendrocytes and enhancing remyelination in multiple sclerosis. Discov Med. 2013 Aug;16(86):53-63.
PubMed 23911232Ernstsson O, Gyllensten H, Alexanderson K, Tinghog P, Friberg E, Norlund A. Cost of Illness of Multiple Sclerosis - A Systematic Review. PLoS One. 2016 Jul 13;11(7):e0159129. doi: 10.1371/journal.pone.0159129. eCollection 2016.
PubMed 27411042Hartung DM, Bourdette DN, Ahmed SM, Whitham RH. The cost of multiple sclerosis drugs in the US and the pharmaceutical industry: Too big to fail? Neurology. 2015 May 26;84(21):2185-92. doi: 10.1212/WNL.0000000000001608. Epub 2015 Apr 24.
PubMed 25911108Frampton JE. Ocrelizumab: First Global Approval. Drugs. 2017 Jun;77(9):1035-1041. doi: 10.1007/s40265-017-0757-6.
PubMed 28523586Offner H, Sinha S, Burrows GG, Ferro AJ, Vandenbark AA. RTL therapy for multiple sclerosis: a Phase I clinical study. J Neuroimmunol. 2011 Feb;231(1-2):7-14. doi: 10.1016/j.jneuroim.2010.09.013. Epub 2010 Oct 20.
PubMed 20965577Karussis D, Karageorgiou C, Vaknin-Dembinsky A, Gowda-Kurkalli B, Gomori JM, Kassis I, Bulte JW, Petrou P, Ben-Hur T, Abramsky O, Slavin S. Safety and immunological effects of mesenchymal stem cell transplantation in patients with multiple sclerosis and amyotrophic lateral sclerosis. Arch Neurol. 2010 Oct;67(10):1187-94. doi: 10.1001/archneurol.2010.248.
PubMed 20937945
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05080270
- Acronym / sponsor ID
- MSFibroblast / Fibroblast_MS_safety2021
- Keywords
- MS, Cell Therapy, Fibroblasts, Fibrobiologics, Stem cells, regenerative medicine, tissue regeneration, Immune modulation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- FibroBiologicsUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 15 Oct 2021 (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.
Fibroblasts have demonstrated potent immune modulatory and therapeutic activity in the experimental autoimmune encephalomyelitis (EAE) model of multiple sclerosis, as well as in other models of autoimmune and inflammatory diseases.
This study will assess primary safety and secondary efficacy endpoints of intravenous administration of 100 million tolerogenic fibroblasts to 5 patients with relapsing remitting MS resistant to interferon. While the safety of fibroblasts administered clinically is established, it is unknown whether these cells are effective in the treatment of multiple sclerosis (MS).
Our hypothesis is that the tolerogenic fibroblasts will be well-tolerated and meet our primary objective. In addition, The investigators are optimistic that they will see signs of efficacy based on the following: Neurological assessment of the MS functional composite assessment which comprises of EDSS, the expanded EDSS (Rating Neurologic Impairment in Multiple Sclerosis, the Scripps neurological rating scale (NRS), paced auditory serial addition test (PASAT), the nine-hole peg test, and 25-foot walking time, short-form 36 (SF-36) quality of life questionnaire and gadolinium-enhanced MRI scans of the brain and cervical spinal cord.
Detailed description
Fibroblasts have demonstrated potent immune modulatory and therapeutic activity in the experimental autoimmune encephalomyelitis (EAE) model of multiple sclerosis, as well as in other models of autoimmune and inflammatory diseases. Mechanistically, tolerogenic fibroblasts produce anti-inflammatory and immune modulatory factors, which appear to be therapeutic in the context of autoimmunity, including IL-10 and TGF-beta. Additionally, tolerogenic fibroblasts produce neurotrophic mediators that enhance myelin production and/or prevent neuronal apoptosis.
This study will assess primary safety and secondary efficacy endpoints of intravenous administration of 100 million tolerogenic fibroblasts to 5 patients with relapsing remitting MS resistant to interferon. While the safety of fibroblasts administered clinically is established, it is unknown whether these cells are effective in the treatment of multiple sclerosis (MS).
Research Hypothesis: Intravenous administration of 100 million tolerogenic fibroblasts will be well tolerated and induce a therapeutic effect in relapse remitting MS patients.
Rationale: The family of Mesenchymal Stem Cells (MSCs) is immune-modulatory, and bone marrow MSCs (BM-MSCs) have induced therapeutic responses in patients with MS [1]. Tolerogenic fibroblasts possess superior immune modulatory activity compared to BM-MSCs and adipose MSCs. The investigators, therefore, seek to perform a five-patient trial to assess the safety and signs of efficacy of this cell population in MS patients resistant to interferon.
The trial's primary objective is freedom from treatment-associated adverse events at 1, 2, 4, 8, and 16 weeks post-treatment. The study's secondary objective will be efficacy as assessed at baseline, weeks 2, 4, 8, and 16. The results will be quantified based on the following: Neurological assessment of the MS functional composite assessment, which comprises of EDSS, the expanded EDSS (Rating Neurologic Impairment in Multiple Sclerosis, the Scripps neurological rating scale (NRS), paced auditory serial addition test (PASAT), the nine-hole peg test, and 25-foot walking time, short-form 36 (SF-36) quality of life questionnaire and gadolinium-enhanced MRI scans of the brain and cervical spinal cord.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The proposed study will assess primary safety and secondary efficacy endpoints of allogeneic tolerogenic fibroblasts administered through Intravenous infusion at a single dose of 100 million cells to 5 patients with relapsing remitting MS resistant to interferon.
| Arm | Type | Receives |
|---|---|---|
| tolerogenic fibroblasts administered via intravenous infusion | Experimental | Biological: Tolerogenic FibroblastsA single dose of 100 million tolerogenic fibroblasts administered via intravenous infusion. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients willing to sign an informed consent and capable of understanding the features of this clinical trial.
- Willing to keep a weekly diary and undergo observation for four months
- Non-pregnant patients 18-55 years of age with MS according to the revised McDonald criteria and meeting the Possner criteria for clinically defined MS.
- EDSS scores of 2·0 to 5·5 points assessed at least three months after the last acute attack of MS.
Key exclusion criteria (14 listed)
- Patients with evidence of active proliferative retinopathy.
- Patients with poorly controlled diabetes mellitus (HbA1C > 8.5%).
- Patients with renal insufficiency (Creatinine > 2.5) or failure.
- Infection as evidenced by WBC count of >15,000 k/cumm and/or temperature >38C.
- History of organ transplant.
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 |
|---|---|---|
| Tolerogenic Fibroblastsadministrating single dose of 100 million tolerogenic fibroblasts via intravenous infusion | Biological | tolerogenic fibroblasts administered via intravenous infusion |
Primary outcome
Safety: Adverse even monitoring of subjects for 4 hours after infusion
Time frame: Monitoring during the Intravenous infusion of allogeneic tolerogenic fibroblasts, and continued for 4 hours after infusion
Monitor subjects for possible treatment-related acute immune symptoms or vascular occlusion symptoms during the administration of the allogeneic tolerogenic fibroblasts via intravenous infusion.
Safety: Complete Blood Count to monitor inflammation markers
Time frame: Day before infusion to establish a baseline, week 8, and week 16 after infusion
Complete Blood Count used to monitor inflammation markers included white blood cell (WBC), neutrophil (N), lymphocyte (L), neutrophil-lymphocyte ratio (NLR), mean platelet volume (MPV), and platelet-lymphocyte ratio. This safety test is to monitor subjects for inflammation during the course of the study, relating to the course of the disease, or allogeneic tolerogenic fibroblasts administered through Intravenous infusion
Safety: Serum chemistry to monitor impact on serum chemistry
Time frame: Day before infusion to establish a baseline, week 8, and week 16 after infusion
This test will measure the amount of certain substances in serum samples, including electrolytes (such as sodium, potassium, and chloride), fats, proteins, glucose (sugar), and enzymes. Blood chemistry tests give essential information about how well a person's kidneys, liver, and other organs are working. An abnormal amount of a substance in the blood can be a sign of disease or a side effect of treatment. Blood chemistry tests help diagnose and monitor many conditions before, during, and after treatment. Also called blood chemistry study.
Safety: 12-lead Electrocardiogram (ECG) to monitor cardiovascular health
Time frame: Day before infusion to establish a baseline, week 8, and week 16 after infusion
A 12-lead electrocardiogram will be used to monitor the baseline cardiovascular health of the participants and continue to monitor their cardiovascular health during the course of the study measuring heart rate, blood pressure, ventricular rate, PR interval, RP interval, QRS interval, and GT interval. This safety test is to monitor the subjects for cardiac events related to the course of the disease, or allogeneic tolerogenic fibroblasts administered through Intravenous infusion
5 secondary outcomes
Efficacy: Expanded Disability Status Scale (EDSS) to quantify disability scale and monitors changes
Time frame: Day before infusion to establish a baseline, week 8, and week 16 after infusion
Efficacy: Paced Auditory Serial Addition Test (PASAT) to measure cognitive function and processing speed
Time frame: Day before infusion to establish a baseline, week 8, and week 16 after infusion
Efficacy: Nine-Hole Peg Test to measure and quantify upper extermity function
Time frame: Day before infusion to establish a baseline, week 8, and week 16 after infusion
Efficacy: Timed 25-Foot Walk Test to quantify mobility and leg function
Time frame: Day before infusion to establish a baseline, week 8, and week 16 after infusion
Efficacy: Gadolinium Enhanced MRI to detect demyelinated areas of the nerves
Time frame: Day before infusion to establish a baseline, and week 16 after infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Background: PubMed 22236384Connick P, Kolappan M, Crawley C, Webber DJ, Patani R, Michell AW, Du MQ, Luan SL, Altmann DR, Thompson AJ, Compston A, Scott MA, Miller DH, Chandran S. Autologous mesenchymal stem cells for the treatment of secondary progressive multiple sclerosis: an open-label phase 2a proof-of-concept study. Lancet Neurol. 2012 Feb;11(2):150-6. doi: 10.1016/S1474-4422(11)70305-2. Epub 2012 Jan 10.
- Background: PubMed 16702830Kantarci O, Wingerchuk D. Epidemiology and natural history of multiple sclerosis: new insights. Curr Opin Neurol. 2006 Jun;19(3):248-54. doi: 10.1097/01.wco.0000227033.47458.82.
- Background: PubMed 23363936Evans C, Beland SG, Kulaga S, Wolfson C, Kingwell E, Marriott J, Koch M, Makhani N, Morrow S, Fisk J, Dykeman J, Jette N, Pringsheim T, Marrie RA. Incidence and prevalence of multiple sclerosis in the Americas: a systematic review. Neuroepidemiology. 2013;40(3):195-210. doi: 10.1159/000342779. Epub 2013 Jan 24.
- Background: PubMed 28367411Ghasemi N, Razavi S, Nikzad E. Multiple Sclerosis: Pathogenesis, Symptoms, Diagnoses and Cell-Based Therapy. Cell J. 2017 Apr-Jun;19(1):1-10. doi: 10.22074/cellj.2016.4867. Epub 2016 Dec 21.
- Background: PubMed 8872892Navikas V, Link H. Review: cytokines and the pathogenesis of multiple sclerosis. J Neurosci Res. 1996 Aug 15;45(4):322-33. doi: 10.1002/(SICI)1097-4547(19960815)45:43.0.CO;2-B.
- Background: PubMed 26019190Marrie RA, Elliott L, Marriott J, Cossoy M, Blanchard J, Leung S, Yu N. Effect of comorbidity on mortality in multiple sclerosis. Neurology. 2015 Jul 21;85(3):240-7. doi: 10.1212/WNL.0000000000001718. Epub 2015 May 27.
- Background: PubMed 21179614Goldman MD, Motl RW, Rudick RA. Possible clinical outcome measures for clinical trials in patients with multiple sclerosis. Ther Adv Neurol Disord. 2010 Jul;3(4):229-39. doi: 10.1177/1756285610374117.
- Background: PubMed 14313512SCHUMACHER GA, BEEBE G, KIBLER RF, KURLAND LT, KURTZKE JF, MCDOWELL F, NAGLER B, SIBLEY WA, TOURTELLOTTE WW, WILLMON TL. PROBLEMS OF EXPERIMENTAL TRIALS OF THERAPY IN MULTIPLE SCLEROSIS: REPORT BY THE PANEL ON THE EVALUATION OF EXPERIMENTAL TRIALS OF THERAPY IN MULTIPLE SCLEROSIS. Ann N Y Acad Sci. 1965 Mar 31;122:552-68. doi: 10.1111/j.1749-6632.1965.tb20235.x. No abstract available.
- Background: PubMed 20421572Polman CH, Rudick RA. The multiple sclerosis functional composite: a clinically meaningful measure of disability. Neurology. 2010 Apr 27;74 Suppl 3:S8-15. doi: 10.1212/WNL.0b013e3181dbb571.
- Background: PubMed 23911232Rodgers JM, Robinson AP, Miller SD. Strategies for protecting oligodendrocytes and enhancing remyelination in multiple sclerosis. Discov Med. 2013 Aug;16(86):53-63.
- Background: PubMed 27411042Ernstsson O, Gyllensten H, Alexanderson K, Tinghog P, Friberg E, Norlund A. Cost of Illness of Multiple Sclerosis - A Systematic Review. PLoS One. 2016 Jul 13;11(7):e0159129. doi: 10.1371/journal.pone.0159129. eCollection 2016.
- Background: PubMed 25911108Hartung DM, Bourdette DN, Ahmed SM, Whitham RH. The cost of multiple sclerosis drugs in the US and the pharmaceutical industry: Too big to fail? Neurology. 2015 May 26;84(21):2185-92. doi: 10.1212/WNL.0000000000001608. Epub 2015 Apr 24.
- EDSS descriptionLink provided by the sponsor.
- Multiple Sclerosis overviewLink provided by the sponsor.
- Diagnosing Multiple Sclerosis and Evaluating Disease ActivityLink provided by the sponsor.
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Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
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.
Hamid Khoja, Ph.D. study director
FibroBiologics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tolerogenic Fibroblasts in people with Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis, run by FibroBiologics at 1 site in Mexico.
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 4 inclusion and 14 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: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Adverse even monitoring of subjects for 4 hours after infusion (time frame: Monitoring during the Intravenous infusion of allogeneic tolerogenic fibroblasts, and continued for 4 hours after infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05080270, which also lists 17 linked publications.
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 22 Oct 2021.