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Stem Cell Therapy

Intrathecal MSC-NP injection for Multiple Sclerosis

Phase 2

Waitlist Available

Led By Saud A Sadiq, MD, FAAN

Research Sponsored by Tisch Multiple Sclerosis Research Center of New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 36 from first treatment or placebo

Awards & highlights

Study Summary

This trial will test whether multiple injections of a person's own stem cells can help treat progressive multiple sclerosis. Efficacy will be measured by disability outcomes.

Eligible Conditions

Multiple Sclerosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 36 from first treatment or placebo

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 36 from first treatment or placebo

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 36 from first treatment or placebo for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Expanded Disability Status Scale (EDSS) Plus

Secondary outcome measures

Bladder function

Multiple sclerosis functional composite (MSFC)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intrathecal MSC-NP injectionExperimental Treatment1 Intervention

Patients will receive six autologous stem cell injections through spinal taps every 2 months over a year.

Group II: Intrathecal saline injectionPlacebo Group1 Intervention

Patients will receive six placebo injections through spinal taps every 2 months over a year.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intrathecal MSC-NP injection

2018

Completed Phase 2

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Tisch Multiple Sclerosis Research Center of New YorkLead Sponsor

2 Previous Clinical Trials

20 Total Patients Enrolled

2 Trials studying Multiple Sclerosis

20 Patients Enrolled for Multiple Sclerosis

Saud A Sadiq, MD, FAANPrincipal InvestigatorTisch MS Research Center of New York

1 Previous Clinical Trials

1 Trials studying Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any participants being accepted for this research endeavor presently?

"The clinical trial hosted on clinicialtrials.gov is no longer accepting patients, as it was initially listed in September 2018 and last updated October 2022. However, there are still 549 other studies actively recruiting participants across the United States at this time."

Answered by AI

What potential risks could arise from an Intrathecal MSC-NP injection?

"Leveraging the data we have, our team at Power assigned a score of 2 to Intrathecal MSC-NP injection's safety. This rating is due to this being a Phase 2 trial and thus having only some evidence supporting its security, but no reports attesting to it efficacy."

Answered by AI

Does this medical research extend to octogenarians?

"This research is open to individuals between the age of consent and 65 years old."

Answered by AI

How may I go about joining this research endeavor?

"This clinical study is admitting around 50 people with multiple sclerosis who are between adolescence and the onset of old age."

Answered by AI

Who else is applying?

What state do they live in?

New York

Mississippi

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

What site did they apply to?

Tisch MS Research Center of New York

How many prior treatments have patients received?

Why did patients apply to this trial?

Ive been on Ocrevus since diagnosed in 2018. Unfortunately I am now using an aid to walk and am fearful of losing my ability altogether. I have 2 children and a wife. A young son who is 13 that I can't even stand long enough to play catch, never mind baseball or any sport for that matter. I am willing and desperately want to be part of this promising trial. I am 51 years old I want to be able to one day be able to hopefully walk my daughter down the aisle. My wife has been consciously looking for trials in our area. This could be the dream we have been hoping and praying for.

PatientReceived 1 prior treatment

Recent research and studies

EBioMedicineJournal

Phase I Trial of Intrathecal Mesenchymal Stem Cell-derived Neural Progenitors in Progressive Multiple Sclerosis

Harris, Violaine K., James Stark, Tamara Vyshkina, Leslie Blackshear, Gloria Joo, Valentina Stefanova, Gabriel Sara, and Saud A. Sadiq. 2018. “Phase I Trial of Intrathecal Mesenchymal Stem Cell-derived Neural Progenitors in Progressive Multiple Sclerosis”. Ebiomedicine. Elsevier BV. doi:10.1016/j.ebiom.2018.02.002.

EBioMedicineJournal

Phase I Trial of Intrathecal Mesenchymal Stem Cell-derived Neural Progenitors in Progressive Multiple Sclerosis

clinicaltrials.govStudy

Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis

2018. "Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03355365.