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Autologous mesenchymal stem cell transplantation

Phase 1

Relapsing-Remitting Multiple Sclerosis | Monoclonal antibody | Neurology |Community Health Systems, Inc.|Last Updated: Mar 30, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Autologous mesenchymal stem cell transplantation · 1 trial · 3 indications

Phase 1 1
NCT00813969Autologous Mesenchymal Stem Cell (MSC) Transplantation in MSRelapsing-Remitting Multiple Sclerosis
COMPLETED24 Analytics
PHASE1COMPLETED
Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS
Relapsing-Remitting Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the feasibility of culturing MSCs, and infusion-related safety and tolerability of autologous MSC transplantation over one month in patients with relapsing forms of MS
1 month

Secondary Endpoints

To evaluate effects on MS disease activity measured by the number of Gd-enhancing brain MRI lesions
1 month
To evaluate safety and tolerability of autologous MSC transplantation over 6 months
6 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Autologous MSC transplantationEXPERIMENTAL -

Interventions

NameTypeDescription
Autologous mesenchymal stem cell transplantationBIOLOGICALA single IV infusion of up to 2 million cells per kg based on the MSC numbers achieved after culture expansion
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age 18 to 55, inclusive. * Diagnosis of MS * Relapsing form of MS (relapsing-remitting, secondary progressive, or progressive-relapsing course). * EDSS score 3.0-6.5, inclusive. (Must be able to walk) * Active disease during prior 24 months. * Documented evidence of involvemen...

Countries:United States
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Frequently asked questions about Autologous mesenchymal stem cell transplantation

What is Autologous mesenchymal stem cell transplantation used for?

Autologous mesenchymal stem cell transplantation is an investigational cell therapy being studied for Relapsing-Remitting Multiple Sclerosis. It is in Phase 1 clinical development and is not yet approved by the FDA. The therapy uses a patient's own mesenchymal stem cells, which are collected and then transplanted back into the patient.

Who is developing Autologous mesenchymal stem cell transplantation?

Autologous mesenchymal stem cell transplantation is being developed by Community Health Systems, Inc., which trades under the ticker CYH. The company is conducting clinical research on this investigational therapy for multiple sclerosis. The therapy is in Phase 1 development and remains investigational.

What phase is Autologous mesenchymal stem cell transplantation in?

Autologous mesenchymal stem cell transplantation is in Phase 1 clinical development. It is an investigational therapy for Relapsing-Remitting Multiple Sclerosis and has not been approved by the FDA. The Phase 1 trial has been completed, and the therapy is still in the early stages of clinical testing.

What clinical trials is Autologous mesenchymal stem cell transplantation in?

Autologous mesenchymal stem cell transplantation has one completed clinical trial, NCT00813969, titled "Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS." This Phase 1 study enrolled 24 participants in the United States and included patients with Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, and Progressive Relapsing Multiple Sclerosis.

Is Autologous mesenchymal stem cell transplantation FDA approved?

Autologous mesenchymal stem cell transplantation is not FDA approved. It is an investigational therapy currently in Phase 1 clinical development for Relapsing-Remitting Multiple Sclerosis. The therapy has completed a Phase 1 trial but has not yet received regulatory approval for commercial use.