Allogeneic Stem Cell Transplantation for the Treatment of Multiple Sclerosis

NCT00497952 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: ICT-13080-122206
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this research study is to establish chimerism with the goal to halt disease progression in patients with Multiple Sclerosis.

Conditions

Multiple Sclerosis

Keywords

Relapsing-remitting multiple sclerosis; Marrow/Stem cell transplant

Outcome Measures

Primary Outcomes (1)

• Stem cell engraftment

  One month to three years

Secondary Outcomes (1)

• Disease remission

  3 Years

Study Arms (1)

Multiple Sclerosis Patients

EXPERIMENTAL

Recipients treated with a hematopoetic stem cell infusion from a living donor

Biological: hematopoetic stem cell infusion

Interventions

hematopoetic stem cell infusion BIOLOGICAL

Enriched hematopoietic stem cell infusion

Multiple Sclerosis Patients

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinically definite MS according to the McDonald criteria
• Confirmed diagnosis of relapsing-remitting MS.
• Age between 18 and 55 years
• Extended Disability Status Score (EDSS) between 0 and 5.0
• Relapse within the last year or sustained disability progression of 1.0 for six months
• Treatment with high dose, high frequency Interferon-β therapy, or failure to tolerate Interferon-β therapy
• Diffusing capacity of the lung for carbon monoxide (DLCO)\> 50% (unless cleared by physician)
• Ejection fraction (EF) \> 40% (unless cleared by cardiologist)
• Required initial laboratory data (obtained within 30 days prior to transplant, unless otherwise specified)
• HIV-1,2 antigen and antibody negative
• HBsAg negative (chronic hepatitis B carriers without clinical evidence of liver disease can be considered on an individual basis if it is determined that the added risk is justified by the prognosis and lack of treatment alternatives)
• Hepatitis C antibody negative (positive antibody allowed if antigen (RNA)-negative and no clinical evidence of cirrhosis)
• Cytomegalovirus (CMV), hepatitis B, Human T-lymphotropic virus (HTLV)-1,2, Epstein-Barr virus (EBV), and Herpes antibody status known
• Pregnancy test negative (women of childbearing potential only)
• No life-threatening organ dysfunction.

You may not qualify if:

• Women who are of child bearing potential must have a negative pregnancy test (serum pregnancy test - human chorionic gonadotrophin (HCG)) within 48 hours of initiating total body irradiation and agree to use reliable contraception for 1 year following transplant.
• Concomitant severe diseases (respiratory, renal, liver, cardiac failures, psychiatric disorders, neoplasms)
• Recurrent urinary, pulmonary infections.
• Active bacterial, viral, or fungal infection
• Active peptic ulcer disease
• Previous treatments with total lymphoid irradiation or total body irradiation
• Interferon-neutralizing antibody positive with a titer greater than 20
• Relapse in the month preceding enrollment
• Poor compliance

Sponsors & Collaborators

• Talaris Therapeutics Inc.: lead

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Suzanne T Ildstad, MD

  Talaris Therapeutics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: July 6, 2007
• First Posted: July 9, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 12, 2023

Record last verified: 2023-10