- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05016804
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell IV Infusion for Systemic Sclerosis
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Systemic Sclerosis
Study Overview
Detailed Description
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Systemic Sclerosis. Patients with Systemic Sclerosis will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.
For patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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St. John's, Antigua and Barbuda
- Recruiting
- Medical Surgical Associates Center
-
-
-
-
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Buenos Aires, Argentina
- Recruiting
- Center for Investigation in Tissue Engineering and Cellular Therapy
-
-
-
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N.L
-
San Pedro Garza García, N.L, Mexico
- Recruiting
- Medyca Bosques
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Systemic Sclerosis
- Understanding and willingness to sign a written informed consent document
Exclusion Criteria:
- Active infection
- Active cancer
- Chronic multisystem organ failure
- Pregnancy
- Clinically significant Abnormalities on pre-treatment laboratory evaluation
- Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
- Continued drug abuse
- Pre-menopausal women not using contraception
- Previous organ transplant
- Hypersensitivity to sulfur
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
Single intravenous infusion of 100 million cells
|
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety (adverse events)
Time Frame: Four year follow-up
|
Clinical monitoring of possible adverse events or complications
|
Four year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy: skin score
Time Frame: Four year follow-up
|
It will be completed for each follow up point.
|
Four year follow-up
|
Efficacy: Forced vital capacity (FVC)
Time Frame: Four year follow-up
|
It will be completed for each follow up point.
|
Four year follow-up
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Kaldas M, Khanna PP, Furst DE, Clements PJ, Kee Wong W, Seibold JR, Postlethwaite AE, Khanna D; investigators of the human recombinant relaxin and oral bovine collagen clinical trials. Sensitivity to change of the modified Rodnan skin score in diffuse systemic sclerosis--assessment of individual body sites in two large randomized controlled trials. Rheumatology (Oxford). 2009 Sep;48(9):1143-6. doi: 10.1093/rheumatology/kep202. Epub 2009 Jul 14.
- Granel B, Daumas A, Jouve E, Harle JR, Nguyen PS, Chabannon C, Colavolpe N, Reynier JC, Truillet R, Mallet S, Baiada A, Casanova D, Giraudo L, Arnaud L, Veran J, Sabatier F, Magalon G. Safety, tolerability and potential efficacy of injection of autologous adipose-derived stromal vascular fraction in the fingers of patients with systemic sclerosis: an open-label phase I trial. Ann Rheum Dis. 2015 Dec;74(12):2175-82. doi: 10.1136/annrheumdis-2014-205681. Epub 2014 Aug 11.
- Del Papa N, Di Luca G, Andracco R, Zaccara E, Maglione W, Pignataro F, Minniti A, Vitali C. Regional grafting of autologous adipose tissue is effective in inducing prompt healing of indolent digital ulcers in patients with systemic sclerosis: results of a monocentric randomized controlled study. Arthritis Res Ther. 2019 Jan 7;21(1):7. doi: 10.1186/s13075-018-1792-8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SC-10-ATG-12-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Systemic Sclerosis
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Horizon Pharma Ireland, Ltd., Dublin IrelandEnrolling by invitationDiffuse Cutaneous Systemic Sclerosis | Sclerosis, SystemicKorea, Republic of, France, United States, Spain, Mexico, Japan, Argentina, Greece, Israel
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Michael M. PhamTerminatedSystemic Sclerosis | Scleroderma, Systemic | Scleroderma, Diffuse | Diffuse Cutaneous Systemic Sclerosis | Interstitial Lung Disease | Scleroderma | Systemic Sclerosis, Diffuse | Diffuse Systemic Sclerosis | Pulmonary Fibrosis Interstitial | Diffuse Scleroderma | Diffuse Cutaneous Scleroderma | Progressive Systemic... and other conditionsUnited States
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Horizon Therapeutics Ireland DACRecruitingDiffuse Cutaneous Systemic Sclerosis | Sclerosis, SystemicNetherlands, Spain, Germany, United States, Japan, France, Italy, Korea, Republic of, Portugal, Israel, Greece, Argentina, Austria, Mexico, Poland, Switzerland, United Kingdom, Romania, Chile
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University of ManchesterCompletedEarly Diffuse Cutaneous Systemic Sclerosis
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Fred Hutchinson Cancer CenterNational Institute of Allergy and Infectious Diseases (NIAID)CompletedSystemic Scleroderma | Severe Systemic SclerosisUnited States
-
Kadmon, a Sanofi CompanyTerminatedDiffuse Cutaneous Systemic Sclerosis | System; SclerosisUnited States
-
Boston UniversityCompleted
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Federal University of São PauloUnknown
-
University Hospital, Strasbourg, FranceRecruitingJuvenile Systemic SclerosisFrance
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