RECRUITINGPhase 1INTERVENTIONAL
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
About This Trial
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Systemic Sclerosis
Who May Be Eligible (Plain English)
Who May Qualify:
- Diagnosis of Systemic Sclerosis
- Understanding and willingness to sign a written willing to sign a consent form document
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
BIOLOGICAL
AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Locations (2)
Medical Surgical Associates Center
St John's, Antigua and Barbuda
Center for Investigation in Tissue Engineering and Cellular Therapy
Buenos Aires, Argentina