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Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion and Intra-Articular Injection for RA

Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion and Intra-Articular Injection for the Treatment of Rheumatoid Arthritis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions, Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients with RA will receive a single intravenous infusion and intra-articular injection of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe stem cell treatment is and how well it works for people with rheumatoid arthritis, a disease that causes swollen, painful joints. The cells come from a donor’s umbilical cord or placenta and are grown in a lab. They are given through a vein and by a shot into a joint.

This trial will study the safety and efficacy of intravenous infusion and intra-articular injection of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells for the treatment of Rheumatoid Arthritis

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a diagnosis of rheumatoid arthritis.
  • Understand the study and be willing to sign a form agreeing to take part.

Who can't join

  • Have an active infection or cancer.
  • Have long-term failure of several organs.
  • Are pregnant, or have not gone through menopause and are not using birth control.
  • Have abnormal lab test results before treatment that are medically important.
  • Have a health problem that the study doctor thinks could make taking part unsafe.
  • Have ongoing drug abuse.
  • Have had an organ transplant.
  • Are allergic to sulfur.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Diagnosis of Rheumatoid Arthritis * 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 sites (1)

FL