Rheumatoid ArthritisPhase 1NCT05003934
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion and Intra-Articular Injection for RA
A Phase 1 study testing cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells in people with Rheumatoid Arthritis, run by The Foundation for Orthopaedics and Regenerative Medicine at 2 sites in 2 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Nov 2021to Sep 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Rheumatoid Arthritis
- Understanding and willingness to sign a written informed consent document
Who cannot join
- 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.
Show all 10Show fewer
- Continued drug abuse
- Pre-menopausal women not using contraception
- Previous organ transplant
- Hypersensitivity to sulfur
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Prodromos Stem Cell Institute
Naples, Florida, 34102
Chadwick Prodromos, MD, 847-699-6810 ext. 202, care@thepsci.com
Greece1 site, 1 recruiting
- Recruiting
Prodromos Stem Cell Institute
Athens
Chadwick Prodromos, MD, 847-699-6810 ext. 202, care@thepsci.com
About this study
Official title: 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
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
Read the detailed description
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Rheumatoid Arthritis (RA). 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. 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cellsBiological
cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Single intravenous infusion and intra-articular injection Receives: Biological: cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (adverse events)
Clinical monitoring of possible adverse events or complications
Measured: Four year follow-up
Secondary outcomes (2)
Efficacy: the 28-joint disease activity score (DAS 28)
DAS 28 is used to determine the disease activity for RA. It will be completed for each follow up point.
Measured: Four year follow-up
Efficacy: visual analog scale (VAS)
VAS is a scale that is used to measure pain. It will be completed for each follow up point.
Measured: Four year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start7 Nov 2021
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Foundation for Orthopaedics and Regenerative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chadwick Prodromos, MD, Principal investigator, The Foundation for Orthopaedics and Regenerative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003934
- Sponsor's protocol ID
- SC-8-ATG-10-03
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen J, Aletaha D, van Riel PL. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis. 2009 Jun;68(6):954-60. doi: 10.1136/ard.2007.084459. Epub 2008 May 19.
PubMed 18490431Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
PubMed 30211382Wang L, Huang S, Li S, Li M, Shi J, Bai W, Wang Q, Zheng L, Liu Y. Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cell Therapy for Rheumatoid Arthritis Patients: A Prospective Phase I/II Study. Drug Des Devel Ther. 2019 Dec 19;13:4331-4340. doi: 10.2147/DDDT.S225613. eCollection 2019.
PubMed 31908418Ghoryani M, Shariati-Sarabi Z, Tavakkol-Afshari J, Ghasemi A, Poursamimi J, Mohammadi M. Amelioration of clinical symptoms of patients with refractory rheumatoid arthritis following treatment with autologous bone marrow-derived mesenchymal stem cells: A successful clinical trial in Iran. Biomed Pharmacother. 2019 Jan;109:1834-1840. doi: 10.1016/j.biopha.2018.11.056. Epub 2018 Nov 26.
PubMed 30551438