NCT07542067CompletedPhase 1/2

Infusion of Allogeneic Stromal Mesenchymal Stem Cells From Wharton´s Jelly in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmonary Involvement to Treatment

Source: ClinicalTrials.gov · Last updated 21 Apr 2026

Brief summary (registry, in English)

Progressive SSc is an entity with limited therapeutic alternatives and a survival rate of less than 45% within the first 3 to 5 years. The disease causes severe limitations in quality of life, ranging from functional impairment to depression. Up to 20% of patients become refractory to conventional treatment with disease-modifying anti-rheumatic drugs (DMARDs) and cyclophosphamide therapy. This condition favors progression to visceral involvement, including gastrointestinal, pulmonary, and pulmonary hypertension manifestations. The latter, considered a poor prognostic factor, increases mortality in this patient population and drastically affects quality of life. For this reason, different therapeutic options have been considered, including cell transplantation and stem cell use. Among the options studied to date are stromal mesenchymal cells derived from Wharton's jelly. These cells have been administered via intravenous infusion or direct application in various disease scenarios, ranging from vascular involvement to interstitial lung disease and pulmonary hypertension, with promising results in terms of clinical progression, quality of life improvement, and prognostic indices. This therapy has demonstrated a favorable safety profile at the time of administration and a low rate of adverse events, with self-limiting fever being the most frequent event. Based on the above and considering the possibility of offering patients without therapeutic alternatives for the disease, in addition to palliative options, an intravenous infusion of stromal mesenchymal stem cells derived from Wharton's jelly is proposed for three patients with progressive SSc refractory to conventional therapy, with pulmonary involvement due to pulmonary hypertension. Under this premise, the research question posed in this study is: What are the effects of the infusion of allogeneic mesenchymal stromal cells derived from Wharton's jelly in patients with systemic sclerosis refractory to conventional treatment with methotrexate or cyclophosphamide, in a population of three patients with severe pulmonary involvement due to pulmonary hypertension?

Status (registry): Completed
Phase (registry): Phase 1/2
Study type: Interventional
Enrollment: 1 (actual)
First submitted: 20 May 2025
Start date: 15 May 2024
Primary completion date: 30 Jun 2025
Lead sponsor: Fundación Neumologica Colombiana
Diseases: Systemic sclerosis (scleroderma), Pulmonary arterial hypertension, High blood pressure
NCT number: NCT07542067

What you commit to

Study type: Interventional · Phase 1/2
Participants enrolled: 1
From 15 May 2024 to the primary completion date, 30 Jun 2025
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Chronic atrial fibrillation requiring oral anticoagulant therapy;
Active neoplasia or concomitant myelodysplasia, antecedent of neoplasia.

Other illness

Pulmonary artery systolic pressure (PASP) \>75mmHg (on echocardiography or after right heart catheterization);
- \- Theorical DLCO \<30%
Clinical sign of a congestive heart failure refractory ;
Uncontrolled ventricular arrhythmia;
Psychiatric disorders, including drug taking and alcohol abuse.
Uncontrolled systemic hypertension.
Uncontrolled acute or chronic infection, HIV1, 2 or HTLV-1, 2seropositivity.
Chronic hepatitis B or C active.
Significant exposure to bleomycin, toxic oils, vinyl chloride, trichloroethylene or silica; eosinophilia-myalgia syndrome, eosinophilia fasciitis.

Lab values

Calculated creatinine clearance \<30 ml/mn/m2
Left ventricular ejection fraction \<35% at myocardial scintigraphy or echocardiography;
Hepatic impairment defined as a persistent increase in transaminases or bilirubin to 3 times normal.
Bone marrow failure defined by neutropenia \<0.5 x 109 / L, thrombocytopenia \<50 x 109 / L, anemia \<8 g / dL, CD4 lymphopenia \<200 x 106 / L.

Other

Pregnancy or absence of appropriate contraception throughout the study.
Pericardial effusion with hemodynamic compromise assessed by echocardiography.
Risk of poor patient compliance

Who the study is looking for

Age\> 18 years and \<65 years.
Established diagnosis of systemic sclerosis according to the criteria of the American College of Rheumatology
SSc of poor prognosis, involving life-threatening severe visceral involvement (cardiac or pulmonary hypertension ), lack of response to conventional immunosuppressive therapy used in severe forms of the disease according to the European recommendations of EUSTAR and EBMT, relying on high doses of IV cyclophosphamide (either in monthly bolus for at least six months); or SSc with life-threatening pulmonary hypertension. Patients may or may not have pulmonary fibrosis.
Signed informed consent.
Presence of a consenting MSC donor
Affiliation to social security.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Clinica Universidad de La Sabana Coordinator of this site? Confirm its status	Bogotá	Colombia	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.