Umbilical cord stem cells tested for rare lung condition
NCT ID NCT07542067
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a single intravenous infusion of stem cells from donated umbilical cord tissue in one person with severe scleroderma that had caused lung scarring and high blood pressure in the lungs. The goal was to see if the treatment could improve lung function, exercise ability, and quality of life. Because only one person took part and there was no comparison group, the results are very preliminary and cannot be generalized.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mesenchymal stem cells from donated umbilical cord tissue (Wharton's jelly)
- What this could lead to
- If this approach works, it could point toward a new treatment option for people with severe scleroderma that affects the lungs and has not responded to standard therapies.
- What could go wrong
- This was a very early, tiny study (only 1 participant) with no control group. The results may not apply to other patients, and the treatment may not work or could cause side effects like fever.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
1 person
The number who actually took part.
- Started
-
May 2024
- Finished
-
Aug 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * Pregnancy or absence of appropriate contraception throughout the study. * Pulmonary artery systolic pressure (PASP) \>75mmHg (on echocardiography or after right heart catheterization); \- Theorical DLCO \<30% * Calculated creatinine clearance \<30 ml/mn/m2 * Clinical sign of a congestive heart failure refractory ; * Left ventricular ejection fraction \<35% at myocardial scintigraphy or echocardiography; * Chronic atrial fibrillation requiring oral anticoagulant therapy; * Uncontrolled ventricular arrhythmia; * Pericardial effusion with hemodynamic compromise assessed by echocardiography. * Hepatic impairment defined as a persistent increase in transaminases or bilirubin to 3 times normal. * Psychiatric disorders, including drug taking and alcohol abuse. * Active neoplasia or concomitant myelodysplasia, antecedent of neoplasia. * 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. * 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. * Risk of poor patient compliance
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Clinica Universidad de La Sabana
Bogotá, Bogota D.C., 110131, Colombia
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