Tiny trial hopes blood filtering eases rare stiff person syndrome
NCT ID NCT06703333
First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This early pilot study will test the safety of a procedure called extracorporeal photopheresis (ECP) in just 3 adults with stiff person syndrome. ECP involves filtering a person's blood, treating it with light and a drug, then returning it to the body. The goal is to see if patients can tolerate the 18 sessions over 6 months without serious side effects. This is a safety-only trial, not designed to prove the treatment works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- extracorporeal photopheresis (ECP)
- What this could lead to
- If this treatment is safe, it could point toward a new way to manage stiff person syndrome symptoms.
- What could go wrong
- This is a very early, tiny pilot study with only 3 people. It is designed to test safety, not effectiveness, so it may not lead to any treatment change.
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
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Expected to start
-
Aug 2026
An estimate. Start dates often move.
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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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: * Documented history of classical SPS with serum and CSF anti-GAD antibodies. * Age ≥ 18 ≤ 75 years. * Weight ≥ 50 kg. * Hematocrit ≥ 30 % (with or without transfusion support). * Platelet count ≥ 100 x 10\^3/uL (with or without transfusion support). * Willingness to use at least one reliable method of birth control (e.g., abstinence, oral contraceptives, intrauterine devices, barrier method with spermicide, or surgical sterilization) throughout the study for all men and women of childbearing potential. * Willingness to participate in all study tests, visits, and procedures (including ECP), as outlined in the informed consent. * Adequate peripheral venous access to initiate ECP therapy. * The patient agrees to participate in the trial and signs the informed consent form. Exclusion Criteria: * Progressive encephalomyelitis with rigidity and myoclonus (PERM). * Paraneoplastic variants of SPS. * Concurrent diagnosis of a neurological condition that would interfere with the assessment of SPS. * Women who are pregnant and/or lactating. * Absolute medical contraindication to receive ECP. * Hypersensitivity or allergy to psoralen (methoxalen). * Hypersensitivity or allergy to heparin. * Previous history of heparin-induced thrombocytopenia. * Aphakia or photosensitive disease (systemic lupus erythematosus, porphyrias, etc.). * Laboratory evidence of any of the following: * Mononuclear cell (MNC) count \<2.0 x 10\^3 cells/uL. * Serum transaminase levels \> x 2 UNL. * Estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73 m2. * Evidence of known infection with human immunodeficiency virus (HIV) or hepatitis B. * Uncontrolled infection requiring treatment at study entry. * Use of any investigational drug/treatment at the time of enrollment or within the previous 60 days, or five elimination half-lives, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer. * Previous history of skin cancer, leukemia / lymphoma / myeloma, or bone marrow transplant. * Any other disease or condition which, in the opinion of the investigator, could interfere with participation according to the study Protocol, or with the ability of the patients to cooperate and comply with study procedures. * Inability to provide informed consent.
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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
-
Abu Dhabi Stem Cells Center
Abu Dhabi, 4600, United Arab Emirates
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