Multiple SclerosisNCT06228781
Autologous Hematopoietic Stem Cell Transplantation for Refractory Multiple Sclerosis
A study testing Autologous haemopoietic stem cell transplantation in people with Multiple Sclerosis, run by Tianjin Medical University General Hospital.
Trial summary
Autologous hematopoietic stem cell transplantation (aHSCT) is the only treatment for refractory autoimmune diseases capable of inducing long-term, drug-free and asymptomatic remission. Over the past two decades, aHSCT has been used to treat inflammatory autoimmune disease of the CNS. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Autologous haemopoietic stem cell transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years;
- Diagnosed multiple sclerosis with relapses or progression and sustained accumulated impairment by a neurologist expert in the field;
- EDSS score of 3-6 (including 3 and 6);
- EDSS cerebellar functional score ≥ 3 or EDSS pyramidal functional score ≥3；
- Evidence of current disease activity;
- If a patient has previously received a cytotoxic agent (mitoxantrone, cyclophosphamide etc.) they must have normal bone marrow morphology and cytogenetics before being considered eligible for this study ;
- No evidence of hepatic inflammation or fibrosis;
Who cannot join
- Patients with evidence of myelodysplasia or other non-autoimmune cytopenia;
- Patients having received a cytotoxic agent within one month of enrolling in this study;
- Patient with any active or chronic infection (herpes simplex virus, varicella-zoster virus, cytomegalovirus, EB virus, human immunodeficiency virus, hepatitis virus, syphilis, etc.);
- Patients having received a cytotoxic agent within one month of enrolling in this study;
- Patients with a malignant tumor currently or within the last 5 years;
- Patients with cardiac, renal, pulmonary, hepatic or other organ impairment;
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- Patients whose life expectancy is severely limited by another conditions;
- Pregnancy or risk of pregnancy;
- Patients unable to give written informed consent in accordance with research ethics board guidelines.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Autologous hematopoietic stem cell transplantation (aHSCT) is the only treatment for refractory autoimmune diseases capable of inducing long-term, drug-free and asymptomatic remission. Over the past two decades, aHSCT has been used to treat inflammatory autoimmune disease of the CNS. Patients with relapsing-remitting multiple sclerosis benefit from aHSCT treatment. However, a certain percentage of patients still experience recurrence 3 or 5 years after transplantation. Therefore, exploration of conditioning regimens will drive therapeutic advances in aHSCT in autoimmune diseases of the CNS.
- Conditions
- Multiple Sclerosis
- Being tested
- Autologous haemopoietic stem cell transplantation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous haemopoietic stem cell transplantationProcedure or surgery
Immuno-ablation and autologous CD34 selected hematopoietic stem cell transplantation (HSCT).
Stem cell mobilization with cyclophosphamide 2g/m2 and filgrastim 10 ug/kg/d x 5 day.
Stem cell collection with cobe cpectra stem cell purification with Miltenyi CliniMACS Stem cell transplant conditioning with busulphan 3.2 mg/kg ; fludarabine 30mg/m2 or cladribine 10mg ；cytarabine 1-2g/m2 or idarubicin 8mg/m2；cyclophosphamide 40mg/kg followed by CD34 selected autologous hematopoietic stem cell transplant.
| Study group | Role | What they receive |
|---|---|---|
| Hematopoietic Stem Cell Transplantation | Experimental | Patients will undergo stem cell transplantation for the treatment of refractory MS Receives: Procedure: Autologous haemopoietic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 year MS activity free survival
The events for the primary outcome are: clinical relapse, appearance of a new or Gd-enhancing lesion on MRI, or sustained progression of EDSS score.
Measured: 3 year follow-up post transplant
Secondary outcomes (6)
Time to MS treatment failure
Disease activity and disability will be assessed with clinical relapse, appearance of a new or Gd-enhancing lesion on MRI, or sustained progression of EDSS score and quality of life.
Measured: 3 years
Transplant related morbidity
Rate of transplant related events.
Measured: 3 years
Transplant related mortality
Rate of transplant related death.
Measured: 3 years
Immune reconstitution following transplant
Rate of immune reconstitution following transplant.
Measured: 3 years
Hematopoietic reconstitution following transplant
Rate of hematopoietic reconstitution following transplant.
Measured: 3 years
Imaging changes associated with the disease activity
Imaging changes include:
new or enlarging T2-weighted lesion count and new T1-weighted lesion count at all scans after baseline; T2-weighted lesion volume; Gd-enhanced lesion count and volume; and total volume of non-enhancing T1-weighted lesions on all MRI scans.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Liu, Tianjin Medical University General Hospital
- Investigators
- Qiang Liu, M.D.,Ph.D, Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228781
- Sponsor's protocol ID
- IRB2023-YX-233-01
- Status last verified
- Oct 2026
- First submitted
- 19 Jan 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Hematopoietic Stem Cell Transplantation for Refractory Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06228781
- Acronym / sponsor ID
- IRB2023-YX-233-01
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autologous hematopoietic stem cell transplantation (aHSCT) is the only treatment for refractory autoimmune diseases capable of inducing long-term, drug-free and asymptomatic remission. Over the past two decades, aHSCT has been used to treat inflammatory autoimmune disease of the CNS. Patients with relapsing-remitting multiple sclerosis benefit from aHSCT treatment. However, a certain percentage of patients still experience recurrence 3 or 5 years after transplantation. Therefore, exploration of conditioning regimens will drive therapeutic advances in aHSCT in autoimmune diseases of the CNS.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hematopoietic Stem Cell Transplantation | Experimental | Procedure: Autologous haemopoietic stem cell transplantationPatients will undergo stem cell transplantation for the treatment of refractory MS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-60 years;
- Diagnosed multiple sclerosis with relapses or progression and sustained accumulated impairment by a neurologist expert in the field;
- EDSS score of 3-6 (including 3 and 6);
- EDSS cerebellar functional score ≥ 3 or EDSS pyramidal functional score ≥3；
- Evidence of current disease activity;
Key exclusion criteria (9 listed)
- Patients with evidence of myelodysplasia or other non-autoimmune cytopenia;
- Patients having received a cytotoxic agent within one month of enrolling in this study;
- Patient with any active or chronic infection (herpes simplex virus, varicella-zoster virus, cytomegalovirus, EB virus, human immunodeficiency virus, hepatitis virus, syphilis, etc.);
- Patients having received a cytotoxic agent within one month of enrolling in this study;
- Patients with a malignant tumor currently or within the last 5 years;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous haemopoietic stem cell transplantationImmuno-ablation and autologous CD34 selected hematopoietic stem cell transplantation (HSCT). Stem cell mobilization with cyclophosphamide 2g/m2 and filgrastim 10 ug/kg/d x 5 day. Stem cell collection with cobe cpectra stem cell purification with Miltenyi CliniMACS Stem cell transplant conditioning with busulphan 3.2 mg/kg ; fludarabine 30mg/m2 or cladribine 10mg ；cytarabine 1-2g/m2 or idarubicin 8mg/m2；cyclophosphamide 40mg/kg followed by CD34 selected autologous hematopoietic stem cell transplant. | Procedure or surgery | Hematopoietic Stem Cell Transplantation |
Primary outcome
3 year MS activity free survival
Time frame: 3 year follow-up post transplant
The events for the primary outcome are: clinical relapse, appearance of a new or Gd-enhancing lesion on MRI, or sustained progression of EDSS score.
6 secondary outcomes
Time to MS treatment failure
Time frame: 3 years
Transplant related morbidity
Time frame: 3 years
Transplant related mortality
Time frame: 3 years
Immune reconstitution following transplant
Time frame: 3 years
Hematopoietic reconstitution following transplant
Time frame: 3 years
Imaging changes associated with the disease activity
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qiang Liu, M.D.,Ph.D principal investigator
Tianjin Medical University General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Autologous haemopoietic stem cell transplantation in people with Multiple Sclerosis, run by Tianjin Medical University General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiang Liu, M.D.,Ph.D (+86 15022439149, qliu@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 year MS activity free survival (time frame: 3 year follow-up post transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.