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Ischemic StrokePhase 1/2ABMSC-ISNCT06997939

Autologous Bone Marrow Mesenchymal Stem Cell Therapy for Ischemic Stroke

A Phase 1/2 study testing ABMSC in people with Ischemic Stroke, run by Affiliated Hospital of Nantong University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Stroke is a group of diseases mainly characterized by cerebral ischemia or hemorrhage, with a high fatality rate and disability rate. It has now become a major obstacle to social and economic development. Stem cells are a type of primitive cells with self-renewal, proliferation and differentiation potential. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Ischemic Stroke
What is being tested?
ABMSC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
1 Jun 2025to 31 May 2027
Phase
Phase 1/2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-65 years, both male and female
  • Confirmed diagnosis of ischemic stroke within 3-12 months before enrollment.
  • Moderate stroke with NIHSS score 5-12 at screening
  • Modified Rankin Scale (mRS) score 3-5 (moderate to severe disability)
  • Patient or legal guardian willing to provide written informed consent for treatment and study participation
  • Able to comply with medical history collection, data storage, and follow-up procedures

Who cannot join

  • Patients with needle phobia or lumbar spine disease affecting bone marrow aspiration
  • Any acute illness at the time of screening
  • Severe disability or end-stage disease
  • Severe heart, liver, or kidney dysfunction
  • Pulmonary infection or severe systemic infection
  • History of severe allergic reactions
Show all 17Show fewer
  • Use of immunosuppressive drugs (e.g., steroids) within 3 months or vaccination within 6 months
  • Any organic lesions causing increased intracranial pressure
  • Current or past malignancy
  • Seropositive for HIV, syphilis, hepatitis B, hepatitis C, or other severe infectious diseases
  • Severe mental illness or impaired consciousness
  • Coagulopathy or ongoing anticoagulant therapy
  • Blood pressure ≥180/110 mmHg despite treatment
  • Poorly controlled diabetes with advanced complications and Pre-existing conditions affecting limb mobility (e.g., claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis)
  • Participation in another clinical trial within 3 months
  • Major surgery or trauma (including fractures) within 1 month
  • Any other condition deemed unsuitable for study participation by the investigator

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qiuhong Ji, MD, PhD contact

+8613962916293

jiqiuhong@ntu.edu.cn

China1 site

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226000

    Qiuhong Ji, MD, PhD, +8613962916293, jiqiuhong@ntu.edu.cn

    Tian Xu, MD, PhD, +8618251313276, xutian84@163.com

Other trials in China

About this study

Official title: A Clinical Trial of Autologous Bone Marrow-Derived Mesenchymal Stem Cell Transplantation for Precision Therapy in Ischemic Stroke

Stroke is a group of diseases mainly characterized by cerebral ischemia or hemorrhage, with a high fatality rate and disability rate. It has now become a major obstacle to social and economic development. Stem cells are a type of primitive cells with self-renewal, proliferation and differentiation potential. Under certain conditions, they can differentiate into cells of various tissues and organs. They have now become one of the key research directions for the repair of functional disorders after ischemic stroke. Compared with other types of stem cells, bone marrow mesenchymal stem cells (BMSCs) have the advantages of being relatively easy to obtain with less tissue damage, convenient and rapid in vitro expansion and culture, and the ability to actively migrate to the lesion area after injection without the risk of canceration.

This study plans to recruit and screen 12 subjects with ischemic stroke, divided into three groups (Ommaya drug reservoir group, low-dose internal carotid artery transplantation group, and high-dose internal carotid artery transplantation group), with 4 subjects in each group, for a clinical study of ABMSCs treatment for functional disorders after ischemic stroke. In accordance with the established treatment protocol, bone marrow will be collected from subjects during the stable phase of their condition, and ABMSCs will be infused three times via Ommaya drug reservoir/internal carotid artery within 1-6 months after collection. The study will assess the improvement of motor function in patients and analyze the feasibility and effectiveness of this therapy, laying a solid foundation for future clinical applications.

Conditions
Ischemic Stroke
Being tested
ABMSC
Keywords
autologous, bone marrow mesenchymal stem cell, mRS, functional recovery, Carotid artery intervention, NIHSS
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABMSCBiological

    Autologous bone marrow-derived mesenchymal stem cells administered via Ommaya reservoir；2.0*10^7 cell/dose

  • ABMSCBiological

    Autologous bone marrow-derived mesenchymal stem cells via intra-arterial route；Low-dose group; 2.5*10^6 cell/dose

  • ABMSCBiological

    Autologous bone marrow-derived mesenchymal stem cells via intra-arterial route；High-dose group; 1.0*10^7 cell/dose

Study groups in NCT06997939
Study groupRoleWhat they receive
Ommaya Reservoir GroupExperimentalStem Cell via Ommaya；2*10^7 cells dose
Receives: Biological: ABMSC
Low-Dose intra-arterial transplantation groupExperimentalInternal carotid artery(ICA) transplantation；Low-dose; 2.5*10^6 cells dose
Receives: Biological: ABMSC
High-Dose intra-arterial transplantation groupExperimentalInternal carotid artery(ICA) transplantation；High-dose; 1.0*10^7 cells dose
Receives: Biological: ABMSC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events and serious adverse events

    To assess safety, the number of AEs or SAEs will be evaluated

    Measured: 3-7 days post each transplantation and 6-month follow-up

Secondary outcomes (9)

  1. National Institutes of Health Stroke Scale（NIHSS） score

    The changes during the treatment and observation period and follow-up period compared with those before treatment

    Measured: 3-7 days post each transplantation and 6-month follow-up

  2. Modified Rankin Scale(mRS) score

    The changes during the treatment, observation period and follow-up period compared with those before treatment

    Measured: 3-7 days post each transplantation and 6-month follow-up

  3. Modified Barthel Index

    The changes during the treatment, observation period and follow-up period compared with those before treatment

    Measured: 3-7 days post each transplantation and 6-month follow-up

  4. Fugl-Meyer Assessment

    The changes during the treatment, observation period and follow-up period compared with those before treatment

    Measured: 3-7 days post each transplantation and 6-month follow-up

  5. Fugl-Meyer Balance Assessment

    The changes during the treatment, observation period and follow-up period compared with those before treatment

    Measured: 3-7 days post each transplantation and 6-month follow-up

  6. 10-Meter Walk Test(10MWT) Time

    The changes during the treatment, observation period and follow-up period compared with those before treatment

    Measured: 3-7 days post each transplantation and 6-month follow-up

  7. Functional Ambulation Category(FAC)

    The changes during the treatment, observation period and follow-up period compared with those before treatment

    Measured: 3-7 days post each transplantation and 6-month follow-up

  8. Cerebral infarct volume changes on MRI

    The changes during the follow-up period compared with those before treatment

    Measured: 6-month follow-up

  9. Surface electromyography(sEMG) signal changes

    The changes during the treatment, observation period and follow-up period compared with those before treatment

    Measured: 3-7 days post each transplantation and 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-center, three-arm parallel randomized controlled trial: Group A (Ommaya reservoir delivery), Group B (low-dose intra-arterial transplantation), and Group C (High-dose intra-arterial transplantation), with double-blinding.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06997939
Sponsor's protocol ID
2025-G097
Acronym
ABMSC-IS
Status last verified
May 2025
First submitted
18 May 2025
Last updated
31 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ABMSC in people with Ischemic Stroke, run by Affiliated Hospital of Nantong University at 1 site in China.

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 6 inclusion and 17 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 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Qiuhong Ji, MD, PhD (+8613962916293, jiqiuhong@ntu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events and serious adverse events (time frame: 3-7 days post each transplantation and 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06997939.

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 31 May 2025.

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