Health TrialsbyHealthPanel

Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients

ConditionsStrokeStroke, IschemicStroke; Sequelae
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-70
SponsorHokkaido University Hospital

About this trial

The goal of this clinical trial is to evaluate if autologous mesenchymal stem cell (HUNS001-01) transplantation therapy can provide neurological recovery in patients with chronic stage of stroke resulting in moderate to severe neurological sequelae. The main questions it aims to answer are:

Can HUNS001-01 intracerebral transplantation demonstrate improvement in the mRS of disability for 1 year after intervention? Can HUNS001-01 intracerebral transplantation can be performed without any adverse events for 1 year after intervention?

Participants will receive the below interventions.

* Screening for the eligibility to enroll the clinical trial (interview, blood test, imaging) * Harvest of platelet concentrates (PC) * Harvest of bone marrows (BM) * Receive intracerebral transplantation surgery of HUNS001-01 * Post-operative rehabilitation * Follow-up studies (until 1 year or termination of the trial)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 20 and 70 years

Clinical diagnosis of ischemic stroke between 6 months and 5 years ago

Ischemic area in the territory of unilateral interanal cerebral artery

Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage Ⅲ or IV

Disqualifiers

Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)"

Anaemia (Hg < 10·0 g/dL)

Thrombocytopaenia (platelet count < 100,000/mm3)

Severe heart disease (ischaemic heart disease, heart failure)

Trial design

Design model

Single group

Treatments tested in this trial

  • Stem cell Transplantation

    Drug

    Manufactured autologous mescenchymal stem cell (HUNS001-01) in our cell processing center will be injected into the brain, totally 4 x 10\^7 cells, in 2 brain sites.

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: Stem cell transplantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy of HUNS001-01 administration

The frequency of the improvement in mRS of disability by 1 or more from baseline

Time frame
one year

Secondary outcomes

1

Safety of HUNS001-01 administration

frequency of Adverse Event

Time frame
one year
2

Change in NIHSS examination

Mean improvement of NIHSS (0-42, higher score means worse outcome)

Time frame
one year
3

Change in FIM examination

Mean improvement of FIM (18-126, higher score means better outcome)

Time frame
one year
4

Change in Fugl-Myer examination

Mean improvement of Fugl-Myer (0-226, higher score means better outcome)

Time frame
one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hokkaido University Hospital

Lead sponsor

RAINBOW Inc.

Collaborator

Source ClinicalTrials.gov
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