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AzTrials

Parkinson Disease (PD)Phase 1NCT07572071

Safety and Feasibility of Bilateral Striatal Transplantation of DopaCell in Parkinson's Disease

A Phase 1 study testing Dopacell, Immunosuppressive Regimen and Customized microinjection device in people with Parkinson Disease (PD), run by Royan Institute at 3 sites in Iran.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Dopason is a phase I, open-label, multicenter, single-arm clinical trial designed to evaluate the safety and feasibility of intraputaminal transplantation of human embryonic stem cell-derived dopaminergic progenitor cells (DopaCells) in patients with moderately severe Parkinson's disease. Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Parkinson Disease (PD)
What is being tested?
Dopacell, Immunosuppressive Regimen and Customized microinjection device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
3 sitesIran
Study dates
1 Aug 2025to 1 Aug 2030
Phase
Phase 1
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 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 30-70 years
  • Diagnosis of PD: MDS clinical Diagnostic Criteria for Parkinson's disease
  • The disease duration more than 5 years
  • Moderate Parkinson's disease, defined as a Hoehn and Yahr stage of 2 or 3 during the OFF period.
  • The patient is receiving oral pharmacological therapy, and in the opinion of the Principal Investigator, the patient's symptoms remain inadequately controlled despite optimal medical management, or the patient is experiencing adverse effects related to their current treatment
  • No history or only mild levodopa-induced dyskinesia, defined as a score of 2 or less on the UDysRS scale in any body region during the ON state.
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  • The patient demonstrates a clinically meaningful response to a therapeutic dose of levodopa, as determined by the Principal Clinical Investigator or a trained specialist under the supervision of the Principal Investigator.
  • The performance of different organs based on laboratory evaluations:
  • Number of neutrophils ≥2000 / microliter
  • Platelet count ≥100,000 / microliter
  • AST / ALT: less than or equal to three times the maximum normal value at the intervention site
  • Total bilirubin less than or equal to 1.5 times the maximum normal amount at the intervention site
  • eGFR * rate: greater than or equal to 60 ml / min / 1.73 m2 * eGFR (mL / min / 1.73 m2) = 194 X Cr ^ -1.094 X age ^ -0.287 (X 0.739 for females)
  • Informed consent

Who cannot join

  • The abnormal function of immune system
  • The symptomatic brain injuries (brain atrophy, cerebral Infarct, trauma, vascular malformation) confirmed by brain MRI
  • Markedly reduced or normal signal in the ventral striatum on TRO-DaT SPECT imaging.
  • Any abnormal findings on brain MRI.
  • Positive GBA mutation test.
  • Diagnosis of dementia based on a MoCA score < 24.
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  • The abnormality of thrombotic system or high risk of bleeding
  • Positive for any of the following viral markers or active infections: HBsAg, HBsAb, HBcAb, anti-HIV antibodies, anti-HTLV-1\&2 antibodies, active hepatitis C infection, syphilis, or active CMV, VZV, EBV, or COVID-19 infection.
  • Impossibility of MRI imaging for patients with metal in the body, pacemaker in the body, claustrophobia, with artificial heart valves that are incompatible with MRI or body weight is not within the tolerable range for MRI.
  • Patients with contraindications to the study drug: Tacrolimus, Prednisolone, Basiliximab, Cotrimoxazole, MRI contrast agent.
  • Patients undergoing other cell transplants, including embryonic stem cell-derived dopaminergic progenitor cells.
  • Patients with a history of PD at the same time and concurrent: Malignant neoplasm, epilepsy, cerebral hemorrhage or a positive history
  • Psychiatric disorders confirmed by a psychiatrist, including major depression, bipolar disorder, or schizophrenia, that are uncontrolled or treatment resistant.
  • Patients with intellectual disability who, in the judgment of a psychiatrist, are unable to fully comprehend the study requirements.
  • History of pallidotomy, thalamotomy, or deep brain stimulation (DBS).
  • Patients considered high-risk candidates for surgery, particularly neurosurgery or DBS implantation, due to significant cardiovascular, pulmonary, or other systemic comorbidities identified during preoperative evaluation.
  • Patients who have a history of taking the following in the three months prior to enrollment: Immunosuppressant, antipsychotic drug, anticonvulsant drugs or anticoagulant therapy (if discontinuation or perioperative adjustment is not feasible), botulinum toxin (within 6 months), phenol injections, or other treatments for dystonia or muscle spasm
  • History of Apomorphine use
  • History of chronic alcohol use or illicit drug abuse.
  • Patients who are pregnant, lactating, or people who did not avoid pregnancy during the study.
  • Patients who, according to the researchers' opinions, are not suitable for safe study.

Trial locations and contacts

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

Sarvenaz Salahi, MD contact

021-23562000

salahi13639@gmail.com

Iran3 sites, 3 recruiting

  • Shiraz University of Medical Sciences

    Shiraz

    Sarvenaz Salahi, MD, 021-2356200, salahi13639@gmail.com

    Recruiting

  • Iran University of Medical Sciences

    Tehran

    Sarvenaz Salahi, MD, 021-2356200, salahi13639@gmail.com

    Recruiting

  • Royan Institute

    Tehran

    Sarvenaz Salahi, MD, 021-2356200, salahi13639@gmail.com

    Recruiting

Other trials in Iran

About this study

Official title: Evaluation of the Safety and Feasibility of a Single Transplantation of 10 Million Human Embryonic Stem Cell-Derived Dopaminergic Progenitor Cells Into the Bilateral Striatum of Patients With Moderately Severe Parkinson's Disease: a Multicenter, Open-label, Single-arm Phase I Clinical Trial

Dopason is a phase I, open-label, multicenter, single-arm clinical trial designed to evaluate the safety and feasibility of intraputaminal transplantation of human embryonic stem cell-derived dopaminergic progenitor cells (DopaCells) in patients with moderately severe Parkinson's disease.

Read the detailed description

During this trial phase, a total of six participants will be included and distributed between two clinical centers. Each participant will undergo one standardized surgical procedure consisting of bilateral stereotactic intraputaminal transplantation of approximately 10 × 10⁶ cells in total (about 5 × 10⁶ cells per putamen), aiming to achieve an estimated survival of 200,000 neurons. All procedures will be performed using the same surgical delivery system and an almost identical operative protocol across both sites to ensure procedural consistency. After transplantation, patients will receive immunosuppressive therapy for a duration of one year and will be systematically followed for study outcomes for at least 12 months.

Being tested
Dopacell, Immunosuppressive Regimen, Customized microinjection device
Keywords
Parkinson's disease, Dopaminergic progenitor cell transplantation, Intrastriatal
Medical subject headings
Parkinson Disease

What participants receive

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

  • DopacellBiological

    DopaCells are dopamine-producing progenitor cells generated from human embryonic stem cells through differentiation under GMP-compliant conditions.

  • Immunosuppressive RegimenDrug

    Basiliximab, Tacrolimus, Prednisolone

  • Customized microinjection deviceDevice

    For intraputaminal delivery of DopaCell

Study groups in NCT07572071
Study groupRoleWhat they receive
TransplantationExperimentalExperimental: DopaCell Biological: DopaCell, 5 million cells per putamen Immunosuppressive Regimen: Basiliximab, Tacrolimus, Prednisolone Device: Customized microinjection device
Receives: Biological: Dopacell; Drug: Immunosuppressive Regimen; Device: Customized microinjection device

What is being measured

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

  1. Safety

    Incidence and severity of treatment-emergent adverse events (TEAEs)

    Measured: Baseline to 12 Months Post-Transplant

  2. Safety

    Evidence of any post-transplantation anatomical changes at the transplant site suggestive of tumor formation, as assessed by MRI imaging.

    Measured: Baseline to 12 Months Post-Transplant

  3. Feasibility

    Successful completion of a single-session intraputaminal transplantation with of the intended cell dose

    Measured: Baseline to 12 Months Post-Transplant

Secondary outcomes (4)

  1. Efficacy

    Changes in the duration of OFF and ON periods following intracerebral DopaCells transplantation as assessed by the Hauser diary

    Measured: Baseline to 12 Months Post-Transplant

  2. Efficacy

    Changes in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score from baseline following intracerebral DopaCells transplantation during ON and OFF periods ( MDS-UPDRS Part III ranges from 0 to 132, where higher scores indicate worse motor impairment.)

    Measured: Baseline to 12 Months Post-Transplant

  3. Efficacy

    Graft survival following intracerebral DopaCells transplantation based on TRODAT SPECT imaging findings.

    Measured: Baseline to 12 Months Post-Transplant

  4. Continuous Safety

    Continuous Safety: The number and severity of treatment-emergent adverse events

    Measured: Baseline to 60 Months Post-Transplant

Timeline

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

  1. First posted7 May 2026
  2. Study start1 Aug 2025
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Aug 2030 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07572071
Sponsor's protocol ID
402000063
Status last verified
Jun 2026
First submitted
7 Apr 2026
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dopacell, Immunosuppressive Regimen and Customized microinjection device in people with Parkinson Disease (PD), run by Royan Institute at 3 sites in Iran.

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 14 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Iran. 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 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.

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 Sarvenaz Salahi, MD (021-23562000, salahi13639@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: Baseline to 12 Months Post-Transplant). The study lists 3 primary outcomes in all. 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 NCT07572071.

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 18 Jun 2026.

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