Stem Cell Therapy in China: What International Patients Should Check Before Travelling
Evidence last checked: 4 October 2026.
If your current treatment has not brought the improvement you hoped for, it is understandable to look for other options. A report about cell therapy in China may leave you wondering whether travelling could make another approach accessible.
From overseas, even a first enquiry can involve unfamiliar terms, another language and a different healthcare system. Start by finding out what is actually being offered. You do not have to decide on treatment just to ask questions.
Before travelling for stem cell therapy in China, confirm the exact product or procedure, its current authorisation and the evidence for your condition. Then find out whether the team can assess you as an international patient, what the visit would involve and how follow-up would work.
This guide uses lung-cell research as its main example, then walks through the practical questions about records, costs, visits and follow-up before you travel.
Stem cell therapy in China: start with the exact treatment
“Stem cell therapy” can involve cells taken from your own body or a donor, prepared and given in different ways. Evidence for one approach cannot establish the benefit of another simply because both involve cells. [1]
Ask the responsible team to put the treatment's full name in writing, along with the cell source, how the cells are prepared and given, and the condition it is intended to address. You will need those details to check the information you receive.
China has separate routes for medicines and biomedical technologies. Its regulations on biomedical technology research and clinical application took effect on 1 May 2026. For a patient making enquiries from overseas, the practical question is: “What currently authorises this exact project at this institution?” [2] [3]
For an approved medicine, request the product name and authorised indication. Check whether that indication applies to your condition and whether the receiving hospital can provide it.
For an authorised clinical application of a biomedical technology, request the current authorisation and its scope. The procedure and institution being proposed need to fall within it.
For a clinical study, request the study identifier, responsible team, applicable approvals or filings, and participant information. You still need confirmation that recruitment is open, international visitors can participate and you meet the protocol criteria.
Approval is specific. In January 2025, China conditionally approved a human umbilical cord mesenchymal stem-cell medicine for a particular transplant-related complication. Its approval is tied to that indication; it does not establish approval or benefit for a proposed COPD or pulmonary fibrosis treatment. [4]
If a provider refers to an earlier local pilot permission, including in Hainan, ask for the current basis for carrying out the procedure. Official guidance issued after the 2026 regulations requires earlier pilot arrangements to be addressed under the new framework. An older announcement alone leaves that question unresolved. [5]
If the project's identity or current authorisation remains unclear, pause payment and travel plans until the responsible team has clarified it in writing.
Read the studies behind the claim
Match the study to the product, procedure and condition being proposed. Then look at the participant numbers, comparison group and follow-up to understand the strength and limits of the results.
Several lung studies have examined P63+ lung progenitor cells obtained from the patient's airways. This approach differs from an infusion of mesenchymal stromal or stem cells, often abbreviated to MSCs.
Some studies measure DLCO, a test of how well gas passes from the lungs into the blood. A change in that measurement needs to be understood alongside symptoms, daily activity, other treatments and the length of follow-up.
What published P63+ lung-cell studies have reported
Study | Reported findings | Important limits |
COPD: Wang and colleagues, 2024 | The authors reported improvements in gas transfer and walking distance. Of 28 enrolled participants, 20 were evaluable: 17 in the cell group and three controls. 6 | The very small evaluable control group and 24-week observation period limit conclusions about broad or lasting benefit. |
Bronchiectasis: Yan and colleagues, 2024 | A randomised, single-blind study of 37 participants reported early improvement signals compared with airway-clearance treatment alone. 7 | This was a small study. Some authors also disclosed relevant company equity and patent interests. |
Idiopathic pulmonary fibrosis: Zhang and colleagues, 2025 | A 12-person, open-label phase 1 study primarily assessed adverse events and explored possible benefits. 8 | There was no randomised control group. Its safety information should be read with the journal's 2026 correction. 9 |
The cell type matters. A separate, older, placebo-controlled study involving 62 people with COPD examined donor MSCs given intravenously. It found no significant difference between groups in lung function or quality of life. These were different cells and a different procedure from the P63+ studies above. [10]
Then bring the discussion back to your own health:
“Which published results are most relevant to someone with my diagnosis and current health, and what remains uncertain?”
Having the original paper or results record lets you discuss the findings with your treating doctor. A patient testimonial may describe an individual's experience, but it cannot tell you how likely a treatment is to help you. [1]
Can the team assess you before you travel?
An initial enquiry should establish whether the hospital or study team accepts patients with your nationality and residence status, including short-term visitors from overseas.
An English website or a trial listing is only a starting point. The team responsible for the project needs to confirm whether it can consider your case and what language and follow-up arrangements apply.
Ask whether the team can review your records before you travel. If it can, find out what that review can establish and what still needs an examination or testing in China. Some eligibility questions may remain open until you arrive.
Eligibility is specific to the project
For lung-related studies, criteria may include the diagnosis, age, lung-function results, recent infections or admissions, current medicines and other health conditions. A brief recruitment webpage may not contain the full criteria or the same detail as the applicable protocol. [11]
Let the team explain how the current criteria apply to your records. If a medicine appears in an exclusion criterion, discuss it with your clinicians before making any changes.
Recruitment status checked: 4 October 2026. The ClinicalTrials.gov record for the REGEND001 phase 3 COPD study, NCT07828353, stated “Not yet recruiting”. Confirm the current position with the study team before making plans. Registration does not itself establish marketing approval or access for an international visitor. 11 12
Get the records list before paying for translations
You may have years of reports and scans, spread across different clinics. A list from the receiving team gives you somewhere to start.
Get the team's requirements for documents, languages, file formats and any certification before commissioning translations. That helps you avoid paying to translate material it has not requested.
Start with the records you already have
The table below is a starting point for organising existing records. Its categories reflect screening information in the referenced lung studies; the receiving team should specify which records it needs and whether any updated tests are necessary. [11] [13]
Existing material | Details to preserve |
Specialist letters, diagnosis and hospital summaries | Dates, the diagnosis recorded by the clinician and the course of the illness |
Full lung-function reports | FEV1, FVC and DLCO measurements, with units, reference information and any correction details |
Chest CT or HRCT and the radiology report | The written report and, if requested, the original image files in DICOM format |
Recent exacerbations, admissions and breathing-support records | When events occurred and what oxygen or ventilation support was used |
Current medicines and relevant medical history | Generic drug names, doses, frequency, allergies, previous treatment and other conditions |
A translated CT report and the scan itself are separate items. If the team requests original DICOM image files, screenshots or the report alone will not supply that material.
Our guide to preparing medical records for Chinese hospitals can help you bring the requested reports, translations and original scan files together for submission.
Keep the clinical meaning intact
Each translation should stay linked to its original. Dates, medicine names, doses, units and positive or negative findings all need to remain clear. So does uncertainty. A clinician's “possible” diagnosis should still be “possible” in translation.
Flag missing pages or unclear handwriting and seek clarification from the source. A dated file index and a short illness timeline can help organise the submission, with the original reports available for review.
Before sending anything, confirm the team's preferred transfer method and who will receive the documents.
At MedBridgeNZ, our role is to help organise records and clarify the receiving team's document requirements before translation is arranged. We can coordinate questions about missing pages or file formats while keeping originals and translations together.
Understand the procedure before you agree
Ask the clinicians to walk you through what would happen to you, the known risks, what remains uncertain and the alternatives. Have that conversation in a language you understand, with time for your questions before you agree.
Using your own cells does not remove all risk. Collection, preparation and administration each need to be explained in relation to the particular procedure. The ISSCR's patient guidance specifically cautions against treating an autologous—or own-cell—source as a guarantee of safety. [1]
For a lung-cell procedure involving bronchoscopy, ask about the procedure, sedation and risks relevant to your breathing. The published P63+ pulmonary fibrosis study reported events including fever and haemoptysis, or coughing up blood; its 2026 correction updated details of those events. These findings relate to that study and should be discussed in the context of the procedure being offered to you. [8] [9]
If you are considering research participation, establish whether there is random allocation, whether you could enter a control group, how your usual treatment would continue and what happens if you withdraw. Get the arrangements for complications and research-related harm in writing, including who provides care and who pays. [2] [14]
An interpreter can help you communicate with the clinicians. If something is unclear, ask the clinical team to explain it again before you sign.
What would the full trip involve—and cost?
The procedure date may be only one part of the trip. Assessment, cell collection, preparation, administration and follow-up may happen at different times or locations.
For example, REGEND's public patient information describes initial consultation and cell collection at specified centres, with transplantation in Hainan. That is the developer's description of a pathway; the receiving hospital still needs to confirm the locations and arrangements available to an international visitor. [15]
Request a visit plan showing the appointments, locations and any admission or observation. Ask how screening or cell-preparation delays could affect it before choosing flights and accommodation.
What belongs in an itemised quote?
Whether you are joining research or receiving an authorised clinical application affects how charges should be explained. For clinical research conducted under the biomedical technology route, China's regulations prohibit charging participants research-related fees. Authorised clinical applications may charge in accordance with the rules. Drug and medical-device trials follow their respective legal frameworks. [2]
An itemised quote needs to answer four practical questions:
Which costs relate to the study or authorised clinical application, and which are for ordinary medical care?
What will travel, accommodation, interpretation and coordination cost?
Who receives each payment, and does the quote apply to you as an international visitor?
What are the cancellation and refund terms, and what would an extended stay or another visit cost?
If the quote leaves you unsure what you are paying for or what happens if you cannot proceed, get that clarified before paying.
REGEND's study FAQ says the sponsor covers study-related examinations, treatment and follow-up. That statement concerns its research arrangements. Overseas travel and other expenses need separate confirmation. [16]
For people with lung disease, flying needs its own discussion with the treating clinician. That conversation should cover departure and return travel, any oxygen or equipment arrangements, and the timing of travel after a procedure. The British Thoracic Society's air-travel guidance supports assessment according to the person's respiratory condition and travel needs. [17]
For the hospital visit itself, our guide to arranging a specialist visit in China explains how to confirm the appointment, check passport registration requirements and plan language support.
What happens after you return home?
Before leaving for China, ask what follow-up will look like once you are home. Which appointments require another visit? Which tests, if any, can be completed locally? Who will review the results?
A written plan should give you the schedule, accepted report formats, the team's contact details and the circumstances that would require returning to the hospital. If you are joining a study, confirm that any overseas follow-up arrangement meets its protocol; a local test or video call cannot simply be assumed to replace a scheduled visit. [16]
Your treating doctor will need the relevant procedure record, discharge information and follow-up instructions. You also need to know who to contact if a problem develops at home, and how urgent concerns should be handled locally.
Follow-up may be a substantial part of the commitment. Knowing what it requires helps you decide whether the whole pathway fits your health, support and ability to travel.
A few questions before you travel
Does FDA orphan-drug designation mean a lung cell therapy is approved?
No. Orphan-drug designation supports development for rare conditions and is separate from marketing approval. It does not establish that the proposed treatment is authorised in China. [18]
Do all my records need certified Chinese translation?
Confirm the receiving team's requirements before commissioning translations. It should specify which documents need Chinese translation and whether certification or notarisation is necessary. Keep the original records alongside the translated copies.
How long would I need to stay in China?
There is no single timeline. The project and your assessment determine the schedule, including any cell preparation, observation and follow-up. Ask which dates are firm, what could extend your stay and whether another trip would be needed.
What if I am found ineligible after arriving?
Discuss that possibility before booking. Establish what can be checked through records review, what requires assessment in person and how payments or cancellations would be handled if you cannot proceed. A preliminary review may leave some eligibility questions unresolved.
Before you commit to the trip
Take the relevant papers and proposed visit plan to your treating doctor. Discuss what the evidence means for your health, what remains uncertain and whether further enquiries are worthwhile.
You can raise these questions directly with the receiving hospital or study team. For help with records, translation or hospital communication, contact MedBridgeNZ. If you have a project in mind, include its name or website link and a brief outline of the records you already hold. We can help organise the documents and coordinate questions about the receiving team's requirements.
This guide provides general information. MedBridgeNZ is a medical concierge and logistics coordinator; clinical advice and treatment decisions come from your medical team.
Sources
China's Regulations on the Administration of Clinical Research and Clinical Application of New Biomedical Technologies, effective 1 May 2026. Official Chinese text.
National Health Commission: guidance on distinguishing biomedical technologies from medicines and medical devices, April 2026. Official Chinese text.
NMPA conditional approval announcement for 艾米迈托赛注射液, 2 January 2025; reproduced by the Beijing drug regulator. The authorised indication is acute graft-versus-host disease in patients aged 14 and over, with predominantly gastrointestinal involvement after steroid treatment has failed.
Official explanation of the 2026 regulations and earlier pilot arrangements, 8 July 2026; National Health Commission material reproduced by the Shanxi health authority.
Wang et al., P63+ lung progenitor cells in COPD, Science Translational Medicine, 2024. DOI: 10.1126/scitranslmed.adi3360.
Yan et al., P63+ lung progenitor cells in bronchiectasis, Cell Reports Medicine, 2024. DOI: 10.1016/j.xcrm.2024.101819.
Zhang et al., phase 1 P63+ lung progenitor-cell study in idiopathic pulmonary fibrosis, eLife, 2025. DOI: 10.7554/eLife.102451.
Correction to the pulmonary fibrosis study, eLife, 17 April 2026. DOI: 10.7554/eLife.111684.
Weiss et al., placebo-controlled MSC study in COPD, Chest, 2013. DOI: 10.1378/chest.12-2094.
ClinicalTrials.gov: NCT07828353, REGEND001 phase 3 COPD study; registry status checked on 4 October 2026.
ClinicalTrials.gov: registry information and notice concerning listed studies.
ClinicalTrials.gov: NCT05638776, REGEND001 COPD study; existing-record preparation examples also informed by NCT06081621, an IPF study.
ISSCR Guide to Stem Cell Treatments, February 2024.
REGEND: Join Our Therapy. Developer-provided pathway information.
REGEND: Clinical Trials FAQ. Developer-provided study information.
BTS Clinical Statement on air travel for passengers with respiratory disease, Thorax, 2022. DOI: 10.1136/thoraxjnl-2021-218110.
FDA: Designating an Orphan Product—Drugs and Biological Products.
