2025 Stem Cell Research COPD

Stem cell therapy for COPD is very much in its early days. There’s been some research done in Asia and more recently in the US & Australia.

We’ve broken down each study in detail, but we know it’s a lot to digest. 

At the start of the article, we’ve provided an initial summary of what all the research is telling us. 

If you want to look at any study in particular, use the Content Table on the left to go to a particular study.

We hope this is helpful!

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Current Trials looking at Stem Cells treating COPD

REGEND001 Phase I/II Trial: Basal Stem Cells for COPD: China

Who is Running this Trial?

• This clinical trial is being conducted by Ruijin Hospital, Shanghai Jiao Tong University School of Medicine in China. The study is led by Jieming Qu. You can read more about the protocols on their Clinical trials page.

What are They Looking At?

• The main goal of this trial is to evaluate a new stem cell therapy, called REGEND001, for patients with Chronic Obstructive Pulmonary Disease (COPD). Current treatments for COPD focus on managing symptoms, but this study is exploring a new approach that aims to address the actual damage in the lungs.
• The researchers are looking for three main things:
  1. Safety: The most important goal of this early-stage trial is to make sure the therapy is safe and to track any side effects.
  2. Lung Function: They will measure how well a patient’s lungs are working after the treatment. They are specifically looking for improvements in how well gases (like oxygen) are transferred from the lungs into the bloodstream.
  3. Quality of Life: The trial will also use a questionnaire to see if the treatment improves a patient’s daily life, including things like breathlessness, coughing, and chest tightness.
     

Who are the Participants?

• The trial plans to enroll 20 participants.
• To be eligible, they must be between 40 and 80 years old and have a diagnosis of moderate to severe COPD.
• There are also specific health criteria they must meet, such as not having other serious conditions like a history of cancer or certain infections.
  

What Kind of Stem Cells are They Using?

• The therapy uses a specific type of adult stem cell called autologous bronchial basal cells.
  1. Autologous is a very important word here. It means the stem cells are collected directly from the patient’s own body. This completely removes the risk of the body’s immune system rejecting the cells.
  2. Bronchial basal cells are a type of stem cells found in the airways of your lungs. Their job is to replace old or damaged cells in the lung lining.
• The hope is that by collecting, growing and reintroducing these cells, they will help repair the damage caused by COPD.

How Will the Treatment Be Given?

• The process involves a few key steps:
  1. Collection: A small sample of the patient’s lung cells will be collected using a technique called a bronchial brushing. This is done with a thin, flexible tube called a bronchoscope.
  2. Preparation: The collected cells are then sent to a lab where they are grown and multiplied over a period of about 4-8 weeks.
  3. Transplantation: The prepared stem cells are then delivered back to the patient’s lungs, again using a bronchoscope. The patient will stay in the hospital for a day or two for observation.

When Will the Results Be Ready?

• This study has an estimated start date of May 1, 2025. It’s important to remember that this is an estimate and may be subject to change.
• The final follow-up for participants is estimated to be at the end of 2029. This means we will not have the final results for several years.
• Because this is an ongoing trial, there are no results available at this time.

SMS Biotech Phase 1 Trial: SMS Stem Cells for COPD: Australia

You can read more about the study on its ClinicalTrials.gov page.

This is a Phase 1, first-in-human clinical trial being conducted in Australia. The main goal is to test the safety of a new stem cell therapy, called Small Mobile Stem Cells (SMS cells), for people with mild to moderate Chronic Obstructive Pulmonary Disease (COPD). This is an early-stage study, meaning it is the first time this treatment is being tested in humans

Who is Running this Trial?

• This trial is sponsored by SMSbiotech and is being conducted in Australia at Veritas Research in Victoria
  

What are They Looking At?

• The primary goal of this trial is to determine the safety of the SMS cell therapy at different dose levels. As an early-stage study, it will carefully monitor for any side effects.
• The researchers will also measure several secondary outcomes to see if the treatment has any potential benefits, including:
  1. Lung Function: They will use tests like spirometry to measure how well a patient’s lungs are working.
  2. Exercise Tolerance: They will conduct a 6-minute walk test to see how far a patient can walk.
  3. Quality of Life: A questionnaire will be used to measure the patient’s quality of life.

Who are the Participants?

• The trial plans to enroll 18 participants.
• To be eligible, they must be between 39 and 69 years old and have a diagnosis of mild to moderate COPD caused by either cigarette smoking or pollution exposure.
• Participants must have a stable condition and not have had recent flare-ups or hospitalizations related to their disease.
• They must also be non-smokers during the study period.
  

What Kind of Stem Cells are They Using?

• The therapy uses a type of stem cell called Small Mobile Stem Cells (SMS cells).
• The provided information does not specify where these cells come from (e.g., from the patient, a donor, or a specific tissue like bone marrow).
  

How Will the Treatment Be Given?

• The treatment will be delivered directly into the lungs using a medical nebulizer. Participants will inhale a mist containing the SMS cells over a period of 10 to 15 minutes.
• The trial is designed with three different dose groups to test the safety of the treatment at increasing levels. Each group will receive treatments on the 1st, 4th, and 8th days of the study.
• The trial is designed with three different dose groups to test the safety of the treatment at increasing levels. The total volume of the mist for each treatment will be 3 milliliters (less than one teaspoon).
  1. Low Dose: Cohort 1 will receive a concentration of 1.2 billion cells per milliliter, for a total of 3.6 billion cells per treatment.
  2. Medium Dose: Cohort 2 will receive a concentration of 2.4 billion cells per milliliter, for a total of 7.2 billion cells per treatment.
  3. High Dose: Cohort 3 will receive a concentration of 4.8 billion cells per milliliter, for a total of 14.4 billion cells per treatment.
• Each group will receive three treatments on the 1st, 4th, and 8th days of the study.
  

When Will the Results Be Ready?

• This is an active and ongoing trial.
• The estimated start date is June 2025, with an estimated completion date of December 2025.
• Because the study is still recruiting and underway, there are no results available at this time
  

Previous Research looking at Stem cells treating COPD

Umbilical Cord Derived Mesenchymal Stem Cell Clinical Study in Vietnam: 2021

The full study was published in the journal Stem Cell Research & Therapy and you can read the original paper here.

This study tested whether stem cell therapy could reduce symptoms and improve quality of life for people with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).

The main goal was to assess if the treatment was safe and to see if there were any early signs that it was effective.

This was a  pilot clinical study, which is an early-stage trial designed to test a new treatment in a small group of people. It looked at real-world outcomes in patients receiving the therapy.

The research was conducted by scientists and doctors in Vietnam.

Participants:

• 20 patients with moderate-to-severe COPD (classified as Stage C or D) were enrolled in the study.
• To be included, patients had to be between 40-80 years old with a confirmed diagnosis of COPD.
• All 20 patients successfully completed the infusions and the full six-month follow-up period.

Procedure

• Delivery Method: The treatment was given as an intravenous (IV) infusion, meaning the cells were slowly dripped into the patient’s vein over about 45 minutes.
• Cell Type & Source: The study used mesenchymal stem cells derived from umbilical cord tissue.
• Dosage: Each patient received a dose tailored to their body weight: 1.5 million stem cells for every kilogram of their weight.
• Cell Quality: Before use, the cells went through rigorous testing to confirm their identity, purity, and potency (their ability to calm immune cells). They were also screened to ensure they were free of any contamination and would not form tumors.

Key Results

Quality of Life (Primary Efficacy Endpoint):

• Improvements in how patients felt were measured using standard COPD questionnaires.
• The mMRC score, which measures feelings of breathlessness, decreased significantly, indicating patients felt less short of breath in their daily lives.
• The CAT score, a more detailed questionnaire about how COPD affects a person’s life, also showed a significant drop. This demonstrates a notable improvement in overall well-being and a reduction in symptoms.
• The number of COPD exacerbations (severe flare-ups requiring extra medical care) was dramatically reduced in the six months following the treatment
  

Physical Function

• Lung function, measured by the Forced Expiratory Volume (FEV1) test, did not show a statistically significant improvement. This means there was no major change in the amount of air patients could forcefully breathe out.
• The distance patients could walk in a 6-Minute Walk Test (6MWT) also did not significantly increase.

Safety

• The treatment was considered very safe. No patients experienced infusion-related toxicities, deaths, or any serious adverse events that were deemed related to the stem cell administration.

How the Cells Worked

• The researchers believe the stem cells helped primarily through their ability to regulate the immune system and anti-inflammatory properties. They propose:
  1. COPD is a disease of chronic inflammation in the lungs. The umbilical cord stem cells are thought to be particularly effective at calming this inflammation, which in turn reduces symptoms and flare-ups.
     
  2. While MSCs can potentially “home in” on damaged tissue and “differentiate” (turn into new cells), the study suggests the main benefit seen here was from the cells sending out signals that reduced inflammation and helped the body regulate its immune response.

What We Don’t Know (Limitations)

• This was a small pilot study with only 20 participants, so the results need to be confirmed in a larger group of people.
• There was no control or placebo group. This is a significant limitation, as it’s difficult to know for sure if the improvements were a direct result of the stem cells or other factors, since there was no comparison group that did not receive the treatment.
• The follow-up period was only six months, so the long-term effects of the treatment are still unknown.

Conclusion

• This study shows that using stem cells from donated umbilical cords is a promising and safe approach for treating moderate-to-severe COPD.
• While it did not restore lung function, it offered significant improvements in quality of life and reduced the number of dangerous flare ups for patients.
  

2021 Bone Marrow and Adipose Derived Mesenchymal Cells for COPD Phase I Trial: Brazil

The full study, titled “Autologous Infusion of Bone Marrow and Mesenchymal Stromal Cells in Patients with Chronic Obstructive Pulmonary Disease: Phase I Randomized Clinical Trial,” was published in the International Journal of Chronic Obstructive Pulmonary Disease.

This study aimed to test whether infusing different types of stem cells, alone and together, could be a safe and promising new treatment for people with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).

This was a Phase I randomized clinical trial, which is an early-stage study designed to test a new treatment’s safety in a small group of people. It compared patients receiving the therapy to a control group that did not.

The research was conducted by a team of scientists and doctors from several medical and research institutions in Brazil

Participants

• 20 patients with moderate-to-severe COPD were enrolled and randomly divided into four groups of five individuals each.
• Patients had to be between 40 and 70 years old with Grade 3 COPD.
• All 20 patients successfully completed the infusions and the full 12-month follow-up period.

Procedure

• Delivery Method: The treatment was given as an intravenous (IV) infusion, meaning the cells were injected into the patient’s arm vein.
• Cell Type & Source: The study used the patients’ own stem cells from two sources:
  1. Bone Marrow Mononuclear Cells (BMMC): A mix of cells from the bone marrow.
  2. Adipose-Derived Mesenchymal Stromal Cells (ADSC): A specific type of stem cell from fat tissue.
• Dosage: The total dose for each patient who received cells was 100 million cells. The co-infusion group received an equal mix of both cell types:
  50 million BMMC and 50 Million ADSC.
• Cell Quality: Before use, the cells went through extensive testing to confirm their identity and purity and were screened to ensure they were free of any contamination.

Key Results

• Safety (Primary Goal):
  • The treatment was considered safe.
  • No patients experienced complications immediately after the infusions or during the 12-month follow-up period.
  • The most common side effects from the collection procedures were minor, like local pain and bruising.
• Physical Function:
  • The BMMC group showed a notable increase in their lung function, specifically in FEV1 and DLCO, which measure airflow and the lungs’ ability to transfer oxygen.
  • The  Co-infusion group also showed improved gas exchange and a better quality of life. This group also had fewer COPD flare-ups compared to the others.
  • Quality of Life: The Co-infusion group showed the most significant improvement in quality of life, which was measured by a specific questionnaire called the Saint George’s Respiratory Questionnaire (SGRQ).

How the Cells Worked

• The researchers believe the cells helped primarily through a “paracrine effect,” meaning they release signals that help the body heal. The proposed mechanisms are:
  1. Reduced Inflammation: The cells modulate the body’s inflammatory response, which is a major factor in COPD. The co-infusion group showed a decrease in a specific inflammatory marker.
  2. Improved Gas Exchange: The improvements in gas exchange and oxygen consumption in the BMMC group suggest the cells could be helping with the way the lungs transfer gases.
  3. Angiogenesis: The study’s main hypothesis was that combining the two cell types would have an “additive or synergistic effect” that would stimulate the growth of new blood vessels, which could improve lung function.

What We Don’t Know (Limitations)

• Small Sample Size: This was a small study with only 5 patients per group, so the effectiveness results need to be confirmed in a much larger group of people.
• Lack of Placebo Group: While there was a control group receiving standard treatment, there was no placebo group.
• Short Follow-up Period: The follow-up period was 12 months and longer studies are needed to see the long-term effects of the treatment.
• Statistical Concerns: The researchers noted that because the sample size was so small, they did not perform certain statistical tests to avoid misleading the public with potentially false results.

Conclusion

This study reinforced previous findings that stem cell therapy is a safe procedure for COPD. For the first time, it also showed that the combined infusion of BMMC and ADSC is safe. While the small size of the study means that more research is needed to prove its effectiveness, the results are promising and open the door for larger clinical trials in the future.

Lung Institute: Observational Study of Autologous Cell Therapy for COPD and Interstitial Lung Disease: USA: 2020

You can read more about this evidence study here.

This is a real-world observational study that looked at the outcomes of patients with chronic lung disease who received a specific type of cell therapy at a clinic in the United States. 

It was a prospective cohort study, meaning researchers followed the patients over time to observe their results after treatment. Patients paid for their own treatment and the study was designed to explore the safety and effectiveness of the therapy in a real-world setting, rather than a controlled research environment. The study had a large enrollment of 489 participants and took place between 2017 and 2020.

Participants

• The study included 489 adults, aged 16 and older, with either Chronic Obstructive Pulmonary Disease (COPD) or Interstitial Lung Disease (ILD).
• All participants were considered to have a chronic lung condition.
• The majority of patients were over 65 years old (74.4%) and most were male (64.6%).
  

Treatment Procedure

• Each participant received a single-day treatment where their own cells were collected and immediately returned to them.
• The cells were harvested from either their peripheral blood (from a vein) or a combination of their bone marrow and peripheral blood.
• After collection, the cells were processed and then infused back into the patient’s bloodstream. The therapy also included the use of platelet-rich plasma (PRP).
  

Cell Type Used

• The study used the patient’s own cells, specifically those derived from peripheral blood and bone marrow.
• The processed product included Mesenchymal Stem Cells and/or platelet-rich plasma (PRP)
  

Full Results and Success Rates

• Safety: The study found the procedure was safe, with no serious adverse events reported among the 489 participants.
• Quality of Life: Patients reported an improvement in their overall quality of life. The average score on the Clinical COPD Questionnaire (CCQ) improved from 35.35 to 27.96 after three months and 26.87 after six months (a lower score means better quality of life).
• Shortness of Breath (Dyspnea): Patients’ self-reported shortness of breath, as measured by the MMRC scale, showed a change for the better after three months.
• Lung Function: For the 175 COPD patients, the average FEV1% predicted (a measure of lung function) increased slightly from 34.2% at the start to 35.8% after three months

What We Don’t Know

• No Control Group: Because this was an observational study, there was no control or placebo group to compare against. This means researchers cannot definitively say that the improvements were caused by the treatment alone and not other factors, such as the placebo effect.
• Loss to Follow-up: The study had a significant number of participants who did not complete the full follow-up period. Of the 489 participants, 225 were “lost to follow-up” and did not complete the six-month survey. This makes it difficult to draw conclusions about the long-term effects of the treatment for all patients

Reviews looking at Stem Cells Treating COPD

In science, a review isn’t a single experiment,it’s more like a big-picture summary. Instead of testing one small idea, reviews look at lots of different studies on the same topic, gather their results, and explain what the overall evidence shows. 

Think of it as reading dozens of studies then pulling out the key takeaways. What’s promising, what’s unclear and where more research is needed.

2024 Review on Stem Cells for COPD: China

The full review was published in the journal Stem Cell Research & Therapy where you can read it in more detail.

A team of researchers in China from the Second Affiliated Hospital of Fujian Medical University reviewed the available research on using stem cells to treat Chronic Obstructive Pulmonary Disease. Their review focused on Mesenchymal Stem Cells as the most promising option.

What They Looked At

• The researchers conducted a comprehensive review of existing scientific literature and clinical trial data on stem cell therapies for COPD. They examined different types of stem cells, including:
  1. Embryonic Stem Cells (ESCs): Cells with the potential to become any cell type.
  2. Induced Pluripotent Stem Cells (iPSCs): Adult cells that are “reprogrammed” to behave like embryonic stem cells.
  3. Lung Progenitor/Stem Cells: Adult stem cells found directly in the lungs.
  4. Mesenchymal Stem Cells (MSCs): Adult stem cells from sources like bone marrow, fat tissue, and the umbilical cord.
• They also reviewed the results of several clinical trials, including specific trials involving MSCs and lung progenitor cells.
• The review was published in 2024, but the clinical trials they reviewed for MSCs were from the late 2000s and early 2010s

What They Wanted to Find Out

• What is the therapeutic potential of different stem cell types for treating COPD?
• What are the main benefits and drawbacks of each stem cell type?
• What are the mechanisms by which stem cells, especially MSCs, help repair lung damage?
• What are the main challenges and limitations that prevent stem cell therapy from becoming a standard treatment for COPD?

What They Found

1. Effectiveness and Therapeutic Potential
   • MSCs: Preclinical studies (animal models) showed that MSCs could repair lung injury, improve lung function, and decrease inflammation. However, clinical trials in humans have not yet demonstrated the same level of effectiveness. While some trials showed a decrease in inflammation, there was no clear improvement in lung function or quality of life.
   • ESCs and iPSCs: These cells show great potential in lab settings because they can turn into any cell type, but they are not currently a viable treatment for COPD. Their use is limited by a high risk of tumors and immune rejection . iPSCs avoid ethical issues, but still carry the risk of tumor formation from incomplete reprogramming.
   • Lung Progenitor Cells: These cells, which are responsible for lung maintenance and repair, have shown promise in a small clinical study, but they are difficult to get in large quantities.
2. Mechanism of Action
   • The review found that stem cells likely work through two main ways:
     1. Direct Cell Replacement: Stem cells can differentiate (turn into) new, healthy lung cells to replace damaged ones. However, the review suggests this is a minor part of their effect
        
     2. Paracrine Effects: This is believed to be the more important mechanism. Instead of becoming new cells, the stem cells act like a healing signal factory. They release beneficial substances like extracellular vesicles and growth factors that can:
        • Reduce Inflammation: By calming the body’s immune response.
        • Protect Cells: By preventing cell death.
        • Encourage Healing: By stimulating the patient’s own cells to repair the tissue and grow new blood vessels
3.  Safety
   • MSCs: The review highlights that a large number of clinical trials have shown MSCs to be safe. They have a low risk of causing an immune reaction or forming tumors. One trial reported the treatment was safe, and another found no adverse events.
   • ESCs & iPSCs: These cell types have a significant risk of tumor formation (teratomas) and immune rejection after transplantation, which makes them unsuitable for clinical use at this time
     

What They Concluded

• Stem cells, and especially Mesenchymal Stem Cells (MSCs), are a promising future treatment for COPD. However, the research is not yet advanced enough for it to be a standard clinical option.
• To make stem cell therapy a reality for COPD patients, the researchers concluded that we need:
  • More research into the specific mechanisms of action, particularly the “paracrine effects”.
  • More, and better, clinical trials that are designed to be more rigorous (for example, with control groups and larger numbers of patients).
  • A better understanding of the best way to use MSCs, including the best source of cells (from fat, bone marrow, etc.), the right dose and how often to give the treatment.

2023 Review on Stem Cells for COPD: Brazil

The full review was published in the journal European Respiratory Review where you can read it in more detail.

A team of researchers from Brazil reviewed the available research on using stem cells to treat Chronic Obstructive Pulmonary Disease (COPD).

The review focused on cell-based therapies and regenerative medicine in COPD patients, especially those with published clinical trial results.

What They Looked At

• The researchers reviewed existing clinical trials on cell-based therapies for COPD that were registered on the website clinicaltrials.gov and had published results. 
• They primarily focused on trials using Mesenchymal Stromal/Stem Cells from various sources, such as bone marrow and fat tissue, as well as umbilical cords. They also reviewed studies on bone marrow mononuclear cells.

What They Wanted to Find Out

• The main goals of the review were to:
  1. Assess the safety of cell-based therapies for COPD in human patients.
  2. Discuss the questions that remain about the effectiveness, reproducibility and standardization of these treatments.

What They Found

1. Safety: All clinical trials reviewed showed that cell-based therapies were safe, with no serious or major negative side effects reported during the follow-up periods, which ranged from 3 to 30 months. This is a very encouraging and consistent finding across all the protocols.
2. Effectiveness
   • The results regarding effectiveness were mixed and not yet conclusive.
   • Some patients showed a slight, temporary improvement in lung function, but these benefits often disappeared after a month.
   • One trial showed no improvement in lung function or quality of life, but it did find a decrease in a marker of inflammation (C-reactive protein, or CRP), suggesting an anti-inflammatory effect.
   • A different study noted a decrease in shortness of breath and fewer flare-ups of the disease in some patients.
   • One patient in a follow-up study maintained a stable lung function for almost two years, but this was a rare case and not a common result
3. Challenges and Unanswered Questions
   • The review found that many questions need to be answered before this can become a standard treatment.
   • Cell Source and Quality: Researchers don’t yet know if cells from bone marrow, fat tissue, or umbilical cords are better. The effectiveness may also be impacted by the donor’s age or health conditions.
   • Dosage and Timing: There is no agreement on the best number of cells to use or the most effective time to give the treatment (e.g., during the acute or chronic phase of the disease).
   • Delivery Method: It is still debated whether it is better to inject the cells directly into the lungs or through an intravenous (IV) line. The researchers in this review preferred the IV route because it is safer for patients with COPD who may have unstable health conditions.

What They Concluded

• The researchers concluded that while the clinical trials have shown cell-based therapy for COPD to be a safe procedure, there is still not enough evidence to prove it is an effective treatment for the disease.
• They call for more, and larger, international studies to be conducted to find clear answers. The scientific community needs to find a way to “separate the hope from the hype” to manage patient expectations honestly.
  

Conclusion: Research on Stem Cells for COPD

Research is predominantly in Asia, with a couple of research being done in Brazil, the US & 1 current trial in Australia. 

Mesenchymal Stem Cells  are the most frequently studied cell type. The most common sources are bone marrow and  fat tissue, with many studies using autologous cells.

Umbilical cord-derived cells showed positive quality-of-life outcomes in one study, while newer cell types like bronchial basal cells and Small Mobile Stem Cells are the subject of upcoming trials.

The success of the therapy is inconsistent depending on the outcome measured:

• The most common positive results are improvements in patient-reported
  quality of life and a reduction in disease flare-ups (exacerbations).
• Improvements in measured lung function (FEV1) are rare and inconsistent across the trials. One study reported a temporary benefit that disappeared after a month.

How it works:

• The consensus across the studies and reviews is that the cells work primarily through
  paracrine signaling, releasing substances that reduce inflammation.
• The studies suggest the cells do not work by becoming new lung tissue (a process called differentiation).

Safety is a consistent finding across all reviewed trials, with no serious adverse events reported that were attributed to the stem cell infusions.

The reviewed literature shows that the studies used mixed methods (different cell sources, doses, and delivery routes) and produced inconsistent results, particularly for lung function. Common limitations cited were small patient numbers and the lack of proper control or placebo groups.

If you’re thinking about treatment, be aware commercial clinics won’t always follow the same protocols here, whether it’s the way they test cells before the procedure or standards they follow.