Could stem cells help breathe easier? new trial tests PROCHYMAL for COPD
NCT ID NCT00683722
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tested whether infusions of PROCHYMAL, a stem cell product, are safe and can help people with moderate to severe COPD. 62 participants received either stem cells or a placebo. The main goal was to check for side effects, and researchers also looked at changes in lung function over two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PROCHYMAL (adult stem cells from bone marrow)
- What this could lead to
- If it works, this could point toward a new way to treat COPD by reducing inflammation and possibly improving lung function.
- What could go wrong
- This is an early phase 2 trial with only 62 people, so results may not apply to everyone. Stem cell treatments can have unknown long-term risks, and the placebo group may show similar benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
62 people
The number who actually took part.
- Started
-
Mar 2008
- Finished
-
Aug 2010
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participant must have a diagnosis of moderate or severe COPD. * Participant must have a post-bronchodilator FEV1/forced vital capacity (FVC) ratio \< 0.7. * Participant must have a post-bronchodilator FEV1 % predicted value ≥ 30% and \< 70%. * Participant must be between 40 and 80 years of age, of either sex, and of any race. * Participant must be a current or ex-smoker, with a cigarette smoking history of ≥ 10 years or \> 10 pack-years. Exclusion Criteria: * Participant has been diagnosed with asthma or other clinically relevant lung disease other than COPD (e.g. restrictive lung diseases, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, bronchiectasis, or lung cancer). * Participant has been diagnosed with α1-antitrypsin deficiency. * Participant has a body mass greater than 150 kg (330 lb) or less than 40 kg (88 lb). * Participant has active infection. * Participant has had a significant exacerbation of COPD or has required mechanical ventilation within 4 weeks of screening. * The participant with clinically relevant uncontrolled medical condition not associated with COPD. * Participant has documented history of uncontrolled heart failure. * Participant has pulmonary hypertension due to left heart condition. * Participant has atrial fibrillation or significant congenital heart defect/disease. * Participant has initiated pulmonary rehabilitation within 3 months of screening. * Participant is allergic to bovine or porcine products. * Participant has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years. * Participant has a life expectancy of \< 6 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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American Health Research
Charlotte, North Carolina, 28207, United States
-
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095, United States
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Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
Torrance, California, 90502, United States
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Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
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Upstate Pharmaceutical Research
Greenville, South Carolina, 29615, United States
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Vermont Lung Center, University of Vermont
Burlington, Vermont, 05446, United States
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