PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive P… (NCT00683722) | Clinical Trial Compass
CompletedPhase 2
PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
United States62 participantsStarted 2008-03-20
Plain-language summary
The objective of the present study is to establish the safety and efficacy of multiple administrations of Prochymal™(ex-vivo cultured human adult mesenchymal stem cells) in participants with moderate to severe chronic obstructive pulmonary disease (COPD).
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Partici…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.