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CompletedNCT00641836Updated Mar 24, 2008

Safety and Feasibility of Autologous Endothelial Progenitor Cells Transplantation in Patients With Idiopathic Pulmonary Arterial Hypertension

An interventional study of Transplantation of autologous endothelial progenitor cells in Idiopathic Pulmonary Arterial Hypertension, sponsored by Zhejiang University. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2008-03-24.

Sponsored by Zhejiang University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Recent researches indicate that impairment of vascular and endothelial homeostasis plays a major role in the initiation and development of IPAH.We have recently reported the safety and feasibility data for autologous endothelial progenitor cells (EPCs) injection in patients with IPAH. Yet many questions remain unanswered: what is the ideal quantity of EPCs for therapy, the duration of the therapeutic effect, and moreover, the potential toxicity of such therapy. To help answer these questions, we designed the one year follow-up to investigate the safety and efficacy of autologous EPCs injection in patients with IPAH.

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Conditions studied

  • Idiopathic Pulmonary Arterial Hypertension
03

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 98 is above the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The inclusion criteria included a base-line six minute walking distance between 100 and 450 m
  • A resting mean pulmonary-artery pressure greater than 30 mm Hg
  • A pulmonarycapillary wedge pressure of less than 15 mm Hg
  • Pulmonary vascular resistance greater than 240 dyn•sec•cm-5
  • 18-60 years old

Exclusion criteria

Exclusion Criteria:

  • The exclusion criteria included secondary pulmonary hypertension as a result of heart disease
  • Pulmonary disease
  • Sleep-associated disorders
  • Chronic thromboembolic disease
  • Autoimmune or collagen vascular disease
  • HIV infection
  • Liver disease
  • New York Heart Association functional class IV
  • Major bleeding requiring blood transfusion
  • Diabetes
  • Renal dysfunction
  • Evidence for malignant diseases were excluded
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
98 participants (actual)

Interventions

  • ProcedureTransplantation of autologous endothelial progenitor cells
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Study locations

1 site
  • Department of Cardiology, the First Affiliated Hospital, College of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310003, China
07

References and documents

Publications

  • Wang XX, Zhang FR, Shang YP, Zhu JH, Xie XD, Tao QM, Zhu JH, Chen JZ. Transplantation of autologous endothelial progenitor cells may be beneficial in patients with idiopathic pulmonary arterial hypertension: a pilot randomized controlled trial. J Am Coll Cardiol. 2007 Apr 10;49(14):1566-71. doi: 10.1016/j.jacc.2006.12.037. Epub 2007 Mar 27. PubMed 17418297 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00641836
Lead sponsor
Zhejiang University
First posted
Mar 24, 2008
Start date
Jul 2005
Completion
Dec 2007
Last update
Mar 24, 2008

Study contacts

Junzhu Chen, MD
principal investigator · First Affiliated Hospital of Zhejiang University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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