NCT00641836

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
Last Updated

March 24, 2008

Status Verified

March 1, 2008

First QC Date

March 18, 2008

Last Update Submit

March 18, 2008

Conditions

Idiopathic Pulmonary Arterial Hypertension

Interventions

Transplantation of autologous endothelial progenitor cellsPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, the First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

  • 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.

    PMID: 17418297RESULT

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Junzhu Chen, MD

    First Affiliated Hospital of Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 24, 2008

Study Start

July 1, 2005

Study Completion

December 1, 2007

Last Updated

March 24, 2008

Record last verified: 2008-03

Locations

CN(1)