ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 94 of 799 for:    Interventional Studies | mesenchymal

A Study to Evaluate the Potential Role of Mesenchymal Stem Cells in the Treatment of Idiopathic Pulmonary Fibrosis (MSC in IPF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01385644
Recruitment Status : Completed
First Posted : June 30, 2011
Results First Posted : December 29, 2015
Last Update Posted : December 29, 2015
Sponsor:
Collaborator:
Mater Medical Research Institute
Information provided by (Responsible Party):
Daniel Chambers, The Prince Charles Hospital

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Idiopathic Pulmonary Fibrosis
Intervention: Other: Placental MSC

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All Participants known to doctors through standard of care appointments in clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients meet all inclusion criteria and none of the exclusion criteria.

Reporting Groups
  Description
1*10^6 MSC / kg

Placental MSC

Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients.

2*10^6 MSC / kg

Placental MSC

Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients.


Participant Flow:   Overall Study
    1*10^6 MSC / kg   2*10^6 MSC / kg
STARTED   4   4 
COMPLETED   4   4 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants meet all inclusion criteria and none of the exclusion criteria

Reporting Groups
  Description
1*10^6 MSC / kg

Placental MSC

Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients.

2*10^6 MSC / kg

Placental MSC

Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients.

Total Total of all reporting groups

Baseline Measures
   1*10^6 MSC / kg   2*10^6 MSC / kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   4   8 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   2   2   4 
>=65 years   2   2   4 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 64.1 
 (62.4 to 66.5) 
 66.2 
 (61.1 to 71.5) 
 64.1 
 (62.0 to 70.0) 
Gender 
[Units: Participants]
     
Female   1   3   4 
Male   3   1   4 
Region of Enrollment 
[Units: Participants]
     
Australia   4   4   8 


  Outcome Measures

1.  Primary:   Number of Participants Who Demonstrated Acute Adverse Events Following Infusion   [ Time Frame: 4 hours post-infusion ]

2.  Secondary:   Percentage Change in Lung Function as Assessed by FVC Compared to Baseline   [ Time Frame: 6 months post MSC infusion ]

3.  Secondary:   Percentage Change in 6 Minute Walk Distance Compared to Baseline   [ Time Frame: Baseline and 6 months post MSC infusion ]

4.  Secondary:   Percentage Change in Lung Function as Assessed by DLCO Compared to Baseline   [ Time Frame: 6 months post MSC infusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Assoc Professor Daniel Chambers
Organization: The Prince Chalres Hospital
phone: +61 7 3139 4000
e-mail: daniel.chambers@health.qld.gov.au



Responsible Party: Daniel Chambers, The Prince Charles Hospital
ClinicalTrials.gov Identifier: NCT01385644     History of Changes
Other Study ID Numbers: HREC/09/QPCH/105
First Submitted: May 4, 2011
First Posted: June 30, 2011
Results First Submitted: October 20, 2015
Results First Posted: December 29, 2015
Last Update Posted: December 29, 2015