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

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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
Enrollment 8
Recruitment Details All Participants known to doctors through standard of care appointments in clinic.
Pre-assignment Details All patients meet all inclusion criteria and none of the exclusion criteria.
Arm/Group Title 1*10^6 MSC / kg 2*10^6 MSC / kg
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 4 4
Completed 4 4
Not Completed 0 0
Arm/Group Title 1*10^6 MSC / kg 2*10^6 MSC / kg Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 4 4 8
Hide Baseline Analysis Population Description
All participants meet all inclusion criteria and none of the exclusion criteria
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  50.0%
2
  50.0%
4
  50.0%
>=65 years
2
  50.0%
2
  50.0%
4
  50.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 8 participants
64.1
(62.4 to 66.5)
66.2
(61.1 to 71.5)
64.1
(62.0 to 70.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
Female
1
  25.0%
3
  75.0%
4
  50.0%
Male
3
  75.0%
1
  25.0%
4
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 4 participants 4 participants 8 participants
4 4 8
1.Primary Outcome
Title Number of Participants Who Demonstrated Acute Adverse Events Following Infusion
Hide Description Acute adverse events following infusion was defined as the development of anaphalaxis and/or a 25% increase or decrease from baseline of hemodynamic measurements.
Time Frame 4 hours post-infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data from 8 participants was analyzed. (4 from each group)
Arm/Group Title 1*10^6 MSC / kg 2*10^6 MSC / kg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 4 4
Measure Type: Number
Unit of Measure: participants
0 0
2.Secondary Outcome
Title Percentage Change in Lung Function as Assessed by FVC Compared to Baseline
Hide Description Forced Vital Capacity (FVC) was measured and reported as a percentage of predicted and comapred from 6 months post-infusion to baseline
Time Frame 6 months post MSC infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1*10^6 MSC / kg 2*10^6 MSC / kg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 4 4
Median (Inter-Quartile Range)
Unit of Measure: percentage of baseline
99
(92 to 104)
94
(90 to 97)
3.Secondary Outcome
Title Percentage Change in 6 Minute Walk Distance Compared to Baseline
Hide Description At 6 months 6 Minute Walk Distance was mesured and compared as a percentage to baseline
Time Frame Baseline and 6 months post MSC infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1*10^6 MSC / kg 2*10^6 MSC / kg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 4 4
Median (Inter-Quartile Range)
Unit of Measure: percentage of baseline
104
(103 to 114)
104
(90 to 120)
4.Secondary Outcome
Title Percentage Change in Lung Function as Assessed by DLCO Compared to Baseline
Hide Description DLCO was measured as a percentage of predicted, and the percentage change between 6 months post-infusion and baseline is reported.
Time Frame 6 months post MSC infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1*10^6 MSC / kg 2*10^6 MSC / kg
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 4 4
Median (Inter-Quartile Range)
Unit of Measure: percentage of baseline
117
(96 to 138)
86
(81 to 96)
Time Frame Adverse Events were collected for the duration of the study participation time which was 12 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1*10^6 MSC / kg 2*10^6 MSC / kg
Hide Arm/Group Description

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.

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.

All-Cause Mortality
1*10^6 MSC / kg 2*10^6 MSC / kg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1*10^6 MSC / kg 2*10^6 MSC / kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      0/4 (0.00%)    
Gastrointestinal disorders     
Small Bowel Obstruction * [1]  1/4 (25.00%)  1 0/4 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Patient presented with severe abdominal pain. Analgesia, IV antibiotics and hospital admission. CT Scan confirmed small bowel obstruction. Surgery- Small bowel obstruction secondary to band adhesions. Pt recovered and discharged.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1*10^6 MSC / kg 2*10^6 MSC / kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      4/4 (100.00%)    
Respiratory, thoracic and mediastinal disorders     
Halitosis [1]  4/4 (100.00%)  4 4/4 (100.00%)  4
[1]
All pateints experienced halitosis post infusion
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
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