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Trial record 57 of 70 for:    stem cell peripheral arterial disease AND cell therapy

Safety and Efficacy of Autologous Bone Marrow Mononuclear Cells in Patients With Severe Critical Limb Ischemia

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ClinicalTrials.gov Identifier: NCT01472289
Recruitment Status : Completed
First Posted : November 16, 2011
Results First Posted : November 18, 2015
Last Update Posted : November 18, 2015
Sponsor:
Collaborator:
Thermogenesis Corp.
Information provided by (Responsible Party):
TotipotentSC Scientific Product Pvt. Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Critical Limb Ischemia
Intervention Other: Autologous Bone Marrow Mononuclear cells (BMMNCs)
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BMMNC Treated Group
Hide Arm/Group Description All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells (BMMNCs) concentrate prepared using the Res-Q 60 technology (a point of care system) and injected the concentrate intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
Period Title: Overall Study
Started 17
Completed 15
Not Completed 2
Reason Not Completed
Death             2
Arm/Group Title BMMNC Treated Group
Hide Arm/Group Description All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic muscle of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
A total of 17 subjects who met the eligibility criteria were enrolled in this study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
48.8  (13.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
2
  11.8%
Male
15
  88.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
American Indian or Alaska Native
0
   0.0%
Asian
17
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 17 participants
17
1.Primary Outcome
Title Number of Participants With Adverse Events as a Measure of Safety and Major Limb Amputation Free Survival Post BMMNC Administration
Hide Description The Primary objective of this study was to determine the safety of intramuscular administration of concentrated autologous BMMNCs harvested, and processed using the Res-Q 60 technology (a point-of-care system). Safety measurements included close vigilance for major limb amputation free survival at 1, 3, 6 and 12 months post BMMNCs administration and stringent reporting of AEs and SAEs.
Time Frame 1, 3, 6 and 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All the safety end points in the study were analyzed on the ITT population. Out of 17 subjects, adverse events were reported for seven subjects. Of the seven subjects, three underwent major amputation, two reported minor amputation, and two died due to cardiac arrest (unrelated death). Furthermore, major limb amputation free survival rate was 14.
Arm/Group Title BMMNC Treated Group
Hide Arm/Group Description:
All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
Major Limb Amputation Free Survival Rate 14
Major Amputation 3
Minor Amputation 2
Unrelated Death 2
Total Adverse Events 7
2.Secondary Outcome
Title Degree of Angiogenesis Measured by the Number of Collateral Blood Vessels Formed at 12 Months
Hide Description Measurement of blood supply facilitated by the formation of collateral blood vessels assessed by CT angiography after the procedure.
Time Frame Baseline and 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).
Arm/Group Title BMMNC Treated Group
Hide Arm/Group Description:
All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: Number of Vessels
Number of Collateral vessels at Baseline 2.42  (0.775)
Number of Collateral vessels at 12 months 5.59  (1.146)
3.Secondary Outcome
Title Measurement of Mean Change in Ankle Brachial Index From Baseline to 12 Months
Hide Description ABI was used to provide a measure of blood flow in the lower limbs. It is the ratio of the blood pressure in the lower limbs to the blood pressure in the upper limbs. Compared to the upper limb, lower blood pressure in the lower limb is an indication of blocked arteries (peripheral vascular disease). The ABI was calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. ABI test was performed at baseline, 1 month, 3 months, 6 months, and 12 months.
Time Frame Baseline, 1, 3, 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).
Arm/Group Title BMMNC Treated Group
Hide Arm/Group Description:
All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: Ratio
ABI at Baseline 0.507  (0.0971)
ABI at 1 Month 0.612  (0.1653)
ABI at 3 Months 0.819  (0.2829)
ABI at 6 Months 0.879  (0.2467)
ABI at 12 Months 0.696  (0.2650)
4.Secondary Outcome
Title Measurement of Change in Transcutaneous Oxygen Pressure (TcPO2) From Baseline to 12 Months
Hide Description TcPO2 was used to assess the partial pressure (tension) of oxygen in the capillaries of tissues of lower limbs. It was measured by applying a special set of electrodes to the skin. These electrodes contain photoelectric sensors capable of detecting the specific wavelengths of radiation emitted by oxygenated versus reduced hemoglobin.
Time Frame Baseline, 1, 3, 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).
Arm/Group Title BMMNC Treated Group
Hide Arm/Group Description:
All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mmHg
TcPO2 at Baseline 14.66  (6.925)
TcPO2 at 1 Month 25.10  (11.906)
TcPO2 at 3 Months 36.85  (17.892)
TcPO2 at 6 Months 34.58  (15.500)
TcPO2 at 12 Months 35.75  (17.035)
5.Secondary Outcome
Title Change in Rest Pain and Intermittent Claudication Assessment From Baseline to 12 Months
Hide Description

Rest pain is a burning sensation felt at rest, usually in the skin of the foot. It is a symptom of critical ischemia due to severe, chronic, and occlusive peripheral arterial disease (PAD). While, Intermittent Claudication is a crampy leg pain that occurs during exercise, especially walking. The pain is due to the insufficient blood flow in the legs (caused by blocked arteries). Intermittent claudication is the most prominent symptom of PAD.

Both Rest Pain assessment and Intermittent Claudication assessment was performed through Visual Analog Scale or Visual Analogue Scale (VAS). VAS is a psychometric (self-report) response scale that ranges from 0 to 10, where a mark of zero indicates no pain and a mark of 10 indicates worst possible pain.

Time Frame Baseline, 1, 3, 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).
Arm/Group Title BMMNC Treated Group
Hide Arm/Group Description:
All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Rest Pain Score at Baseline 2.80  (0.80)
Rest Pain Score at 1 Month 1.2  (1.17)
Rest Pain Score at 3 Months 0.6  (0.87)
Rest Pain Score at 6 Months 0.4  (0.90)
Rest Pain Score at 12 Months 0.0  (0.00)
Intermittent Claudication Pain Score at Baseline 7.80  (0.97)
Intermittent Claudication Pain Score at 1 Month 4.9  (2.22)
Intermittent Claudication Pain Score at 3 Months 2.8  (2.61)
Intermittent Claudication Pain Score at 6 Months 1.1  (1.44)
Intermittent Claudication Pain Score at 12 Months 0.2  (0.58)
6.Secondary Outcome
Title Clinical Evaluation for the Presence of Ulcer and/or Gangrene in the Affected Limb From Baseline to 12 Months
Hide Description Evaluation of the integument for ulceration, gangrene and other skin changes in the affected limb was performed at baseline and follow-up visits at 1 month, 3 months, 6 months, and 12 months.The ulceration and gangrene in the affected limb of the subjects was evaluated by visual clinical inspection.
Time Frame Baseline, 1, 3, 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).
Arm/Group Title BMMNC Treated Group
Hide Arm/Group Description:
All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
Ulcer and/ or Gangrene present at Baseline 11
Ulcer and/or Gangrene present at 1 Month 10
Ulcer and/or Gangrene present at 3 Months 6
Ulcer and/or Gangrene present at 6 Months 2
Ulcer and/ or Gangrene present at 12 Months 0
7.Secondary Outcome
Title Number of Participants Able to Walk From Baseline to 12 Months as Measured by 6-Minute Walk Test
Hide Description Subjects were analyzed to see if they were able to walk any distance and the distance covered by patients in 6 minutes was measured to assess the functional changes from baseline. The American Thoracic Society has issued guidelines for the 6-minute walk test (6 MWT). The 6 MWT is safe, easy to administer, well tolerated, and reflects activities of daily living.
Time Frame Baseline, 1, 3, 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).
Arm/Group Title BMMNC Treated Group
Hide Arm/Group Description:
All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
Subjects able to walk at baseline 2
Subjects able to walk at 1 Month 8
Subjects able to walk at 3 Months 9
Subjects able to walk at 6 Months 9
Subjects able to walk at 12 Months 9
Time Frame Adverse events were reported for the duration of the study, that is, from baseline to 12 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BMMNC Treated Group
Hide Arm/Group Description All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic muscle of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
All-Cause Mortality
BMMNC Treated Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
BMMNC Treated Group
Affected / at Risk (%) # Events
Total   7/17 (41.18%)    
Cardiac disorders   
Death   2/17 (11.76%)  2
Vascular disorders   
Major Limb Amputation   3/17 (17.65%)  3
Minor Limb Amputation   2/17 (11.76%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BMMNC Treated Group
Affected / at Risk (%) # Events
Total   0/17 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Venkatesh Ponemone
Organization: TotipotentSC
Phone: +91-124-4976860
EMail: venkatesh.ponemone@totipotentsc.com
Layout table for additonal information
Responsible Party: TotipotentSC Scientific Product Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01472289     History of Changes
Other Study ID Numbers: TPSC/POC/BMSC/CLI/2010/1b
050343290-0702201132855389 ( Registry Identifier: Clinical Trials Registry - India (CTRI) )
First Submitted: July 18, 2011
First Posted: November 16, 2011
Results First Submitted: July 17, 2015
Results First Posted: November 18, 2015
Last Update Posted: November 18, 2015