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

Sponsor
TotipotentSC Scientific Product Pvt. Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01472289
Collaborator
Thermogenesis Corp. (Industry)
17
1
1
28.9
0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the concentrated autologous bone marrow derived stem cells for the treatment of Critical Limb Ischemia patients.

Condition or Disease Intervention/Treatment Phase
  • Other: Autologous Bone Marrow Mononuclear cells (BMMNCs)
Phase 1/Phase 2

Detailed Description

A total of 15 patients suffering from end stage IV and V Rutherford /CLI in whom all previous therapeutic strategies failed (e.g. surgical revascularization) will be selected and undergo local transplantation of autologous BMMNCs. Conventional treatments include angioplasty and /or bypass to remove blood vessel blockage for restoring blood supply, along with prescribed medicines that aid in ulcer recovery and wound healing and debridement of damaged/infected tissue. Amputation is inevitable in many cases because some blood capillaries cannot be corrected and restenosis of vessels is very common. Cell therapies with mononuclear cells from patients own bone marrow is promising because these stem cells are capable of stimulating and regenerating capillaries and blood vessels (neovascularization).

This is a Phase Ib (feasibility study), prospective, non randomized and open labeled study aimed to find out the safety and efficacy of intramuscular autologous bone marrow mononuclear cells implantation in patients with chronic critical limb ischemia.

The efficacy/safety of this therapy will be assessed by using several endpoints such as (a) prevention of amputation, (b) wound healing and (c) degree of angiogenesis. In order to assess the limb ischemia, the measurements will be performed at pre- and post transplantation at a variety of time intervals. The measurements include: ABI-ankle brachial index, Transcutaneous partial pressure of Oxygen (TcPO2), 6 min walk test, Rest pain and intermittent Claudication assessment, Healing of ulcers/ wounds and angiography of the affected limb.

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
To Study and Demonstrate the Safety and Efficacy of RES-Q Prepared Bone Marrow Mononuclear Cells Injected Into Ischemic Tissue of Patients With Non-Reconstructable Critical Limb Ischemia (CLI).
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMMNC treated group

Autologous bone marrow mononuclear cell concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) to be injected intramuscularly into multiple sites in the ischemic muscle tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.

Other: Autologous Bone Marrow Mononuclear cells (BMMNCs)
Multiple intramuscular injections of concentrated bone marrow derived mononuclear cells (0.5 cc/injection) into the ischemic muscle of the affected limb.
Other Names:
  • Autologous bone marrow mononuclear cell concentrate
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Adverse Events as a Measure of Safety and Major Limb Amputation Free Survival Post BMMNC Administration [1, 3, 6 and 12 Months]

      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.

    Secondary Outcome Measures

    1. Degree of Angiogenesis Measured by the Number of Collateral Blood Vessels Formed at 12 Months [Baseline and 12 month]

      Measurement of blood supply facilitated by the formation of collateral blood vessels assessed by CT angiography after the procedure.

    2. Measurement of Mean Change in Ankle Brachial Index From Baseline to 12 Months [Baseline, 1, 3, 6 and 12 months]

      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.

    3. Measurement of Change in Transcutaneous Oxygen Pressure (TcPO2) From Baseline to 12 Months [Baseline, 1, 3, 6 and 12 months]

      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.

    4. Change in Rest Pain and Intermittent Claudication Assessment From Baseline to 12 Months [Baseline, 1, 3, 6 and 12 months]

      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.

    5. Clinical Evaluation for the Presence of Ulcer and/or Gangrene in the Affected Limb From Baseline to 12 Months [Baseline, 1, 3, 6 and 12 months]

      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.

    6. Number of Participants Able to Walk From Baseline to 12 Months as Measured by 6-Minute Walk Test [Baseline, 1, 3, 6 and 12 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Atherosclerotic ischemic peripheral vascular disease (PVD) or Thromboangiitis Obliterans with severe Critical Limb Ischemia (Rutherford Category 4 and 5: ischemic pain at rest and minor tissue loss and Fontaine Class 4: Ischemic ulcers or gangrene, whivh may be dry or humid).

    • A non-surgical candidate for revascularization e.g. prior vascular reconstruction, inability to locate a suitable vein for grafting, diffuse multi- segment disease, or extensive infra-popliteal disease not amenable to a vascular graft.

    • Major amputation recommended patients due to severe life threatening PAD.

    • Subjects must be on maximal tolerated medical therapy for peripheral vascular disease including A) Cessation of smoking B) Referral to endocrinologist for control of HgA1c to < 8% mg/dl, C) control of hyperlipidemia with statins or other anti-hyperlipidemic drugs as indicated, D) control of hypertension as indicated E) Antiplatelet therapy with aspirin and / or cilostazol (unless medically contraindicated, e.g. bleeding or allergy).

    • Ankle Brachial Pressure Index (ABI) ≤ 0.6 or ankle systolic pressure ≤ 60 mm Hg or TcPO2 ≤ 35 mmHg in the foot.

    • Subjects who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, which abide by the study requirements, and agree to return for required follow-up visits.

    Exclusion Criteria:
    • Subjects with CLI suitable for surgical or percutaneous revascularization and Subjects with acute and chronic inflammatory condition.

    • CLI patient requiring amputation proximal to trans-metatarsal level

    • Subjects with spreading (wet) gangrene

    • Subjects with gait disturbance for reasons other than CLI.

    • Subjects with poorly controlled diabetes mellitus.

    • Subjects diagnosed with Thromboangiitis Obliterans (Buerger's Disease) who are smokers and are unwilling or unable to quit smoking or the physician feels the smoking cessation is doubtful.

    • Subjects having moderate to severe COPD with GOLD Classification IIb or III.

    • Uncontrolled congestive heart failure or Subjects with left ventricular ejection fraction < 25% or AHA Stage C or D heart failure or NYHA Class IV CHF

    • Stroke or myocardial infarction within last 3 months.

    • Subjects who are contraindicated for CT Angiogram.

    • Illnesses or conditions that are uncontrolled or whose control, in the opinion of the Principal Investigator, may be jeopardized by participation in this study or by the complications of this therapy.

    • Documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 1 year.

    • Subjects already enrolled in another investigational drug trial or completed within 3 months.

    • History of severe alcohol or drug abuse within 3 months of screening.

    • Hb% < 10 gm%; Serum creatinine ≥ 2.0mg%; Serum total bilirubin ≥2.0mg%; HbA1c > 8.0%.

    • Women of child bearing potential; pregnant and lactating women.

    • Subjects with a) myocardial infarction within the last 30 days or left ventricular ejection fraction < 35%, B) Subjects with a cerebrovascular accident within the last 6 months.

    • INR > 1.5 at the time of Bone Marrow harvest.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fortis Escorts Heart Institute & Research Centre New Delhi India

    Sponsors and Collaborators

    • TotipotentSC Scientific Product Pvt. Ltd.
    • Thermogenesis Corp.

    Investigators

    • Study Director: Venkatesh Ponemone, PhD, TotipotentRX, Center for Cellular Medicine
    • Study Chair: Kenneth Harris, MS, TotipotentRX, Centre for Cellular Medicine
    • Principal Investigator: Suhail Bukhari, MBBS, FNBE, Fortis Escorts Heart Institute and Research Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TotipotentSC Scientific Product Pvt. Ltd.
    ClinicalTrials.gov Identifier:
    NCT01472289
    Other Study ID Numbers:
    • TPSC/POC/BMSC/CLI/2010/1b
    • 050343290-0702201132855389
    First Posted:
    Nov 16, 2011
    Last Update Posted:
    Nov 18, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by TotipotentSC Scientific Product Pvt. Ltd.
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title BMMNC Treated Group
    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

    Baseline Characteristics

    Arm/Group Title BMMNC Treated Group
    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 Participants 17
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    48.8
    (13.07)
    Sex: Female, Male (Count of Participants)
    Female
    2
    11.8%
    Male
    15
    88.2%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    17
    100%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    0
    0%
    White
    0
    0%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (participants) [Number]
    India
    17
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Adverse Events as a Measure of Safety and Major Limb Amputation Free Survival Post BMMNC Administration
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 17
    Major Limb Amputation Free Survival Rate
    14
    82.4%
    Major Amputation
    3
    17.6%
    Minor Amputation
    2
    11.8%
    Unrelated Death
    2
    11.8%
    Total Adverse Events
    7
    41.2%
    2. Secondary Outcome
    Title Degree of Angiogenesis Measured by the Number of Collateral Blood Vessels Formed at 12 Months
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 14
    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
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 14
    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
    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

    Outcome Measure Data

    Analysis Population Description
    The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).
    Arm/Group Title BMMNC Treated Group
    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.
    Measure Participants 14
    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
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 14
    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
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 14
    Ulcer and/ or Gangrene present at Baseline
    11
    64.7%
    Ulcer and/or Gangrene present at 1 Month
    10
    58.8%
    Ulcer and/or Gangrene present at 3 Months
    6
    35.3%
    Ulcer and/or Gangrene present at 6 Months
    2
    11.8%
    Ulcer and/ or Gangrene present at 12 Months
    0
    0%
    7. Secondary Outcome
    Title Number of Participants Able to Walk From Baseline to 12 Months as Measured by 6-Minute Walk Test
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 14
    Subjects able to walk at baseline
    2
    11.8%
    Subjects able to walk at 1 Month
    8
    47.1%
    Subjects able to walk at 3 Months
    9
    52.9%
    Subjects able to walk at 6 Months
    9
    52.9%
    Subjects able to walk at 12 Months
    9
    52.9%

    Adverse Events

    Time Frame Adverse events were reported for the duration of the study, that is, from baseline to 12 Months
    Adverse Event Reporting Description
    Arm/Group Title BMMNC Treated Group
    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 (%) # Events
    Total / (NaN)
    Serious Adverse Events
    BMMNC Treated Group
    Affected / at Risk (%) # Events
    Total 7/17 (41.2%)
    Cardiac disorders
    Death 2/17 (11.8%) 2
    Vascular disorders
    Major Limb Amputation 3/17 (17.6%) 3
    Minor Limb Amputation 2/17 (11.8%) 2
    Other (Not Including Serious) Adverse Events
    BMMNC Treated Group
    Affected / at Risk (%) # Events
    Total 0/17 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Dr. Venkatesh Ponemone
    Organization TotipotentSC
    Phone +91-124-4976860
    Email venkatesh.ponemone@totipotentsc.com
    Responsible Party:
    TotipotentSC Scientific Product Pvt. Ltd.
    ClinicalTrials.gov Identifier:
    NCT01472289
    Other Study ID Numbers:
    • TPSC/POC/BMSC/CLI/2010/1b
    • 050343290-0702201132855389
    First Posted:
    Nov 16, 2011
    Last Update Posted:
    Nov 18, 2015
    Last Verified:
    Oct 1, 2015