To Evaluate the Safety and Efficacy of IM and IV Administration of Autologous ADMSCs for Treatment of CLI
A Prospective, Multicentric, Phase I/II, Open Label, Randomized, Interventional Study to Evaluate the Safety and Efficacy of Intramuscular and Intravenous Administration of Autologous ADMSCS for Treatment of Critical Limb Ischemia (CLI).
1 other identifier
interventional
60
1 country
1
Brief Summary
Various preclinical animal studies have shown the potential of stem cells in re-vascularising ischemic limbs and promoting collateral vessel formation. SVF have the potential to facilitate the formation of new blood vessels and skeletal muscle. Early pilot clinical studies indicate that stem-cell transplantation is feasible and may have beneficial effects in CLI. Injury or inflammation is a prerequisite for the participation of circulating stem cells to home and differentiate on to this microenvironment. The increased vascular permeability and expression of adhesion proteins like integrin assist in stem cell homing. The migratory capacity of stem cells is dependent on natural growth factors such as vascular endothelial growth factor (VEGF), Stromal cell derived factor (SDFI) and stem cell factor (SCF). The expression of VEGF, SDFI and SCF is highly unregulated in the hypoxic muscular tissue and is responsible for the recruitment of the stem cells to assist in the repair mechanism and consequent improvement in limb function. In addition to the above regenerating potential of SVF, they have several advantages; they can be easily isolated without further culturing it. Most importantly SVF have shown to have significantly highest expression of pluripotent markers similar to that of human embryonic stem cells and yet they are non-tumorogenic and safe. MSCs are having angiogenic activity and hence may be excellent source to develop neo-vasculature and hence could be explored for their therapeutic potential for treating Critical Limb Ischemia. MSC's also display membrane-bound and insoluble secreted molecules involved with cell attachment to neighbouring cells and to the extra cellular matrix19 Adipose derived Stromal vascular fraction and Mesenchymal Stem Cells has been found in preclinical studies to be safe and effective. The current Phase I/II study of adipose derived stromal vascular fraction and Mesenchymal stem cells is conducted with the broad objective of establishing safety and efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2014
CompletedFirst Posted
Study publicly available on registry
May 23, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedMay 23, 2014
May 1, 2014
1 year
May 8, 2014
May 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety
The Incidence of treatment emergent Adverse Event (AE) in the study.
9 months
Secondary Outcomes (1)
To assess the efficacy
9 months
Other Outcomes (2)
Safety
9 months
Efficacy
9 months
Study Arms (3)
Autologous Stromal Vascular Fraction
EXPERIMENTALsingle dose of autologous adipose derived Stromal Vascular Fraction (SVF) SVF divided in two fraction and infused intravenously and intramuscularly
Autologous Adipose Derived MSCs
EXPERIMENTALOne dose of 1 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intravenously and one dose of 1 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intramuscularly
Control
ACTIVE COMPARATORInterventions
Study arm A subjects will receive single dose of autologous adipose derived Stromal Vascular Fraction (SVF) SVF divided in two fraction and infused intravenously and intramuscularly
Study arm B subjects will receive one dose of 1 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intravenously and one dose of 1 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intramuscularly
Eligibility Criteria
You may qualify if:
- \. Critical limb ischemia (rest pain, un-healing wound/ulcer lasting more than 4 weeks)
- \. Category 4 \& 5 Rutherford-Becker peripheral vascular disease affecting at least one limb with or without un-healing ulcer/wound of grade I or II on the Wagner scale
- \. Ankle -brachial index \<0.6
- \. TcpO2 \< 45 mm Hg measured at toe
- \. Life expectancy more than 2 years
- \. Subjects (male and female), aged 18 to 65 years (both inclusive)
- \. Glycosylated hemoglobin (HbA1C) ≤7 %
- \. INR value of below 2 before liposuction procedure
- \. Subject should be compliant to the treatment regimen follow like insulin, anti-diabetic drugs for the entire duration of the clinical study
- \. Subject who are not currently on or have discontinued treatment with immune-suppressants and/or corticosteroids within at least 20 days prior to screening
- \. Subject willing to give Informed Consent
You may not qualify if:
- Uncontrolled high blood pressure
- Uncontrolled diabetes with Glycosylated hemoglobin (HbA1C) \> 7%
- Severe cardiac insufficiency (Ejection fraction \< 35%)
- Frank infected ulcers with purulent discharge resulting in excessive infections, ulcers with exposed bone, fascia, joints, ligaments or tendons (Category 6 Rutherford-Becker peripheral vascular disease)
- Subject diagnosed with cancer undergoing chemotherapy.
- Poor nutritional status as measured by serum albumin \<3.0 g/dL.
- Severe anemia Hb \< 7g/dl.
- Subject had a leg revascularization surgery or history of amputation within the last 6 months or be a candidate for revascularization surgery during the course of the study.
- Other unusual or rare forms of diabetes mellitus, or history of diabetic ketoacidosis or osteomyletis.
- Subject unfit to undergo lipoaspiration as determined by the surgeon.
- Subject has a history of bleeding disorder or clotting disorder
- Have any condition, disease, disorder, or clinically significant laboratory abnormality that, in the opinion of the Investigator, would jeopardize the subjects' appropriate participation in this study or obscure the effects of treatment.
- Pregnant or lactating women or women of child-bearing potential not using medically acceptable methods of contraception or women with positive urine pregnancy test (UPT) at screening
- Subjects unwilling or unable to comply with the study procedures
- Have received treatment with any investigational product (IP) or participated in any investigational study within 30 days or 5 half-lives of the IP, whichever is longer, before the Screening Visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kasiak Research Pvt Ltd
Thane, Maharashtra, 400 610, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Arun B Bal, M.B.B.S.M.S.
SL Raheja Hospital
- PRINCIPAL INVESTIGATOR
Dr. Ashish S Johari, M.B.B.S.M.S.
Jaslok Hospital and Research Centre
- PRINCIPAL INVESTIGATOR
Dr. Meena Kumar, M.B.B.S.M.S.
L T M C and L T M M General Hospital ,Sion
- PRINCIPAL INVESTIGATOR
R Shekhar, M.B.B.S.M.S.
Kokilaben Dhirubai Ambani Hospital and Medical Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2014
First Posted
May 23, 2014
Study Start
August 1, 2014
Primary Completion
August 1, 2015
Last Updated
May 23, 2014
Record last verified: 2014-05