CTRI/2023/05/052776尚未招募2 期
A Multi-Centre, Randomized, Open label, Parallel group, Active control Phase II study to evaluate the efficacy and safety of Fetal Progenitor Cells v/s Bone Marrow Autologous Mononuclear Cells v/s Standard of Care in Chronic Lower Limb Ischemia and treatment of CLI long-term Non- Healing Ischemic Wounds and Ulcers
Relabs Private Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Key Inclusion Criteria (CLI without wounds and ulcers):
- •Patients must meet the following inclusion criteria to be
- •included in the study:
- •1. M/F age group of 18-65 years of Indian origin.
- •2. Rutherford II-4 clinically and hemodynamically
- •established Chronic Lower Limb Ischemia
- •3. Patients having Infra-inguinal arterial occlusive disease with rest pain or ischemic ulcer/ necrosis, who are not eligible for or have failed traditional revascularization treatment.
- •4. Patients failed basic conservative and standard
- •revascularization treatment (Surgical/Endovascular)
- •5. Ankle Brachial Pressure Index (ABPI) <= 0.6 or ankle pressure <=70 mm Hg or TcPO2 <= 60 mm Hg in the foot of the study limb.
- •6. Patients who are able to understand the requirements of the study, and willing to provide voluntary written consent, abide by the study requirements and agree to return for required follow up visits.
- •7. Normal liver and renal function.
- •8. Vaccinated against Coronavirus Disease 2019(COVID-19).
- •Note: The participant must have received at least two doses of locally HA approved COVID-19 vaccine.
- •9. A COVID-19 antigen test by RT-PCR will be performed at Screening and on Day -1 upon admission to the CRU to exclude COVID-19 infection
- •Key Inclusion Criteria (CLI with wounds and ulcers):
- •1. M/F age group of 18-65 years of Indian origin
- •2. Any wound that has not shown a 20-40% reduction in area after 2-4 weeks of optimal treatment
- •3. No complete healing wound after 6 weeks or if there is poor response to a treatment change
- •4. Patients with primary venous insufficiency
- •5. Patients with venous ulcers with area larger than 2 cm2
- •6. Ulcers with negative acute wound infection
- •7. Patient has one Diabetic Foot Ulcer (DFU) on the study limb. The size of the DFU is no greater than 10 cm2
- •8. Negative pregnancy test when applicable
- •9. Absence of life-threatening complications
- •10. Vaccinated against Coronavirus Disease 2019 (COVID-19).
- •Note: The participant must have received at least two doses of locally HA approved COVID-19 vaccine.
- •11. A COVID-19 antigen test by RT-PCR will be performed at Screening and on Day -1 upon admission to the CRU to exclude COVID-19 infection
排除标准
- •From: Chrisann S
- •Date: Tuesday, 16 May 2023 at 10:40 AM
- •Subject: Exclusion Criteria - CLI
- •Exclusion Criteria for Chronic Lower Limb Ischemia patients without wounds and ulcer:
- •Patients meeting any of the exclusion criteria will be excluded from this study.
- •1. Patients who are pregnant, breastfeeding or intending to become pregnant
- •2. Patients with evidence of autoimmune liver disease (ANA or anti-LKM positivity)
- •3. Patients with Type 1 Diabetes or T2DM
- •4. Patients with CLI indicated for major amputation during screening
- •5. Patients having ulcers with exposure of tendon and/or bone in the shin region
- •6. Patients with gait disturbance for reasons other than CLI
- •7. Ankle Brachial Pressure Index (ABPI) > 0.6 or ankle pressure > 70 mm Hg in the foot
- •of the study limb
- •8. Patients who have clinically serious and/or unstable inter-current infection, medical
- •illnesses or conditions that are uncontrolled or whose control, in the opinion of the
- •Investigator, may be jeopardized by participation in this study or by the complications
- •of this therapy
- •9. Patients with documented terminal illness or cancer or any concomitant disease process
- •with a life expectancy of less than 1 year
- •10. Patients who have had previous above transmetatarsal amputation in study limb
- •11. Patients with clinically relevant peripheral neuropathy
- •12. Patients who are eligible for basic conservative and standard revascularization
- •13. Serum creatinine >=2 mg/dL
- •14. Serum sodium <129 mEq/L
- •15. Serum potassium >5.0 mEq/L
- •16. Neutrophil count <2,000/mm3
- •17. Platelet count <50,000/mm3
- •18. Patients with documented terminal illness or Cancer or any other concomitant disease
- •process with a life expectancy of less than 1 year.
- •19. Presence of active infectious disease
- •20. Presence of hepatic, portal, or splenic vein thrombosis
- •21. History of severe alcohol or drug abuse during 3 months before screening and
- •22. Unwilling to sign the informed consent
- •23. Other viral infections like HIV, HBV, HCV and CMV
- •24. Presence of blood system disease with high potential of hemocoagulation
- •25. Patients with Deep Vein Thrombosis in any limb
- •26. Patients with known hypersensitivity to the contents of the IMP
- •27. Participation in other clinical trials during previous 3 months
- •28. Any clinical condition, according to the investigator which does not allow safe
- •fulfillment of clinical trial protocol
- •29. Potential participant who has tested positive for active Coronavirus disease-2019
- •(COVID-19) within 3 months of Screening.
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