Health Condition 1: I999- Unspecified disorder of circulatory system
Conditions
Interventions
Intervention1: Fetal Progenitor Cells: Fetal Progenitor Cell (0.2ml/kg body weight, IV, administered on 2,3,4 visit
0.2ml mixed cell suspension per inj, IM)
Control Intervention1: Bone Marrow Autolog
Sponsors
Relabs Private Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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) 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
Exclusion criteria
Exclusion criteria: From: Chrisann S Date: Tuesday, 16 May 2023 at 10:40 AM To: 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 15. Serum potassium >5.0 mEq/L 16. Neutrophil count 17. Platelet count 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 enrollment 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Ankle Brachial Index (ABI)Timepoint: baseline to 12 months (Timeframe: Baseline, 1,3,6 and 12 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Total Walking Distance 2.Pain free walking distance on a standardized treadmill test 3.Toe Brachial Pressure Index from baseline to 12 months (Time frame Baseline, 1,3,6 and 12 months) 4.Wong-Baker FACES pain rating scale scoreTimepoint: Baseline and Month 12 | — |
Countries
India
Contacts
Public ContactKunal Bhatt
Reelabs Private Limited
Outcome results
None listed