Effectiveness and Safety of Adipose-Derived Regenerative Cells for the Treatment of Critical Lowe… (NCT02864654) | Clinical Trial Compass
UnknownPhase 1/2
Effectiveness and Safety of Adipose-Derived Regenerative Cells for the Treatment of Critical Lower Limb Ischemia
Russia9 participantsStarted 2016-07
Plain-language summary
Adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic digestion. 10 mL of autologous ADRC suspension injected intramuscularly, close to the site of muscle injury. All patients will receive cell therapy. This is a single arm study with no control.
Who can participate
Age range50 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with critical lower limb ischemia, with resting pain wich can't be adequately managed by opioid analgetics and/or foot ulcers or necrosis, with II-4, III-5 и IV-6 stages of chronic arterial failure according to Rutherford's classification
* Ankle-brachial index less than 0.4 and/or ТСрО2 less than 30 mm Hg
* Patients with lower limbs' arteries lesions revealed by angiography uneffectiveness or impossibility of limb's revascularisation or patient's refusal of the procedure
* Patient is familiar with Participant information sheet
* Patient signed informed consent form
Non-inclusion Criteria:
* Contraindications for local anesthesia or history of allergy for local anesthetics
* Systemic glucocorticoid and/or immunosuppressant therapy
* Any condition that might limit compliance (dementia, mental disorders, narcotic drug or alcohol abuse etc.)
* Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
* Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy
* Clinically significant abnormalities in results of laboratory tests
* Patient received anticoagulants at least 12 hours prior the liposuction
* Medical history of heterotopic ossifications
* Patients prescribed for glycoprotein inhibitors treatment
Exclusion Criteria:
* Patient's refusal from the further participation in trial
* Chronic kidney disease IV- V stages (creatini…
What they're measuring
1
Serious adverse events
Timeframe: 4 weeks after injection of ADRC suspension
2
Serious adverse reactions
Timeframe: 4 weeks after injection of ADRC suspension
Trial details
NCT IDNCT02864654
SponsorCentral Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation