None listed
Conditions
Brief summary
Recent research and clinical evidence indicates that Human adipose-derived stem cells are safe for use in Humans. Researchers suggest that the treatment may alter the operation of the immune system to ameliorate degenerative activity. In a conducive environment supported by a combination of growth factors and certain peptides, stem cells can also be stimulated to differentiate into a range of different cell types when transported to the site of degradation. This trial is investigating to what extent an injection of the Stromal Vascular Fraction obtained from the participants own fat tissue and Platelet-Rich-Plasma, and in combination with proprietary peptides reduces the progression of disease and improves quality of life. The peptides are derived from those that are naturally present throughout the body and are critical to cellular processes particularly growth and regeneration. Age and disease conditions can reduce the levels and effectiveness of these peptides which normally promote healing. This study involves patients with neuro-degenerative disease specifically, multiple sclerosis of all categories.
Interventions
This study aims to evaluate the efficacy and safety of treatments using Autologous, Non-Expanded, Adipose Derived Stem Cells (stromal vascular fraction, SVF), platelet-rich-plasma (PRP) and peptides on patients with Multiple Sclerosis (MS). Patients are assessed using inclusion and exclusion criteria, in order to determine whether they are eligible for an Autologous Stem cell transplant. If eligible, patients are prescribed, three proprietary peptide injections (growth factors) (dosage- 0.1 - 0.
This study aims to evaluate the efficacy and safety of treatments using Autologous, Non-Expanded, Adipose Derived Stem Cells (stromal vascular fraction, SVF), platelet-rich-plasma (PRP) and peptides on patients with Multiple Sclerosis (MS). Patients are assessed using inclusion and exclusion criteria, in order to determine whether they are eligible for an Autologous Stem cell transplant. If eligible, patients are prescribed, three proprietary peptide injections (growth factors) (dosage- 0.1 - 0.2 ml each, daily self-injection, 5 days/week for 4 weeks prior to liposuction procedure. The peptides are derived from those that are present naturally throughout the body and are critical to cellular processes particularly growth and regeneration. The ongoing maintenance dose of the peptides via injection is necessary due to their short half-life and most effective circulation and absorption. One injection continues for 5 weeks post-procedure while the other 2 injections continue for the trial duration) and specific Vitamin D3 dietary supplement (dosage- 4 capsules (1000 IU per capsule) per day starting 3 weeks prior and up to stem cell collection procedure). The procedure commences with extraction of whole blood (60 ml) followed by preparation of PRP (approximately 7 ml) which is later combined with the SVF preparation for injection. Within the SVF, there will be an approximate minimum of 10^6 viable, nucleated cells deployed per kg body weight. Liposuction using local anaesthesia and syringe collection will be performed to collect the adipose tissue specimen (50 ml) for subsequent processing to isolate the SVF. SVF and PRP are filtered and irradiated. This preparation is administered with saline solution intravenously. Following the procedure, standard supportive measures including antimicrobial prophylaxis are followed as per clinic protocols. The duration of the day procedure including extraction, processing and injection is ~ 7 hours. This procedure and treatment is administered only once. Any adverse events are monitored at procedure and at 1 week follow-up visit. Monitoring is continued remotely for the trial duration. Condition specific validated questionnaires and physiological tests are applied at subsequent interviews at 3, 6, and 12 months via telephone and internet utilities. Data will be compared with previous medical history and baseline measurements taken before procedure.
Sponsors
MasterCell Stem Cell Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients who give written consent to participate in the study. Patients diagnosed with Multiple Sclerosis clinically defined and supported by laboratory tests (eg: MRI) (revised McDonald criteria (2010)). Active MS, defined by: At least one outbreak in the last year or at least one Gadolinium enhancing lesion in the last 6 months. EDSS (1.5) to (6.5) at screening evaluation.
Exclusion criteria
Inability to give informed consent Known allergies/ hypersensitivities to local anaesthetics or antibiotics Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results Females who are pregnant (detected by urinary hCG in fertile women) or lactation or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study. Anti-coagulant use (as below) that cannot be stopped or bleeding disorders (no use of Warfarin, Aspirin, Vitamin E, fish oil or anti-inflammatory medications 10 days before treatment) Active or chronic infectious disease including infection with HIV1-2 or chronic Hepatitis B or Hepatitis C. For patients who have tested positive, an expert will be consulted as to patient eligibility based on the patient's infectious status. Known drug or alcohol dependence. Immunosuppressed. Congestive heart failure (NYHA III / IV), cardiomyopathy, heart rhythm disorder requiring treatment, unstable or severe heart disease (CCS III or IV), severe hypertension (systolic greater than 180, diastolic greater than 110). Systolic blood pressure (supine) =90 mmHg; Resting heart rate > 100 bpm; Cerebrovascular accident within 6 months prior to study entry. History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years. Previously demonstrated hematologic disease. Abnormal blood counts, a history of myelodysplasia or other cytopenia. Patients with WBC count less than 3000 cells per microliter, platelets less than 100,000 cells per microliter and un-transfused hemoglobin less than 10 grams per deciliter. Previously demonstrated renal insufficiency (e.g. serum creatinine clearance less than 30ml/min) or An estimated glomerular filtration rate (eGFR)< 60 mL/min/1.73m2 history Exposure to any investigational drug or procedure within 6 weeks prior to study entry or enrolled in a concurrent study that may confound results of this study. Participation in clinical trials of any experimental drugs in the 6 months before study entry. Interferon beta or Glatiramer acetate 6 weeks prior to screening Treatment with Alemtuzumab (campath-1H) within the last 2 years. Experimental treatment within 3 months prior to screening Patients with EDSS less than 1.5 or greater than 6.5. Patients on chronic immunosuppressive transplant therapy. Immunosuppressive agents ( eg., Glucocorticosteroid therapy within the last 6 weeks), Natalizumab or Fingolimod in the 3 months prior to screening.
Outcome results
None listed