The safety and efficacy of combination treatment using adipose derived adult stem cells, platelet-rich-plasma and peptides on patients with Multiple Sclerosis.

• Conditions: Multiple Sclerosis; Neurological - Multiple sclerosis

• Registration Number: ACTRN12615000687594
• Lead Sponsor: MasterCell Stem Cell Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability score compared to baseline assessed by Multiple Sclerosis Functional Composite (MSFC revised) score[Post-procedure: 3 months, 6 months, 12 months];Change from baseline of disability and health status: Scale (EDSS-revised).<br><br>[Post-procedure: 3 months, 6 months, 12 months];Patient Reported Outcomes (PROs): MS Impact Scale (MSIS-29).[Post-procedure: 3 months, 6 months, 12 months]

Secondary Outcome Measures

Name	Time	Method
The safety of protocol will be evaluated by assessment of the number, time-frame of occurrence and severity of Adverse Events (Adverse Events will be graded by the Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) and coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology. Adverse events monitoring will consist of measurement of vital signs (temperature, heart rate, blood pressure, respiration) and relevant blood tests if indicated.[day of procedure, and 1 week follow-up visit and participants reports throughout trial.]