Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02216630
• Date of registration: 07/08/2014
• Prospective Registration: No
• Primary sponsor: Kimera Society Inc
• Public title: Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease
• Scientific title: An Open-label, Non-Randomized, Multi-center Study to Assess the Safety and Effects of Intravenous Implantation of Liposuction Derived Autologous Adipose-derived Stem Cells in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
• Date of first enrolment: August 2014
• Target sample size: 26
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02216630
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Costa Rica, Nicaragua, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 18 to 85, inclusive

- A prior diagnosis of moderate to severe COPD

- GOLD IIa, III, IV

Exclusion Criteria:

- Pregnant or lactating

- Life expectancy < 6 months due to concomitant illnesses.

- Exposure to any investigational drug or procedure within 1 month prior to study entry
or enrolled in a concurrent study that may confound results of this study.

- Any illness which, in the Investigators judgment, will interfere with the patient's
ability to comply with the protocol, compromise patient safety, or interfere with the
interpretation of study results

- Subjects on chronic immunosuppressive or chemotherapeutic therapy

- Known drug or alcohol dependence or any other factors which will interfere with the
study conduct or interpretation of the results or who in the opinion of the
investigator are not suitable to participate.

- Subjects with Alpha-1 antitrypsin deficiency (an inherited disorder that can cause
lung disease and liver disease).

- Unwilling and/or not able to give written consent

- Patient is positive for hepatitis (past history of Hepatitis A is allowed)

- Any medical condition, which in the opinion of the clinical investigator, would
interfere with the treatment or outcome of the patient

- Cerebral aneurysm clips



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease

Intervention(s)

Drug: Adipose Derived Stem Cell (ADSC) Therapy

Primary Outcome(s)

FEV1 Decline [Time Frame: 12 months]

Number of Adverse Events [Time Frame: 12 months]

Secondary Outcome(s)

Secondary Efficacy Objective [Time Frame: 12 Months]

Secondary ID(s)

KS-SVF-1002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors