Safety, Tolerability and Preliminary Efficacy of Adipose Derive Stem Cells for Patients With COPD

Arkansas Heart Hospital

Status and phase: Terminated; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Biological: ADSCs administration

Study type: Interventional

Funder types: Other

Identifiers

NCT02161744

ICMS-2013-25

Details and patient eligibility

About

The purpose of this study is: 1.- to assess the safety and tolerability of autologous adipose derived stem cells (aADSC) administered intravenously in patients with chronic obstructive pulmonary disease, and 2.- to assess if this therapy results in less decrease of lung function parameters (FEV1, FEV1/FVC and 6 min walking distance) compared with a control baseline of 6 weeks.

Patients will be followed up for 12 months after the therapy.

Full description

STUDY DESIGN This is a Phase I open- label single-dose study in subjects with significant COPD. This is an expanded safety cohort. The investigators will enroll a minimum of 30 subjects. 6 week data of FEV1, FEV1/FVC, DLCO and 6 min walking distance values will be collected in all patients who are enrolled in the study (Baseline and 6 weeks after). Prior to the stem cell treatment, the patient will be assessed for 6 weeks by pulmonary function tests and 6 min walk tests. Then, patients will receive the infusion of stromal vascular fraction cells containing the aADSC (single intravenous dose). The standard therapy of COPD patients will not be interrupted during the duration of the study. Safety will be monitored on an ongoing basis, and an interim safety review will be conducted by the Investigator(s) and Sponsor after the first 20 patients have been enrolled and treated.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and Females ≥18 years.

2. Cognitive competitiveness.

3. Diagnosis of at least moderate COPD (postbronchodilator FEV1/FVC < 70% (<0.7), FEV1 < 80% predicted).

4. Diffusing capacity impairment (DLCO) assessed by single breath test (corrected for alveolar volume, 'DLVA').

5. Life expectancy greater than 12 months.

6. Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf.

7. Reasonable expectation that patient will receive standard post-treatment care and attend all scheduled safety follow-up visits.

8. No changes in active pulmonary medications for heart failure during the two weeks prior enrollment.

9. Written informed consent. 11. Non-smoker or Past smoker, with 20 pack-years or more history

Exclusion criteria

1. Current smokers.
2. Unstable coronary disease.
3. Patients with industrial exposure to silica and/or asbestos or giant bullae.
4. Uncontrolled seizure disorder.
5. Dementia.
6. Presence of immune deficiency or autoimmune disease.
7. Alpha- 1 antitrypsin deficiency.
8. Cor pulmonale or diastolic heart failure NYHA class III or IV
9. Type 1 diabetes mellitus
10. Complicated type 2 diabetes mellitus.
11. Active tuberculosis or severe lung damage due to tuberculosis (extensive cavitation).
12. History of cancer within the past 5 years.
13. Clinically-significant hematologic, hepatic, or renal impairment as determined by screening clinical laboratory tests.
14. Systemic corticosteroids, cytostatics, immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), and DNA depleting or cytotoxic drugs taken within four weeks prior to study treatment.
15. Porphyria.
16. Allergy to sodium citrate or any "caine" type of local anesthetic.
17. Abnormal findings could include: known HIV infection or other immunodeficiency state, chronic active viral infection (such as hepatitis B or C), acute systemic infections (defined as patients undergoing treatment with antibiotics), gastrointestinal tract bleeding, or any severe or acute concomitant illness or injury.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

ADSCs administration

Experimental group

Description:

Patients with Chronic Obstructive Pulmonary Disease will be treated with a single dose of autologous adipose derived stem cells. Stem cells will be isolated using standard Lipoaspiration procedure under sterile conditions.

Treatment:

Biological: ADSCs administration