It depends on several factors and case to case, Consideration should be given to “best available therapy” control groups in the evaluation of a new therapy or intervention over an existing therapy. 

Refer to this article for detailed explanation: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2647647/

Thanks a lot, Dear Nina.

Regards!

Phase I clinical trial of cell therapy in patients with advanced chronic obstructive pulmonary disease: follow-up of up to 3 years

Talita Stessuk,1 Milton Artur Ruiz,2 Oswaldo Tadeu Greco,2 Aldemir Bilaqui,3 Maria José de Oliveira Ribeiro-Paes,4 andJoão Tadeu Ribeiro-Paes5

Abstract

Background

Chronic obstructive pulmonary disease is a major inflammatory disease of the airways and an enormous therapeutic challenge. Within the spectrum of chronic obstructive pulmonary disease, pulmonary emphysema is characterized by the destruction of the alveolar walls with an increase in the air spaces distal to the terminal bronchioles but without significant pulmonary fibrosis. Therapeutic options are limited and palliative since they are unable to promote morphological and functional regeneration of the alveolar tissue. In this context, new therapeutic approaches, such as cell therapy with adult stem cells, are being evaluated.

Objective

This article aims to describe the follow-up of up to 3 years after the beginning of a phase I clinical trial and discuss the spirometry parameters achieved by patients with advanced pulmonary emphysema treated with bone marrow mononuclear cells.

Methods

Four patients with advanced pulmonary emphysema were submitted to autologous infusion of bone marrow mononuclear cells. Follow-ups were performed by spirometry up to 3 years after the procedure.

Results

The results showed that autologous cell therapy in patients having chronic obstructive pulmonary disease is a safe procedure and free of adverse effects. There was an improvement in laboratory parameters (spirometry) and a slowing down in the process of pathological degeneration. Also, patients reported improvements in the clinical condition and quality of life.

Conclusions

Despite being in the initial stage and in spite of the small sample, the results of the clinical protocol of cell therapy in advanced pulmonary emphysema as proposed in this study, open new therapeutic perspectives in chronic obstructive pulmonary disease. It is worth emphasizing that this study corresponds to the first study in the literature that reports a change in the natural history of pulmonary emphysema after the use of cell therapy with a pool of bone marrow mononuclear cells.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3832317/

 Phase I studies assess the safety of a drug or device. This initial phase of testing, which can take several months to complete, usually includes a small number of healthy volunteers (20 to 100), who are generally paid for participating in the study. The study is designed to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur as dosage levels are increased. About 70% of experimental drugs pass this phase of testing.

However for cancer drugs, clinical trials are carried out in patients

Phase I studies are conducted with volunteering patients in cases when medical products have safety concerns. It is considered unethical to expose health volunteers to products eliciting serious adverse drug reactions. Typically patient enrolled to such studies have terminal diseases and have no other options for therapeutic benefits. Often one enrollment of patients in oncology - chemotherapeutics with potential serious adverse reactions are offered to patients who exhausted all treatment possibilities.  As at this point the efficacy, safety and correct dose of the chemotherapeurtic is not established yet, the patients very rarely benefit from phase I studies.  Very, very rare patient may benefit from the study. One motive of joining such study is a hope of potential benefit (often described as "therapeutic misconception") and other motive is willingness to contribute to medical research. 

Urszula

Thank you very much to everybody for your participation.

Best regards.

Normally,  Phas 1 Clinical study has to be done in small number of  healthy volunteers  in order to find out the safety of the new agent  human.

Thank you 

Phase-1 clinical trial is conducted by Testing within a small group of people (20–80) to evaluate safety, determine safe dosage ranges, and begin to identify side effects. A drug's side effects could be subtle or long term, or may only happen with a few people, so phase 1 trials are not expected to identify all side effects.

In my earlier answer  I used the word  normally,  but some times in HIV or Cancer drugs ,may include patients  under the closed supervision of a clinical  investigator.  Anyway,  the aim of first  clinical phase is not to to study the  safety of the drug. Further aims for the first phase are to study : the pharmacodynamics, pharmacokinetic, the pharmacovigillance, the tolerance and her important clinical features  of the drug.

Thank All. Phase I studies were without  direct benefit for the healthy subject. That's why, they receive an allowance for the constraints. Thus, because of known toxicity of anti-cancer, it cannot be used on healthy subject to preserve their integrity. Best regards

Hi, 

Normally, in Phase I of the clinical Trial healthy human subjects are involved but in case of the drugs of HIV, Cancer and other drugs with serious Adverse Effects or life threatening effects then  patients are to be involved for conducting the Trials.