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About
Patients receiving radiation therapy are still at risk for side effects due to off-target radiation damage of normal tissues The number of cancer patients is expected to increase from 14.1 million around the world in 2012 to 19.3 million in 2025. Up to ten percent will develop late severe gastrointestinal complications (i.e. Pelvic Radiation Disease - PRD). Symptoms are proctopathy (5-20%) and radiation-induced cystitis (3,5%) that affect quality of life. The treatment of PRD is limited to managing the symptoms; new alternatives should be proposed.
Clinical trials using MSCs to treat hemorrhagic cystitis, proctopathy have demonstrated the feasibility to used MSCs in these pathologies :
MSCs will represent a promising alternative strategy in the treatment of severe enteritis, rectitis and cystitis after radiotherapy, and may avoid surgical treatment and may diminish the adverse effect of PRD in terms of chronicity, morbidity, mortality and health costs.
Full description
-Chemo-radiation enhances survival but also increases the risk of PRD. The result will be an increasing
Results from conventional therapies for PRD reveal a poor long-term efficacy:
i. Coagulation by plasma argon is insufficient, 58% at 6 months; ii. The efficacy of formalin is questionable (48%), as is 5-amino-salicylate, sulfasalazine, vitamin E and pentoxifylline ; iii. The efficacy of short chain fatty acids and hyperbaric oxygen therapy is low (40%); iv. Steroids are of limited efficacy (37%). v. A surgical operation in an irradiated field is associated with difficult or impossible healing as well as with risks of infection (mortality of 5% within 40 months) Furthermore, conventional therapies are palliative and badly tolerated. More effective approaches are thus crucial.
PRD unfortunately remains a major side effect of radiotherapy and there is no established effective treatment. Consequently, the recruitment of the aforementioned number of patients by participating radiotherapy centers is ensured.
MSC therapy is a safe and suitable option in severe PRD.
PRISME is a network project which includes St Antoine Hospital, INSERM (National Institute of Health and Medical Research), EFS (French Blood Establishment ), CTSA (Army Centre of Blood Transfusion) ECellFrance, IRSN (Institute for Radiological Protection and Nuclear Safety), IGR (Gustave Roussy Institute), and Institute of cancerology of west France. Our consortium has robust experience of the treatment of radiation damages, preclinical models and the medical management of PRD using biotherapy. Clinical and scientific achievements, previous collaborations of the different groups and preliminary partner's data assure the fulfillment of the program.
It is expected to achieve the healing of chronic refractory diseases, leading to lower health expenses by reducing patient treatment and hospitalization, and to an increase in their quality of life by a:
The expected results for the public will be the healing of chronic refractory diseases, leading to lower health expenses by reducing patient treatment and hospitalization, and to an increase in their quality of life.
Hypothesis: MSC injections provide an efficient alternative approach in the treatment of PRD for patient refractories to conventional treatments.
Patient study scheduled:
D-60: Screening by 6 radiotherapy centers. D-1: Inclusion in Saint Antoine Hospital. D0, D7 and D14: IV MSC injection (2x106 - 6x106/kg MSC). M2 and M4: follow-up visit. End of patient's participation to the study at M4. Total number of scheduled patients: 12 patients suffering from PRD. Simon minimax plan, P0=25%, P1=60%, Alpha=5% and Beta=20%.
Stopping rules:
Step 1: (n1=5) inclusion of 5 patients r1=1: if the number of success is <2, the study will end for MSC inefficacy. If the number of success is ≥2, proceed to step 2. Step 2: (n2=7) inclusion of up to 7 patients r2=5: as soon as the number of successes reaches 6 (>r2), inclusions will be discontinued and MSC will be considered as sufficiently promising for further studies.
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12 participants in 1 patient group
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Alain CHAPEL, PhD; Mohamad MOHTY, PhD
Data sourced from clinicaltrials.gov
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